<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03760081</url>
  </required_header>
  <id_info>
    <org_study_id>1650-CL-0201</org_study_id>
    <nct_id>NCT03760081</nct_id>
  </id_info>
  <brief_title>A Study to Assess the Safety and Efficacy of ASP1650, a Monoclonal Antibody Targeting Claudin 6 (CLDN6), in Male Subjects With Incurable Platinum Refractory Germ Cell Tumors</brief_title>
  <official_title>A Phase 2, Open-Label, Single-Arm, Multicenter Study to Assess the Safety and Efficacy of ASP1650, a Monoclonal Antibody Targeting Claudin 6 (CLDN6), in Male Subjects With Incurable Platinum Refractory Germ Cell Tumors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Astellas Pharma Global Development, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Astellas Pharma Inc</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study was to establish the recommended phase 2 dose (RP2D) of ASP1650&#xD;
      (Safety Lead-in Phase), as well as, evaluate the efficacy of ASP1650 as measured by confirmed&#xD;
      objective response rate (ORR) (phase 2) in participants with incurable platinum refractory&#xD;
      germ cell tumors.&#xD;
&#xD;
      This study also evaluated the following efficacy measures for confirmed objective response&#xD;
      rate (ORR); clinical benefit rate (CBR); duration of response (DOR); and progression-free&#xD;
      survival (PFS); as well as safety and tolerability; the effect of ASP1650 on changes in serum&#xD;
      beta human chorionic gonadotropin (βhCG) and alpha-fetoprotein (AFP); and the&#xD;
      pharmacokinetics of ASP1650.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study consisted of 2 phases: Safety Lead-in phase and phase 2. 19 participants were&#xD;
      enrolled in both phases.&#xD;
&#xD;
      The Safety Lead-in phase of this study was to establish the tolerability of RP2D. The RP2D&#xD;
      determination was based on at least 6 evaluable participants at the RP2D as determined by the&#xD;
      Dose Evaluation Committee (DEC).&#xD;
&#xD;
      Once RP2D had been established as tolerable, 13 additional participants were enrolled in&#xD;
      phase 2 to receive ASP1650 for up to a maximum of 12 cycles or until a study discontinuation&#xD;
      criteria had been met, whichever occurred earlier.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 19, 2019</start_date>
  <completion_date type="Actual">October 16, 2020</completion_date>
  <primary_completion_date type="Actual">October 16, 2020</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Recommended Phase 2 Dose (RP2D) of ASP1650</measure>
    <time_frame>Up to 28 days</time_frame>
    <description>The RP2D was determined via dose limiting toxicity (DLT) assessment by dose evaluation committee (DEC). DLT was evaluated according to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTCAE) version 5.0.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With Confirmed Objective Response by Modified RECIST v1.1</measure>
    <time_frame>From randomization until confirmed CR or confirmed PR, whichever occurred first (up to 26.57 weeks)</time_frame>
    <description>Confirmed objective response was defined as the confirmed completed response (CR) or confirmed partial response (PR), as confirmed by investigator based on modified Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Per modified RECIST v1.1, CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to &lt;10 mm. Both Alpha-Fetoprotein (AFP) and Beta Human Chorionic Gonadotropin (beta-HCG) values were below the ULN. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. No increase ≥ 50% in 2 samples at least 1 week apart compared to nadir values for both AFP and beta-HCG.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Confirmed Objective Response by RECIST v1.1</measure>
    <time_frame>From randomization until confirmed CR or confirmed PR, whichever occurred first (up to 26.57 weeks)</time_frame>
    <description>Confirmed objective response was defined as the confirmed CR or PR, as confirmed by investigator based on RECIST v1.1. Per RECIST v1.1, CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to &lt;10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Clinical Benefit by Modified RECIST v1.1 and RECIST v1.1</measure>
    <time_frame>From randomization until confirmed CR, confirmed PR, or durable SD whichever occurred first (up to 26.57 weeks)</time_frame>
    <description>Clinical benefit: defined as best overall response of confirmed CR, confirmed PR, or durable stable disease (SD) as confirmed by investigator based on modified RECIST v1.1 and RECIST v1.1. Per RECIST v1.1 and modified RECIST V1.1, CR: disappearance of all target lesions. Any pathological lymph nodes(whether target or non-target) must have reduction in short axis to &lt;10 mm. PR:at least a 30% decrease in sum of diameters of target lesions, taking as reference baseline sum diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference smallest sum diameters while on study. Durable SD: SD maintained for at least 12 weeks. Additionally, per modified RECIST v1.1, CR also included AFP and beta-HCG values below ULN. PR also included no increase ≥ 50% in 2 samples at least 1 week apart compared to nadir values both for AFP and beta-HCG.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Response (DOR) by Modified RECIST v1.1 and RECIST v1.1 for Dose Level 2</measure>
    <time_frame>From randomization until confirmed CR or confirmed PR whichever occurred first (up to 26.57 weeks)</time_frame>
    <description>DOR was defined as the time from the date of the first confirmed response CR or confirmed PR (whichever was first recorded) as confirmed by investigator based on modified RECIST 1.1 and RECIST v1.1 to the date of disease progression or date of censoring, whichever was earlier. If a participant had not progressed, participant was censored at the date of last disease assessment or at the date of first confirmed CR/PR if no post-baseline disease assessment was available. DOR (in days) was calculated as: (Date of documented progressive disease [PD], death, or censoring) minus (Date of the first CR/PR which was subsequently confirmed) +1. Duration of response was planned to summarized only for participants receiving dose level 2 in phase 2.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-Free Survival (PFS) by Modified RECIST v1.1 and RECIST v1.1 for Dose Level 2</measure>
    <time_frame>From the date of first dose until the date of disease progression, or until death due to any cause (up to 26.57 weeks)</time_frame>
    <description>PFS was defined as the time from the date of first dose until the date of disease progression, or until death due to any cause. If a participant had neither progressed nor died, the participant was censored at the date of last disease as confirmed by investigator based on modified RECIST v1.1 and RECIST v1.1. The distribution of PFS was planned to be summarized only for participants receiving dose level 2 using Kaplan-Meier methodology. Per modified RECIST v1.1 and RECIST v1.1, Progressive disease (PD): appearance of one or more new lesions or at least a 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study (this includes the baseline sum if that is the smallest on study). Also, the sum must be an absolute increase of at least 5 mm. Additionally per modified RECIST v1.1, PD was increase ≥ 50% in serum tumor markers AFP or beta-hCG in 2 samples at least 1 week apart compared to nadir values.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Adverse Events (AEs)</measure>
    <time_frame>From first dose of study drug up to 30 days after the last dose of study drug (up to 41.14 weeks)</time_frame>
    <description>An AE was defined as any untoward medical occurrence in a participant administered with an Investigational Product (IP) which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign including abnormal laboratory finding/test result or other safety assessment, symptom, or disease temporally associated with use of IP whether or not considered related to IP. A treatment-emergent adverse event (TEAE) was defined as an AE with onset at any time from first dosing until last scheduled procedure. AEs were considered serious (SAEs) if AE resulted in death, was life-threatening, resulted in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, resulted in congenital anomaly, birth defect, or required inpatient hospitalization or led to prolongation of hospitalization.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Shifts From Baseline to Post Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG PS)</measure>
    <time_frame>Baseline, C2D1, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1, C9D1, C10D1, C11D1, C12D1 (Duration of each treatment cycle was 14 days)</time_frame>
    <description>Number of participants with shifts from baseline to post baseline in ECOG PS levels were reported. ECOG has 6 levels (0-5). Level 0 is fully active, able to carry on all pre-disease performance without restriction; Level 1 is restricted in physically strenuous activity but ambulatory ad able to carry out work of a light or sedentary nature, e.g. light house work, office work; Level 2 is ambulatory and capable of all self care but unable to carry out any work activities; up and about more than 50% of waking hours; Level 3 is capable of only limited self care; confined to bed or chair more than 50% of waking hours; Level 4 is completely disabled; cannot carry on any self care; totally confined to bed or chair); and Level 5 is dead.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Serum Beta Human Chorionic Gonadotropin (βhCG)</measure>
    <time_frame>Baseline, Cycle 2 Day 1 (C2D1), C3D1, C4D1, C5D1, C6D1, C7D1, C8D1, C9D1, C10D1, C11D1, C12D1 (duration of each cycle was 14 days)</time_frame>
    <description>Blood was drawn for the measurement of serum βhCG at day 1 of every cycle (14 day cycle) to align with imaging assessment until the participant develops radiological disease progression per RECIST v1.1 evaluation or starts other systemic anticancer treatment. To evaluate the effect of ASP1650 on changes in serum βhCG, disease response was derived for participants with elevated serum tumor markers at baseline using CR, PR and SD.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Serum Alpha-Fetoprotein (AFP)</measure>
    <time_frame>Baseline, C2D1, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1, C9D1, C10D1, C11D1, C12D1 (duration of each cycle was 14 days)</time_frame>
    <description>Blood was drawn for the measurement of serum AFP at day 1 of every cycle (14 day cycle) to align with imaging assessment until the participant develops radiological disease progression per RECIST v1.1 evaluation or starts other systemic anticancer treatment. To evaluate the effect of ASP1650 on changes in serum AFP, disease response was derived for participants with elevated serum tumor markers at baseline using CR, PR and SD.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics (PK) of ASP1650 in Plasma: Area Under the Concentration-Time Curve Over 336 Hours (AUC336)</measure>
    <time_frame>Dose Level 1 - CID1, C3D1: predose, 1.5 h after start of infusion, immediately after end of infusion, 0.5, 1.5, 3, 6, 24, 48, 72 h after end of infusion; Dose Level 2 - C1D1, C3D1: predose, immediately after end of infusion</time_frame>
    <description>AUC336 was derived from the Pharmacokinetic (PK) plasma samples collected. Duration of each cycle was 14 days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics (PK) of ASP1650 in Plasma: Maximum Concentration (Cmax)</measure>
    <time_frame>Dose Level 1-CID1, C3D1: predose, 1.5 h after start of infusion, immediately after end of infusion, 0.5, 1.5, 3, 6, 24, 48, 72 h after end of infusion; Dose Level 2-C1D1, C3D1: predose, immediately after end of infusion</time_frame>
    <description>Cmax was derived from the PK plasma samples collected. Duration of each cycle was 14 days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics (PK) of ASP1650 in Plasma: Time to Maximum Concentration (Tmax)</measure>
    <time_frame>Dose Level 1- CID1, C3D1: predose, 1.5 h after start of infusion, immediately after end of infusion, 0.5, 1.5, 3, 6, 24, 48, 72 h after end of infusion; Dose Level 2- C1D1, C3D1: predose, immediately after end of infusion</time_frame>
    <description>Tmax was derived from the PK plasma samples collected. Duration of each cycle was 14 days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics (PK) of ASP1650 in Plasma: Concentration Immediately Prior to Dosing at Multiple Dosing (Ctrough)</measure>
    <time_frame>C2D1,C3D1,C4D1,C5D1,C6D1,C7D1,C8D1,C9D1,C10D1,C11D1,C12D1:predose,1.5 h post start of infusion, immediately post end of infusion,0.5,1.5,3,6,24,48,72 h post end of infusion for Dose Level 1, and predose, immediately post end of infusion for Dose Level 2</time_frame>
    <description>Ctrough was derived from the PK plasma samples collected. Duration of each cycle was 14 days.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">19</enrollment>
  <condition>Incurable Platinum Refractory Germ Cell Tumors</condition>
  <condition>Tumors</condition>
  <arm_group>
    <arm_group_label>ASP1650, Dose Level 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received ASP1650 dose level 1 as intravenous infusion, every two weeks (Q2W) starting on Cycle 1 Day 1(C1D1) for up to a maximum of 12 cycles, or until disease progression, toxicity requiring study treatment cessation, start of another anticancer treatment, or until study discontinuation criteria was met, whichever occurred earlier. Duration of each treatment cycle was 14 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ASP1650, Dose Level 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received ASP1650 dose level 2 as intravenous infusion, Q2W starting on C1D1 for up to a maximum of 12 cycles or until study discontinuation criteria as met, whichever occurred earlier. Duration of each treatment cycle was 14 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ASP1650</intervention_name>
    <description>Participants received ASP1650 dose level 1 or dose level 2 as intravenous infusion, Q2W starting on C1D1 for up to a maximum of 12 cycles or until study discontinuation criterion was met, whichever occurred earlier. Duration of each treatment cycle was 14 days.</description>
    <arm_group_label>ASP1650, Dose Level 1</arm_group_label>
    <arm_group_label>ASP1650, Dose Level 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  A male subject with female partner(s) of child-bearing potential must agree to use&#xD;
             contraception during the treatment period and for at least 6 months after the final&#xD;
             study drug administration.&#xD;
&#xD;
          -  Subject must not donate sperm during the treatment period and for 6 months after the&#xD;
             final study treatment administration.&#xD;
&#xD;
          -  A male subject with a pregnant or breastfeeding partner(s) must agree to remain&#xD;
             abstinent or use a condom for the duration of the pregnancy or time partner is&#xD;
             breastfeeding throughout the study period and for 6 months after the final study&#xD;
             treatment administration.&#xD;
&#xD;
          -  Subject agrees not to participate in another interventional study while receiving&#xD;
             study drug in present study.&#xD;
&#xD;
        Disease Specific Criteria:&#xD;
&#xD;
          -  Subject has histological evidence of germ cell tumor.&#xD;
&#xD;
          -  Subject must have a germ cell tumor that is not amenable to cure with either surgery&#xD;
             or chemotherapy.&#xD;
&#xD;
          -  Subjects with seminoma and non-seminoma are eligible.&#xD;
&#xD;
          -  Subject must have received initial cisplatin based combination chemotherapy AND&#xD;
             demonstrated progression following at least 1 salvage regimen for advanced germ cell&#xD;
             neoplasm (including relapsed primary mediastinal nonseminomatous germ cell tumor).&#xD;
&#xD;
               1. Initial cisplatin based combination therapy includes&#xD;
                  bleomycin-etoposide-cisplatin, cisplatin-etoposide,&#xD;
                  etoposide-ifosfamide-cisplatin or similar regimens.&#xD;
&#xD;
               2. &quot;Salvage&quot; regimens include high dose chemotherapy,&#xD;
                  paclitaxel-ifosfamide-cisplatin, vinblastine-ifosfamide cisplatin or similar&#xD;
                  regimens&#xD;
&#xD;
               3. &quot;Failure&quot; of prior therapy is defined as: A &gt; 25% increase in the products of&#xD;
                  perpendicular diameters of measurable tumor masses during prior therapy, which&#xD;
                  are not amenable to surgical resection; OR the presence of new tumor that are not&#xD;
                  amenable to surgical resection; OR an increase in alpha-fetoprotein (AFP) or beta&#xD;
                  human chorionic gonadotropin (βhCG) (≥ 50% increase in 2 separate samples&#xD;
                  collected at least 1 week apart are required if rising tumor markers are the only&#xD;
                  evidence of failure). NOTE: Subjects with clinically growing teratoma (enlarging&#xD;
                  mature teratoma arising during or after chemotherapy for a non seminomatous&#xD;
                  germ-cell tumor and with normal serum levels of AFP and βhCG) should undergo&#xD;
                  surgical resection if feasible.&#xD;
&#xD;
          -  Subjects with late relapse (&gt; 2 years) not amenable to resection are eligible.&#xD;
&#xD;
          -  Subjects must have evidence of recurrent or metastatic carcinoma by 1 or more of the&#xD;
             following:&#xD;
&#xD;
               1. Subject has measurable disease according to Response Evaluation Criteria in Solid&#xD;
                  Tumors (RECIST) 1.1 within 28 days prior to the first dose of study treatment.&#xD;
                  For subjects with only 1 measurable lesion and prior radiotherapy, the lesion&#xD;
                  must be outside the field of prior radiotherapy or must have documented&#xD;
                  progression following radiation therapy.&#xD;
&#xD;
               2. Subject has a baseline rising tumor marker (AFP or βhCG). NOTE: If a rising tumor&#xD;
                  marker is the only evidence of progressive disease, at least 2 consecutive rising&#xD;
                  values at least 1 week apart are needed. Subjects with only evidence of disease&#xD;
                  as rising tumor marker AFP and βhCG will be assessed for alternate causes of&#xD;
                  increased serum levels of these markers, such as cross reaction with luteinizing&#xD;
                  hormone (LH) (can be tested if needed by testosterone suppression of LH),&#xD;
                  hepatitis, use of marijuana or second primary tumor.&#xD;
&#xD;
        Physical or Laboratory Findings:&#xD;
&#xD;
          -  Subject must have an available tumor specimen in a tissue block or unstained serial&#xD;
             slides, or subject is an appropriate candidate for tumor biopsy and is amenable to&#xD;
             undergoing a tumor biopsy during the screening period.&#xD;
&#xD;
          -  Subject has Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.&#xD;
&#xD;
          -  Subject must meet all of the following criteria based on the centrally analyzed&#xD;
             laboratory tests within 14 days prior to the first dose of study treatment. If repeat&#xD;
             screening labs are required, local laboratory results can be used to confirm&#xD;
             eligibility. In case of multiple central laboratory data within this period, the most&#xD;
             recent data should be used to determine eligibility.&#xD;
&#xD;
               1. Hemoglobin ≥ 8 g/dL&#xD;
&#xD;
               2. Absolute neutrophil count (ANC) ≥ 1.0 x 109/L&#xD;
&#xD;
               3. Platelets ≥ 75 x 109/L&#xD;
&#xD;
               4. Albumin ≥ 2.5 g/dL&#xD;
&#xD;
               5. Total bilirubin ≤ 2 x upper limit of normal (ULN) or direct bilirubin ≤ ULN for&#xD;
                  subjects with total bilirubin levels &gt; 2 x ULN&#xD;
&#xD;
               6. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN&#xD;
                  without liver metastases (or ≤ 5 x ULN if liver metastases are present)&#xD;
&#xD;
               7. Estimated glomerular filtration rate ≥ 30 mL/min/1.73 m2&#xD;
&#xD;
               8. Prothrombin time/international normalized ratio (PT/INR) and partial&#xD;
                  thromboplastin time (PTT) ≤ 2 x ULN (except for subjects receiving&#xD;
                  anticoagulation therapy)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Prohibited Treatment or Therapies:&#xD;
&#xD;
          -  Subject has received systemic immunosuppressive therapy, including systemic&#xD;
             corticosteroids within 14 days prior to first dose of study treatment. Subject using a&#xD;
             physiologic replacement dose of hydrocortisone or its equivalent (defined as up to 30&#xD;
             mg per day of hydrocortisone or up to 10 mg per day of prednisone) is eligible.&#xD;
             Subject who received systemic steroids for asymptomatic central nervous system (CNS)&#xD;
             metastases within 14 days prior to first dose of study treatment is eligible.&#xD;
&#xD;
          -  Subject has received other investigational agents or devices within 28 days prior to&#xD;
             first dose of study treatment.&#xD;
&#xD;
          -  Subject has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to&#xD;
             study day 1 or who has not recovered (i.e., ≤ grade 1 or at baseline) from adverse&#xD;
             event (AE) due to monoclonal antibody (mAb) agents administered more than 4 weeks&#xD;
             earlier.&#xD;
&#xD;
          -  Subject has had prior chemotherapy, targeted small molecule therapy, or radiation&#xD;
             therapy within 2 weeks prior to study day 1 or who has not recovered (i.e., ≤ grade 2&#xD;
             or at baseline) from AEs due to a previously administered agent.&#xD;
&#xD;
        Medical History or Concurrent Disease:&#xD;
&#xD;
          -  Subject has prior severe allergic reaction or intolerance to a monoclonal antibody,&#xD;
             including humanized or chimeric antibodies requiring permanent discontinuation.&#xD;
&#xD;
          -  Subject has known immediate or delayed hypersensitivity, intolerance or&#xD;
             contraindication to any component of study treatment.&#xD;
&#xD;
          -  Subject has an active human immunodeficiency virus (HIV) infection or known active&#xD;
             hepatitis B (HBsAg) or C infection. Subjects with well-controlled HIV infections&#xD;
             (i.e., without detectable viral load) are eligible. For subjects who are negative for&#xD;
             HBsAg, but hepatitis B core antibody (HBcAb) positive, an HBsAg deoxyribonucleic acid&#xD;
             (DNA) test will be performed and if positive, the subject will be excluded. Subjects&#xD;
             with positive serology but negative hepatitis C virus (HCV) ribonucleic acid (RNA)&#xD;
             test results are eligible.&#xD;
&#xD;
          -  Subject has active infection requiring systemic therapy that has not completely&#xD;
             resolved within 14 days prior to first dose of study treatment.&#xD;
&#xD;
          -  Subject has symptomatic central nervous system (CNS) metastases and/or carcinomatous&#xD;
             meningitis. Subject with asymptomatic CNS metastases is eligible.&#xD;
&#xD;
          -  Subject has had a major surgical procedure and has not completely recovered within 28&#xD;
             days prior to the first dose of study treatment.&#xD;
&#xD;
          -  Subject has psychiatric illness or social situations that would preclude study&#xD;
             compliance.&#xD;
&#xD;
          -  Subject has another malignancy for which treatment is required. Subject with&#xD;
             negligible risk of metastasis or death is eligible (e.g., basal or squamous cell skin&#xD;
             cancer, localized prostate cancer treated with curative intent or incidental prostate&#xD;
             cancer T1-T2a, Gleeson ≤ 3 + 4, PSA ≤ 0.5 and who are undergoing active surveillance).&#xD;
&#xD;
          -  Subject has any concurrent disease, infection, or co-morbid condition that interferes&#xD;
             with the ability of the subject to participate in the study, which places the subject&#xD;
             at undue risk or complicates the interpretation of data.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Senior Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Astellas Pharma Global Development, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Indiana University Simon Cancer Center</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan-Kettering Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Abramson Cancer Center University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.clinicaltrials.astellas.com/study/?pid=1650-CL-0201</url>
    <description>Link to results and other applicable study documents on the Astellas Clinical Trials website.</description>
  </link>
  <link>
    <url>https://www.trialsummaries.com/Study/StudyDetails?id=14578&amp;tenant=MT_AST_9011</url>
    <description>Link to plain language summary of the study on the Trial Results Summaries website.</description>
  </link>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>November 29, 2018</study_first_submitted>
  <study_first_submitted_qc>November 29, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 30, 2018</study_first_posted>
  <results_first_submitted>October 12, 2021</results_first_submitted>
  <results_first_submitted_qc>October 12, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">November 10, 2021</results_first_posted>
  <last_update_submitted>November 30, 2021</last_update_submitted>
  <last_update_submitted_qc>November 30, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 2, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Incurable Platinum Refractory Germ Cell Tumors</keyword>
  <keyword>ASP1650</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Neoplasms, Germ Cell and Embryonal</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under &quot;Sponsor Specific Details for Astellas.&quot;</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>April 17, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/81/NCT03760081/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 10, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/81/NCT03760081/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants were enrolled at 3 sites in the United States.</recruitment_details>
      <pre_assignment_details>Adult male participants with incurable platinum refractory germ cell tumors for whom no standard of care treatment exists or who are ineligible to receive available standard of care treatment based on investigator's clinical judgment, who met all inclusion criteria and met none of the exclusion criteria were enrolled in this study. A total of 23 participants entered screening process and out of which 4 participants failed screened process.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>ASP1650, Dose Level 1</title>
          <description>Participants received ASP1650, dose level 1 as intravenous infusion, every two weeks (Q2W) starting on Cycle 1 Day 1 (C1D1) for up to a maximum of 12 cycles, or a until study discontinuation criteria was met, whichever occurred earlier. Duration of each treatment cycle was 14 days.</description>
        </group>
        <group group_id="P2">
          <title>ASP1650, Dose Level 2</title>
          <description>Participants received ASP1650, dose level 2 as intravenous infusion, Q2W starting on C1D1 for up to a maximum of 12 cycles or until a study discontinuation criteria was met, whichever occurred earlier. Duration of each treatment cycle was 14 days.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="13"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="12"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Miscellaneous</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Progressive Disease</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Safety analysis set (SAF) population which included all enrolled participants who took at least 1 dose of ASP1650.</population>
      <group_list>
        <group group_id="B1">
          <title>ASP1650, Dose Level 1</title>
          <description>Participants received ASP1650, dose level 1 as intravenous infusion, Q2W starting on C1D1 for up to a maximum of 12 cycles, or until a study discontinuation criteria was met, whichever occurred earlier. Duration of each treatment cycle was 14 days.</description>
        </group>
        <group group_id="B2">
          <title>ASP1650, Dose Level 2</title>
          <description>Participants received ASP1650, dose level 2 as intravenous infusion, Q2W starting on C1D1 for up to a maximum of 12 cycles or until a study discontinuation criteria was met, whichever occurred earlier. Duration of each treatment cycle was 14 days.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="6"/>
            <count group_id="B2" value="13"/>
            <count group_id="B3" value="19"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="37.8" spread="10.6"/>
                    <measurement group_id="B2" value="36.9" spread="12.2"/>
                    <measurement group_id="B3" value="37.2" spread="11.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Recommended Phase 2 Dose (RP2D) of ASP1650</title>
        <description>The RP2D was determined via dose limiting toxicity (DLT) assessment by dose evaluation committee (DEC). DLT was evaluated according to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTCAE) version 5.0.</description>
        <time_frame>Up to 28 days</time_frame>
        <population>SAF population</population>
        <group_list>
          <group group_id="O1">
            <title>ASP1650</title>
            <description>Participants received ASP1650, dose level 1 or dose level 2 as intravenous infusion, Q2W starting on C1D1 for up to a maximum of 12 cycles, or until a study discontinuation criteria was met, whichever occurred earlier. Duration of each treatment cycle was 14 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Recommended Phase 2 Dose (RP2D) of ASP1650</title>
          <description>The RP2D was determined via dose limiting toxicity (DLT) assessment by dose evaluation committee (DEC). DLT was evaluated according to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTCAE) version 5.0.</description>
          <population>SAF population</population>
          <units>Milligram per meter square (mg/m^2)</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1500"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Confirmed Objective Response by Modified RECIST v1.1</title>
        <description>Confirmed objective response was defined as the confirmed completed response (CR) or confirmed partial response (PR), as confirmed by investigator based on modified Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Per modified RECIST v1.1, CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to &lt;10 mm. Both Alpha-Fetoprotein (AFP) and Beta Human Chorionic Gonadotropin (beta-HCG) values were below the ULN. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. No increase ≥ 50% in 2 samples at least 1 week apart compared to nadir values for both AFP and beta-HCG.</description>
        <time_frame>From randomization until confirmed CR or confirmed PR, whichever occurred first (up to 26.57 weeks)</time_frame>
        <population>Full analysis set (FAS) population which included all enrolled participants.</population>
        <group_list>
          <group group_id="O1">
            <title>ASP1650, Dose Level 1</title>
            <description>Participants received ASP1650, dose level 1 as intravenous infusion, Q2W starting on C1D1 for up to a maximum of 12 cycles, or until a study discontinuation criteria was met, whichever occurred earlier. Duration of each treatment cycle was 14 days.</description>
          </group>
          <group group_id="O2">
            <title>ASP1650, Dose Level 2</title>
            <description>Participants received ASP1650, dose level 2 as intravenous infusion, Q2W starting on C1D1 for up to a maximum of 12 cycles or until a study discontinuation criteria was met, whichever occurred earlier. Duration of each treatment cycle was 14 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Confirmed Objective Response by Modified RECIST v1.1</title>
          <description>Confirmed objective response was defined as the confirmed completed response (CR) or confirmed partial response (PR), as confirmed by investigator based on modified Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Per modified RECIST v1.1, CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to &lt;10 mm. Both Alpha-Fetoprotein (AFP) and Beta Human Chorionic Gonadotropin (beta-HCG) values were below the ULN. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. No increase ≥ 50% in 2 samples at least 1 week apart compared to nadir values for both AFP and beta-HCG.</description>
          <population>Full analysis set (FAS) population which included all enrolled participants.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="39.3"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="20.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Confirmed Objective Response by RECIST v1.1</title>
        <description>Confirmed objective response was defined as the confirmed CR or PR, as confirmed by investigator based on RECIST v1.1. Per RECIST v1.1, CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to &lt;10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.</description>
        <time_frame>From randomization until confirmed CR or confirmed PR, whichever occurred first (up to 26.57 weeks)</time_frame>
        <population>FAS population</population>
        <group_list>
          <group group_id="O1">
            <title>ASP1650, Dose Level 1</title>
            <description>Participants received ASP1650, dose level 1 as intravenous infusion, Q2W starting on C1D1 for up to a maximum of 12 cycles, or until a study discontinuation criteria was met, whichever occurred earlier. Duration of each treatment cycle was 14 days.</description>
          </group>
          <group group_id="O2">
            <title>ASP1650, Dose Level 2</title>
            <description>Participants received ASP1650, dose level 2 as intravenous infusion, Q2W starting on C1D1 for up to a maximum of 12 cycles or until a study discontinuation criteria was met, whichever occurred earlier. Duration of each treatment cycle was 14 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Confirmed Objective Response by RECIST v1.1</title>
          <description>Confirmed objective response was defined as the confirmed CR or PR, as confirmed by investigator based on RECIST v1.1. Per RECIST v1.1, CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to &lt;10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.</description>
          <population>FAS population</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="39.3"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="20.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Clinical Benefit by Modified RECIST v1.1 and RECIST v1.1</title>
        <description>Clinical benefit: defined as best overall response of confirmed CR, confirmed PR, or durable stable disease (SD) as confirmed by investigator based on modified RECIST v1.1 and RECIST v1.1. Per RECIST v1.1 and modified RECIST V1.1, CR: disappearance of all target lesions. Any pathological lymph nodes(whether target or non-target) must have reduction in short axis to &lt;10 mm. PR:at least a 30% decrease in sum of diameters of target lesions, taking as reference baseline sum diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference smallest sum diameters while on study. Durable SD: SD maintained for at least 12 weeks. Additionally, per modified RECIST v1.1, CR also included AFP and beta-HCG values below ULN. PR also included no increase ≥ 50% in 2 samples at least 1 week apart compared to nadir values both for AFP and beta-HCG.</description>
        <time_frame>From randomization until confirmed CR, confirmed PR, or durable SD whichever occurred first (up to 26.57 weeks)</time_frame>
        <population>FAS population</population>
        <group_list>
          <group group_id="O1">
            <title>ASP1650, Dose Level 1</title>
            <description>Participants received ASP1650, dose level 1 as intravenous infusion, Q2W starting on C1D1 for up to a maximum of 12 cycles, or until a study discontinuation criteria was met, whichever occurred earlier. Duration of each treatment cycle was 14 days.</description>
          </group>
          <group group_id="O2">
            <title>ASP1650, Dose Level 2</title>
            <description>Participants received ASP1650, dose level 2 as intravenous infusion, Q2W starting on C1D1 for up to a maximum of 12 cycles or until a study discontinuation criteria was met, whichever occurred earlier. Duration of each treatment cycle was 14 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Clinical Benefit by Modified RECIST v1.1 and RECIST v1.1</title>
          <description>Clinical benefit: defined as best overall response of confirmed CR, confirmed PR, or durable stable disease (SD) as confirmed by investigator based on modified RECIST v1.1 and RECIST v1.1. Per RECIST v1.1 and modified RECIST V1.1, CR: disappearance of all target lesions. Any pathological lymph nodes(whether target or non-target) must have reduction in short axis to &lt;10 mm. PR:at least a 30% decrease in sum of diameters of target lesions, taking as reference baseline sum diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference smallest sum diameters while on study. Durable SD: SD maintained for at least 12 weeks. Additionally, per modified RECIST v1.1, CR also included AFP and beta-HCG values below ULN. PR also included no increase ≥ 50% in 2 samples at least 1 week apart compared to nadir values both for AFP and beta-HCG.</description>
          <population>FAS population</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Modified RECIST v1.1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="39.3"/>
                    <measurement group_id="O2" value="7.7" lower_limit="0.4" upper_limit="31.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RECIST v1.1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="39.3"/>
                    <measurement group_id="O2" value="7.7" lower_limit="0.4" upper_limit="31.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Response (DOR) by Modified RECIST v1.1 and RECIST v1.1 for Dose Level 2</title>
        <description>DOR was defined as the time from the date of the first confirmed response CR or confirmed PR (whichever was first recorded) as confirmed by investigator based on modified RECIST 1.1 and RECIST v1.1 to the date of disease progression or date of censoring, whichever was earlier. If a participant had not progressed, participant was censored at the date of last disease assessment or at the date of first confirmed CR/PR if no post-baseline disease assessment was available. DOR (in days) was calculated as: (Date of documented progressive disease [PD], death, or censoring) minus (Date of the first CR/PR which was subsequently confirmed) +1. Duration of response was planned to summarized only for participants receiving dose level 2 in phase 2.</description>
        <time_frame>From randomization until confirmed CR or confirmed PR whichever occurred first (up to 26.57 weeks)</time_frame>
        <population>DOR was not analyzed since no participants had confirmed response of CR or PR in the study.</population>
        <group_list>
          <group group_id="O1">
            <title>ASP1650, Dose Level 2</title>
            <description>Participants received ASP1650, dose level 2 as intravenous infusion, Q2W starting on C1D1 for up to a maximum of 12 cycles or until a study discontinuation criteria was met, whichever occurred earlier. Duration of each treatment cycle was 14 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Response (DOR) by Modified RECIST v1.1 and RECIST v1.1 for Dose Level 2</title>
          <description>DOR was defined as the time from the date of the first confirmed response CR or confirmed PR (whichever was first recorded) as confirmed by investigator based on modified RECIST 1.1 and RECIST v1.1 to the date of disease progression or date of censoring, whichever was earlier. If a participant had not progressed, participant was censored at the date of last disease assessment or at the date of first confirmed CR/PR if no post-baseline disease assessment was available. DOR (in days) was calculated as: (Date of documented progressive disease [PD], death, or censoring) minus (Date of the first CR/PR which was subsequently confirmed) +1. Duration of response was planned to summarized only for participants receiving dose level 2 in phase 2.</description>
          <population>DOR was not analyzed since no participants had confirmed response of CR or PR in the study.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Modified RECIST V1.1</title>
            </class>
            <class>
              <title>RECIST V1.1</title>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Progression-Free Survival (PFS) by Modified RECIST v1.1 and RECIST v1.1 for Dose Level 2</title>
        <description>PFS was defined as the time from the date of first dose until the date of disease progression, or until death due to any cause. If a participant had neither progressed nor died, the participant was censored at the date of last disease as confirmed by investigator based on modified RECIST v1.1 and RECIST v1.1. The distribution of PFS was planned to be summarized only for participants receiving dose level 2 using Kaplan-Meier methodology. Per modified RECIST v1.1 and RECIST v1.1, Progressive disease (PD): appearance of one or more new lesions or at least a 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study (this includes the baseline sum if that is the smallest on study). Also, the sum must be an absolute increase of at least 5 mm. Additionally per modified RECIST v1.1, PD was increase ≥ 50% in serum tumor markers AFP or beta-hCG in 2 samples at least 1 week apart compared to nadir values.</description>
        <time_frame>From the date of first dose until the date of disease progression, or until death due to any cause (up to 26.57 weeks)</time_frame>
        <population>FAS population</population>
        <group_list>
          <group group_id="O1">
            <title>ASP1650, Dose Level 2</title>
            <description>Participants received ASP1650, dose level 2 as intravenous infusion, Q2W starting on C1D1 for up to a maximum of 12 cycles or until a study discontinuation criteria was met, whichever occurred earlier. Duration of each treatment cycle was 14 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Progression-Free Survival (PFS) by Modified RECIST v1.1 and RECIST v1.1 for Dose Level 2</title>
          <description>PFS was defined as the time from the date of first dose until the date of disease progression, or until death due to any cause. If a participant had neither progressed nor died, the participant was censored at the date of last disease as confirmed by investigator based on modified RECIST v1.1 and RECIST v1.1. The distribution of PFS was planned to be summarized only for participants receiving dose level 2 using Kaplan-Meier methodology. Per modified RECIST v1.1 and RECIST v1.1, Progressive disease (PD): appearance of one or more new lesions or at least a 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study (this includes the baseline sum if that is the smallest on study). Also, the sum must be an absolute increase of at least 5 mm. Additionally per modified RECIST v1.1, PD was increase ≥ 50% in serum tumor markers AFP or beta-hCG in 2 samples at least 1 week apart compared to nadir values.</description>
          <population>FAS population</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Modified RECIST V1.1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.18" lower_limit="0.92" upper_limit="1.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RECIST V1.1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.45" lower_limit="0.92" upper_limit="2.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Adverse Events (AEs)</title>
        <description>An AE was defined as any untoward medical occurrence in a participant administered with an Investigational Product (IP) which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign including abnormal laboratory finding/test result or other safety assessment, symptom, or disease temporally associated with use of IP whether or not considered related to IP. A treatment-emergent adverse event (TEAE) was defined as an AE with onset at any time from first dosing until last scheduled procedure. AEs were considered serious (SAEs) if AE resulted in death, was life-threatening, resulted in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, resulted in congenital anomaly, birth defect, or required inpatient hospitalization or led to prolongation of hospitalization.</description>
        <time_frame>From first dose of study drug up to 30 days after the last dose of study drug (up to 41.14 weeks)</time_frame>
        <population>SAF population</population>
        <group_list>
          <group group_id="O1">
            <title>ASP1650, Dose Level 1</title>
            <description>Participants received ASP1650, dose level 1 as intravenous infusion, Q2W starting on C1D1 for up to a maximum of 12 cycles, or until a study discontinuation criteria was met, whichever occurred earlier. Duration of each treatment cycle was 14 days.</description>
          </group>
          <group group_id="O2">
            <title>ASP1650, Dose Level 2</title>
            <description>Participants received ASP1650, dose level 2 as intravenous infusion, Q2W starting on C1D1 for up to a maximum of 12 cycles or until a study discontinuation criteria was met, whichever occurred earlier. Duration of each treatment cycle was 14 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Adverse Events (AEs)</title>
          <description>An AE was defined as any untoward medical occurrence in a participant administered with an Investigational Product (IP) which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign including abnormal laboratory finding/test result or other safety assessment, symptom, or disease temporally associated with use of IP whether or not considered related to IP. A treatment-emergent adverse event (TEAE) was defined as an AE with onset at any time from first dosing until last scheduled procedure. AEs were considered serious (SAEs) if AE resulted in death, was life-threatening, resulted in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, resulted in congenital anomaly, birth defect, or required inpatient hospitalization or led to prolongation of hospitalization.</description>
          <population>SAF population</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Drug-Related TEAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serious TEAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Drug-Related Serious TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TEAE Leading to Death</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Drug-Related TEAE Leading to Death</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TEAE Leading to Withdrawal of Treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Drug-Related TEAE Leading to Withdrawal of Treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Death</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Shifts From Baseline to Post Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG PS)</title>
        <description>Number of participants with shifts from baseline to post baseline in ECOG PS levels were reported. ECOG has 6 levels (0-5). Level 0 is fully active, able to carry on all pre-disease performance without restriction; Level 1 is restricted in physically strenuous activity but ambulatory ad able to carry out work of a light or sedentary nature, e.g. light house work, office work; Level 2 is ambulatory and capable of all self care but unable to carry out any work activities; up and about more than 50% of waking hours; Level 3 is capable of only limited self care; confined to bed or chair more than 50% of waking hours; Level 4 is completely disabled; cannot carry on any self care; totally confined to bed or chair); and Level 5 is dead.</description>
        <time_frame>Baseline, C2D1, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1, C9D1, C10D1, C11D1, C12D1 (Duration of each treatment cycle was 14 days)</time_frame>
        <population>SAF population with available data at each time point.</population>
        <group_list>
          <group group_id="O1">
            <title>ASP1650, Dose Level 1</title>
            <description>Participants received ASP1650, dose level 1 as intravenous infusion, Q2W starting on C1D1 for up to a maximum of 12 cycles, or until a study discontinuation criteria was met, whichever occurred earlier. Duration of each treatment cycle was 14 days.</description>
          </group>
          <group group_id="O2">
            <title>ASP1650, Dose Level 2</title>
            <description>Participants received ASP1650, dose level 2 as intravenous infusion, Q2W starting on C1D1 for up to a maximum of 12 cycles or until a study discontinuation criteria was met, whichever occurred earlier. Duration of each treatment cycle was 14 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Shifts From Baseline to Post Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG PS)</title>
          <description>Number of participants with shifts from baseline to post baseline in ECOG PS levels were reported. ECOG has 6 levels (0-5). Level 0 is fully active, able to carry on all pre-disease performance without restriction; Level 1 is restricted in physically strenuous activity but ambulatory ad able to carry out work of a light or sedentary nature, e.g. light house work, office work; Level 2 is ambulatory and capable of all self care but unable to carry out any work activities; up and about more than 50% of waking hours; Level 3 is capable of only limited self care; confined to bed or chair more than 50% of waking hours; Level 4 is completely disabled; cannot carry on any self care; totally confined to bed or chair); and Level 5 is dead.</description>
          <population>SAF population with available data at each time point.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ECOG PS : 0 (baseline) to 0 (C2D1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ECOG PS : 0 (baseline) to 1 (C2D1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ECOG PS : 1 (baseline) to 0 (C2D1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ECOG PS : 1 (baseline) to 1 (C2D1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ECOG PS : 2 (baseline) to 1 (C2D1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ECOG PS : 0 (baseline) to 0 (C3D1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ECOG PS : 0 (baseline) to 1 (C3D1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ECOG PS : 1 (baseline) to 0 (C3D1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ECOG PS : 1 (baseline) to 1 (C3D1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ECOG PS : 0 (baseline) to 0 (C4D1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ECOG PS : 1 (baseline) to 1 (C4D1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ECOG PS : 0 (baseline) to 0 (C5D1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ECOG PS : 1 (baseline) to 0 (C5D1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ECOG PS : 0 (baseline) to 0 (C6D1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ECOG PS : 1 (baseline) to 1 (C6D1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ECOG PS : 0 (baseline) to 0 (C7D1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ECOG PS : 1 (baseline) to 1 (C7D1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ECOG PS : 0 (baseline) to 0 (C8D1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ECOG PS : 1 (baseline) to 1 (C8D1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ECOG PS : 0 (baseline) to 0 (C9D1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ECOG PS : 1 (baseline) to 1 (C9D1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ECOG PS : 1 (baseline) to 1 (C10D1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ECOG PS : 1 (baseline) to 1 (C11D1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ECOG PS : 1 (baseline) to 1 (C12D1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Serum Beta Human Chorionic Gonadotropin (βhCG)</title>
        <description>Blood was drawn for the measurement of serum βhCG at day 1 of every cycle (14 day cycle) to align with imaging assessment until the participant develops radiological disease progression per RECIST v1.1 evaluation or starts other systemic anticancer treatment. To evaluate the effect of ASP1650 on changes in serum βhCG, disease response was derived for participants with elevated serum tumor markers at baseline using CR, PR and SD.</description>
        <time_frame>Baseline, Cycle 2 Day 1 (C2D1), C3D1, C4D1, C5D1, C6D1, C7D1, C8D1, C9D1, C10D1, C11D1, C12D1 (duration of each cycle was 14 days)</time_frame>
        <population>FAS population with available data at each time point.</population>
        <group_list>
          <group group_id="O1">
            <title>ASP1650, Dose Level 1</title>
            <description>Participants received ASP1650, dose level 1 as intravenous infusion, Q2W starting on C1D1 for up to a maximum of 12 cycles, or until a study discontinuation criteria was met, whichever occurred earlier. Duration of each treatment cycle was 14 days.</description>
          </group>
          <group group_id="O2">
            <title>ASP1650, Dose Level 2</title>
            <description>Participants received ASP1650, dose level 2 as intravenous infusion, Q2W starting on C1D1 for up to a maximum of 12 cycles or until a study discontinuation criteria was met, whichever occurred earlier. Duration of each treatment cycle was 14 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Serum Beta Human Chorionic Gonadotropin (βhCG)</title>
          <description>Blood was drawn for the measurement of serum βhCG at day 1 of every cycle (14 day cycle) to align with imaging assessment until the participant develops radiological disease progression per RECIST v1.1 evaluation or starts other systemic anticancer treatment. To evaluate the effect of ASP1650 on changes in serum βhCG, disease response was derived for participants with elevated serum tumor markers at baseline using CR, PR and SD.</description>
          <population>FAS population with available data at each time point.</population>
          <units>International unit per liter (IU/L)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32641.67" spread="70670.15"/>
                    <measurement group_id="O2" value="1198.00" spread="2293.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at C2D1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13847.50" spread="28555.07"/>
                    <measurement group_id="O2" value="2573.42" spread="4680.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at C3D1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="105.50" spread="149.20"/>
                    <measurement group_id="O2" value="-0.83" spread="2.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at C4D1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="NA">Since only one participant was available for analysis at C4D1, standard deviation could not be calculated.</measurement>
                    <measurement group_id="O2" value="-1.25" spread="2.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at C5D1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="NA">Since only one participant was available for analysis at C5D1, standard deviation could not be calculated.</measurement>
                    <measurement group_id="O2" value="-2.00" spread="3.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at C6D1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="NA">Since only one participant was available for analysis at C6D1, standard deviation could not be calculated.</measurement>
                    <measurement group_id="O2" value="-1.00" spread="1.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at C7D1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="NA">Since only one participant was available for analysis at C7D1, standard deviation could not be calculated.</measurement>
                    <measurement group_id="O2" value="1.00" spread="NA">Since only one participant was available for analysis at C7D1, standard deviation could not be calculated.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at C8D1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="NA">Since only one participant was available for analysis at C8D1, standard deviation could not be calculated.</measurement>
                    <measurement group_id="O2" value="2.00" spread="NA">Since only one participant was available for analysis at C8D1, standard deviation could not be calculated.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at C9D1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="NA">Since only one participant was available for analysis at C9D1, standard deviation could not be calculated.</measurement>
                    <measurement group_id="O2" value="3.00" spread="NA">Since only one participant was available for analysis at C9D1, standard deviation could not be calculated.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at C10D1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-9.00" spread="NA">Since only one participant was available for analysis at C10D1, standard deviation could not be calculated.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at C11D1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="12.00" spread="NA">Since only one participant was available for analysis at C11D1, standard deviation could not be calculated.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at C12D1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="85.00" spread="NA">Since only one participant was available for analysis at C12D1, standard deviation could not be calculated.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Serum Alpha-Fetoprotein (AFP)</title>
        <description>Blood was drawn for the measurement of serum AFP at day 1 of every cycle (14 day cycle) to align with imaging assessment until the participant develops radiological disease progression per RECIST v1.1 evaluation or starts other systemic anticancer treatment. To evaluate the effect of ASP1650 on changes in serum AFP, disease response was derived for participants with elevated serum tumor markers at baseline using CR, PR and SD.</description>
        <time_frame>Baseline, C2D1, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1, C9D1, C10D1, C11D1, C12D1 (duration of each cycle was 14 days)</time_frame>
        <population>FAS population with available data at each time point.</population>
        <group_list>
          <group group_id="O1">
            <title>ASP1650, Dose Level 1</title>
            <description>Participants received ASP1650, dose level 1 as intravenous infusion, Q2W starting on C1D1 for up to a maximum of 12 cycles, or until a study discontinuation criteria was met, whichever occurred earlier. Duration of each treatment cycle was 14 days.</description>
          </group>
          <group group_id="O2">
            <title>ASP1650, Dose Level 2</title>
            <description>Participants received ASP1650, dose level 2 as intravenous infusion, Q2W starting on C1D1 for up to a maximum of 12 cycles or until a study discontinuation criteria was met, whichever occurred earlier. Duration of each treatment cycle was 14 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Serum Alpha-Fetoprotein (AFP)</title>
          <description>Blood was drawn for the measurement of serum AFP at day 1 of every cycle (14 day cycle) to align with imaging assessment until the participant develops radiological disease progression per RECIST v1.1 evaluation or starts other systemic anticancer treatment. To evaluate the effect of ASP1650 on changes in serum AFP, disease response was derived for participants with elevated serum tumor markers at baseline using CR, PR and SD.</description>
          <population>FAS population with available data at each time point.</population>
          <units>Microgram per liter (ug/L)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="948.65" spread="2065.59"/>
                    <measurement group_id="O2" value="7116.52" spread="14580.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at C2D1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-84.03" spread="257.70"/>
                    <measurement group_id="O2" value="2504.03" spread="6139.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at C3D1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.00" spread="11.31"/>
                    <measurement group_id="O2" value="5404.50" spread="11064.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at C4D1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.00" spread="NA">Since only one participant was available for analysis at C4D1, standard deviation could not be calculated.</measurement>
                    <measurement group_id="O2" value="2592.25" spread="4354.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at C5D1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.00" spread="NA">Since only one participant was available for analysis at C5D1, standard deviation could not be calculated.</measurement>
                    <measurement group_id="O2" value="762.00" spread="1101.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at C6D1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.00" spread="NA">Since only one participant was available for analysis at C6D1, standard deviation could not be calculated.</measurement>
                    <measurement group_id="O2" value="1343.00" spread="1650.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at C7D1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94.00" spread="NA">Since only one participant was available for analysis at C7D1, standard deviation could not be calculated.</measurement>
                    <measurement group_id="O2" value="118.00" spread="NA">Since only one participant was available for analysis at C7D1, standard deviation could not be calculated.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at C8D1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="138.00" spread="NA">Since only one participant was available for analysis at C8D1, standard deviation could not be calculated.</measurement>
                    <measurement group_id="O2" value="99.00" spread="NA">Since only one participant was available for analysis at C8D1, standard deviation could not be calculated.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at C9D1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.00" spread="NA">Since only one participant was available for analysis at C9D1, standard deviation could not be calculated.</measurement>
                    <measurement group_id="O2" value="-27.00" spread="NA">Since only one participant was available for analysis at C9D1, standard deviation could not be calculated.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at C10D1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-454.00" spread="NA">Since only one participant was available for analysis at C10D1, standard deviation could not be calculated.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at C11D1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-579.10" spread="NA">Since only one participant was available for analysis at C11D1, standard deviation could not be calculated.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at C12D1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-598.90" spread="NA">Since only one participant was available for analysis at C12D1, standard deviation could not be calculated.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacokinetics (PK) of ASP1650 in Plasma: Area Under the Concentration-Time Curve Over 336 Hours (AUC336)</title>
        <description>AUC336 was derived from the Pharmacokinetic (PK) plasma samples collected. Duration of each cycle was 14 days.</description>
        <time_frame>Dose Level 1 - CID1, C3D1: predose, 1.5 h after start of infusion, immediately after end of infusion, 0.5, 1.5, 3, 6, 24, 48, 72 h after end of infusion; Dose Level 2 - C1D1, C3D1: predose, immediately after end of infusion</time_frame>
        <population>Pharmacokinetic analysis set (PKAS) population with available data at each time point. PKAS population included all enrolled participants who took at least 1 dose of ASP1650 and for whom at least 1 ASP1650 concentration measurement was available.</population>
        <group_list>
          <group group_id="O1">
            <title>ASP1650, Dose Level 1</title>
            <description>Participants received ASP1650, dose level 1 as intravenous infusion, Q2W starting on C1D1 for up to a maximum of 12 cycles, or until a study discontinuation criteria was met, whichever occurred earlier. Duration of each treatment cycle was 14 days.</description>
          </group>
          <group group_id="O2">
            <title>ASP1650, Dose Level 2</title>
            <description>Participants received ASP1650, dose level 2 as intravenous infusion, Q2W starting on C1D1 for up to a maximum of 12 cycles or until a study discontinuation criteria was met, whichever occurred earlier. Duration of each treatment cycle was 14 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics (PK) of ASP1650 in Plasma: Area Under the Concentration-Time Curve Over 336 Hours (AUC336)</title>
          <description>AUC336 was derived from the Pharmacokinetic (PK) plasma samples collected. Duration of each cycle was 14 days.</description>
          <population>Pharmacokinetic analysis set (PKAS) population with available data at each time point. PKAS population included all enrolled participants who took at least 1 dose of ASP1650 and for whom at least 1 ASP1650 concentration measurement was available.</population>
          <units>microgram*hour per milliliter (ug*h/mL)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>C1D1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73000" spread="25600"/>
                    <measurement group_id="O2" value="112000" spread="28300"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C3D1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="156000" spread="NA">Since only one participant was available for analysis at C3D1, standard deviation could not be calculated.</measurement>
                    <measurement group_id="O2" value="137000" spread="14800"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacokinetics (PK) of ASP1650 in Plasma: Maximum Concentration (Cmax)</title>
        <description>Cmax was derived from the PK plasma samples collected. Duration of each cycle was 14 days.</description>
        <time_frame>Dose Level 1-CID1, C3D1: predose, 1.5 h after start of infusion, immediately after end of infusion, 0.5, 1.5, 3, 6, 24, 48, 72 h after end of infusion; Dose Level 2-C1D1, C3D1: predose, immediately after end of infusion</time_frame>
        <population>PKAS population with available data at each time point.</population>
        <group_list>
          <group group_id="O1">
            <title>ASP1650, Dose Level 1</title>
            <description>Participants received ASP1650, dose level 1 as intravenous infusion, Q2W starting on C1D1 for up to a maximum of 12 cycles, or until a study discontinuation criteria was met, whichever occurred earlier. Duration of each treatment cycle was 14 days.</description>
          </group>
          <group group_id="O2">
            <title>ASP1650, Dose Level 2</title>
            <description>Participants received ASP1650, dose level 2 as intravenous infusion, Q2W starting on C1D1 for up to a maximum of 12 cycles or until a study discontinuation criteria was met, whichever occurred earlier. Duration of each treatment cycle was 14 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics (PK) of ASP1650 in Plasma: Maximum Concentration (Cmax)</title>
          <description>Cmax was derived from the PK plasma samples collected. Duration of each cycle was 14 days.</description>
          <population>PKAS population with available data at each time point.</population>
          <units>microgram per milliliter (ug/mL)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>C1D1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="757" spread="245"/>
                    <measurement group_id="O2" value="1080" spread="277"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C3D1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="904" spread="NA">Since very few participants were available for analysis at C3D1, standard deviation could not be calculated.</measurement>
                    <measurement group_id="O2" value="1300" spread="227"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacokinetics (PK) of ASP1650 in Plasma: Time to Maximum Concentration (Tmax)</title>
        <description>Tmax was derived from the PK plasma samples collected. Duration of each cycle was 14 days.</description>
        <time_frame>Dose Level 1- CID1, C3D1: predose, 1.5 h after start of infusion, immediately after end of infusion, 0.5, 1.5, 3, 6, 24, 48, 72 h after end of infusion; Dose Level 2- C1D1, C3D1: predose, immediately after end of infusion</time_frame>
        <population>PKAS analysis with available data at each time point.</population>
        <group_list>
          <group group_id="O1">
            <title>ASP1650, Dose Level 1</title>
            <description>Participants received ASP1650, dose level 1 as intravenous infusion, Q2W starting on C1D1 for up to a maximum of 12 cycles, or until a study discontinuation criteria was met, whichever occurred earlier. Duration of each treatment cycle was 14 days.</description>
          </group>
          <group group_id="O2">
            <title>ASP1650, Dose Level 2</title>
            <description>Participants received ASP1650, dose level 2 as intravenous infusion, Q2W starting on C1D1 for up to a maximum of 12 cycles or until a study discontinuation criteria was met, whichever occurred earlier. Duration of each treatment cycle was 14 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics (PK) of ASP1650 in Plasma: Time to Maximum Concentration (Tmax)</title>
          <description>Tmax was derived from the PK plasma samples collected. Duration of each cycle was 14 days.</description>
          <population>PKAS analysis with available data at each time point.</population>
          <units>hour</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>C1D1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.03" lower_limit="2.00" upper_limit="2.50"/>
                    <measurement group_id="O2" value="4.50" lower_limit="3.08" upper_limit="9.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C3D1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.38" lower_limit="2.00" upper_limit="4.75"/>
                    <measurement group_id="O2" value="3.50" lower_limit="3.05" upper_limit="4.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacokinetics (PK) of ASP1650 in Plasma: Concentration Immediately Prior to Dosing at Multiple Dosing (Ctrough)</title>
        <description>Ctrough was derived from the PK plasma samples collected. Duration of each cycle was 14 days.</description>
        <time_frame>C2D1,C3D1,C4D1,C5D1,C6D1,C7D1,C8D1,C9D1,C10D1,C11D1,C12D1:predose,1.5 h post start of infusion, immediately post end of infusion,0.5,1.5,3,6,24,48,72 h post end of infusion for Dose Level 1, and predose, immediately post end of infusion for Dose Level 2</time_frame>
        <population>PKAS population with available data at each time point.</population>
        <group_list>
          <group group_id="O1">
            <title>ASP1650, Dose Level 1</title>
            <description>Participants received ASP1650, dose level 1 as intravenous infusion, Q2W starting on C1D1 for up to a maximum of 12 cycles, or until a study discontinuation criteria was met, whichever occurred earlier. Duration of each treatment cycle was 14 days.</description>
          </group>
          <group group_id="O2">
            <title>ASP1650, Dose Level 2</title>
            <description>Participants received ASP1650, dose level 2 as intravenous infusion, Q2W starting on C1D1 for up to a maximum of 12 cycles or until a study discontinuation criteria was met, whichever occurred earlier. Duration of each treatment cycle was 14 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics (PK) of ASP1650 in Plasma: Concentration Immediately Prior to Dosing at Multiple Dosing (Ctrough)</title>
          <description>Ctrough was derived from the PK plasma samples collected. Duration of each cycle was 14 days.</description>
          <population>PKAS population with available data at each time point.</population>
          <units>ug/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>C2D1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74.55" spread="62.79"/>
                    <measurement group_id="O2" value="111.64" spread="44.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C3D1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="238" spread="NA">Since only one participant was available for analysis at C3D1, standard deviation could not be calculated.</measurement>
                    <measurement group_id="O2" value="163.6" spread="39.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C4D1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="290" spread="NA">Since only one participant was available for analysis at C4D1, standard deviation could not be calculated.</measurement>
                    <measurement group_id="O2" value="184.5" spread="56.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C5D1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="343" spread="NA">Since only one participant was available for analysis at C5D1, standard deviation could not be calculated.</measurement>
                    <measurement group_id="O2" value="186.33" spread="39.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C6D1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="306" spread="NA">Since only one participant was available for analysis at C6D1, standard deviation could not be calculated.</measurement>
                    <measurement group_id="O2" value="232.5" spread="20.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C7D1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="317" spread="NA">Since only one participant was available for analysis at C7D1, standard deviation could not be calculated.</measurement>
                    <measurement group_id="O2" value="225" spread="NA">Since only one participant was available for analysis at C7D1, standard deviation could not be calculated.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C8D1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="329" spread="NA">Since only one participant was available for analysis at C8D1, standard deviation could not be calculated.</measurement>
                    <measurement group_id="O2" value="200" spread="NA">Since only one participant was available for analysis at C8D1, standard deviation could not be calculated.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C9D1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="318" spread="NA">Since only one participant was available for analysis at C9D1, standard deviation could not be calculated.</measurement>
                    <measurement group_id="O2" value="296" spread="NA">Since only one participant was available for analysis at C9D1, standard deviation could not be calculated.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C10D1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="223" spread="NA">Since only one participant was available for analysis at C10D1, standard deviation could not be calculated.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C11D1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="21.3" spread="NA">Since only one participant was available for analysis at C11D1, standard deviation could not be calculated.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C12D1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="82.4" spread="NA">Since only one participant was available for analysis at C12D1, standard deviation could not be calculated.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From first dose of study drug up to 30 days after the last dose of study drug (up to 41.14 weeks)</time_frame>
      <group_list>
        <group group_id="E1">
          <title>ASP1650, Dose Level 1</title>
          <description>Participants received ASP1650, dose level 1 as intravenous infusion, Q2W starting on C1D1 for up to a maximum of 12 cycles, or until a study discontinuation criteria was met, whichever occurred earlier. Duration of each treatment cycle was 14 days.</description>
        </group>
        <group group_id="E2">
          <title>ASP1650, Dose Level 2</title>
          <description>Participants received ASP1650, dose level 2 as intravenous infusion, Q2W starting on C1D1 for up to a maximum of 12 cycles or until a study discontinuation criteria was met, whichever occurred earlier. Duration of each treatment cycle was 14 days.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA v23.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Gastrointestinal fistula</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Upper gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Abdominal infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Malignant neoplasm progression</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Hemiparesis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Spinal cord compression</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Urinary tract obstruction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA v23.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="7" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood bilirubin increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Blood testosterone decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Dysuria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Oedema genital</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Dyspnoea exertional</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Eczema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data. Sponsor must receive a site's manuscript prior to publication for review and comment as specified in the Investigator Agreement.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Clinical Trial Disclosure</name_or_title>
      <organization>Astellas Pharma Global Development, Inc.</organization>
      <phone>800-888-7704</phone>
      <email>astellas.resultsdisclosure@astellas.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03760081
org study id: 1650-CL-0201
nct id: NCT03760081
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study was to establish the recommended phase 2 dose (RP2D) of ASP1650
      (Safety Lead-in Phase), as well as, evaluate the efficacy of ASP1650 as measured by confirmed
      objective response rate (ORR) (phase 2) in participants with incurable platinum refractory
      germ cell tumors.

      This study also evaluated the following efficacy measures for confirmed objective response
      rate (ORR); clinical benefit rate (CBR); duration of response (DOR); and progression-free
      survival (PFS); as well as safety and tolerability; the effect of ASP1650 on changes in serum
      beta human chorionic gonadotropin (βhCG) and alpha-fetoprotein (AFP); and the
      pharmacokinetics of ASP1650.
The study consisted of 2 phases: Safety Lead-in phase and phase 2. 19 participants were
      enrolled in both phases.

      The Safety Lead-in phase of this study was to establish the tolerability of RP2D. The RP2D
      determination was based on at least 6 evaluable participants at the RP2D as determined by the
      Dose Evaluation Committee (DEC).

      Once RP2D had been established as tolerable, 13 additional participants were enrolled in
      phase 2 to receive ASP1650 for up to a maximum of 12 cycles or until a study discontinuation
      criteria had been met, whichever occurred earlier.
allocation: Non-Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Recommended Phase 2 Dose (RP2D) of ASP1650
time frame: Up to 28 days
description: The RP2D was determined via dose limiting toxicity (DLT) assessment by dose evaluation committee (DEC). DLT was evaluated according to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTCAE) version 5.0.
measure: Percentage of Participants With Confirmed Objective Response by Modified RECIST v1.1
time frame: From randomization until confirmed CR or confirmed PR, whichever occurred first (up to 26.57 weeks)
description: Confirmed objective response was defined as the confirmed completed response (CR) or confirmed partial response (PR), as confirmed by investigator based on modified Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Per modified RECIST v1.1, CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Both Alpha-Fetoprotein (AFP) and Beta Human Chorionic Gonadotropin (beta-HCG) values were below the ULN. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. No increase ≥ 50% in 2 samples at least 1 week apart compared to nadir values for both AFP and beta-HCG.
measure: Percentage of Participants With Confirmed Objective Response by RECIST v1.1
time frame: From randomization until confirmed CR or confirmed PR, whichever occurred first (up to 26.57 weeks)
description: Confirmed objective response was defined as the confirmed CR or PR, as confirmed by investigator based on RECIST v1.1. Per RECIST v1.1, CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
measure: Percentage of Participants With Clinical Benefit by Modified RECIST v1.1 and RECIST v1.1
time frame: From randomization until confirmed CR, confirmed PR, or durable SD whichever occurred first (up to 26.57 weeks)
description: Clinical benefit: defined as best overall response of confirmed CR, confirmed PR, or durable stable disease (SD) as confirmed by investigator based on modified RECIST v1.1 and RECIST v1.1. Per RECIST v1.1 and modified RECIST V1.1, CR: disappearance of all target lesions. Any pathological lymph nodes(whether target or non-target) must have reduction in short axis to <10 mm. PR:at least a 30% decrease in sum of diameters of target lesions, taking as reference baseline sum diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference smallest sum diameters while on study. Durable SD: SD maintained for at least 12 weeks. Additionally, per modified RECIST v1.1, CR also included AFP and beta-HCG values below ULN. PR also included no increase ≥ 50% in 2 samples at least 1 week apart compared to nadir values both for AFP and beta-HCG.
measure: Duration of Response (DOR) by Modified RECIST v1.1 and RECIST v1.1 for Dose Level 2
time frame: From randomization until confirmed CR or confirmed PR whichever occurred first (up to 26.57 weeks)
description: DOR was defined as the time from the date of the first confirmed response CR or confirmed PR (whichever was first recorded) as confirmed by investigator based on modified RECIST 1.1 and RECIST v1.1 to the date of disease progression or date of censoring, whichever was earlier. If a participant had not progressed, participant was censored at the date of last disease assessment or at the date of first confirmed CR/PR if no post-baseline disease assessment was available. DOR (in days) was calculated as: (Date of documented progressive disease [PD], death, or censoring) minus (Date of the first CR/PR which was subsequently confirmed) +1. Duration of response was planned to summarized only for participants receiving dose level 2 in phase 2.
measure: Progression-Free Survival (PFS) by Modified RECIST v1.1 and RECIST v1.1 for Dose Level 2
time frame: From the date of first dose until the date of disease progression, or until death due to any cause (up to 26.57 weeks)
description: PFS was defined as the time from the date of first dose until the date of disease progression, or until death due to any cause. If a participant had neither progressed nor died, the participant was censored at the date of last disease as confirmed by investigator based on modified RECIST v1.1 and RECIST v1.1. The distribution of PFS was planned to be summarized only for participants receiving dose level 2 using Kaplan-Meier methodology. Per modified RECIST v1.1 and RECIST v1.1, Progressive disease (PD): appearance of one or more new lesions or at least a 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study (this includes the baseline sum if that is the smallest on study). Also, the sum must be an absolute increase of at least 5 mm. Additionally per modified RECIST v1.1, PD was increase ≥ 50% in serum tumor markers AFP or beta-hCG in 2 samples at least 1 week apart compared to nadir values.
measure: Number of Participants With Adverse Events (AEs)
time frame: From first dose of study drug up to 30 days after the last dose of study drug (up to 41.14 weeks)
description: An AE was defined as any untoward medical occurrence in a participant administered with an Investigational Product (IP) which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign including abnormal laboratory finding/test result or other safety assessment, symptom, or disease temporally associated with use of IP whether or not considered related to IP. A treatment-emergent adverse event (TEAE) was defined as an AE with onset at any time from first dosing until last scheduled procedure. AEs were considered serious (SAEs) if AE resulted in death, was life-threatening, resulted in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, resulted in congenital anomaly, birth defect, or required inpatient hospitalization or led to prolongation of hospitalization.
measure: Number of Participants With Shifts From Baseline to Post Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG PS)
time frame: Baseline, C2D1, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1, C9D1, C10D1, C11D1, C12D1 (Duration of each treatment cycle was 14 days)
description: Number of participants with shifts from baseline to post baseline in ECOG PS levels were reported. ECOG has 6 levels (0-5). Level 0 is fully active, able to carry on all pre-disease performance without restriction; Level 1 is restricted in physically strenuous activity but ambulatory ad able to carry out work of a light or sedentary nature, e.g. light house work, office work; Level 2 is ambulatory and capable of all self care but unable to carry out any work activities; up and about more than 50% of waking hours; Level 3 is capable of only limited self care; confined to bed or chair more than 50% of waking hours; Level 4 is completely disabled; cannot carry on any self care; totally confined to bed or chair); and Level 5 is dead.
measure: Change From Baseline in Serum Beta Human Chorionic Gonadotropin (βhCG)
time frame: Baseline, Cycle 2 Day 1 (C2D1), C3D1, C4D1, C5D1, C6D1, C7D1, C8D1, C9D1, C10D1, C11D1, C12D1 (duration of each cycle was 14 days)
description: Blood was drawn for the measurement of serum βhCG at day 1 of every cycle (14 day cycle) to align with imaging assessment until the participant develops radiological disease progression per RECIST v1.1 evaluation or starts other systemic anticancer treatment. To evaluate the effect of ASP1650 on changes in serum βhCG, disease response was derived for participants with elevated serum tumor markers at baseline using CR, PR and SD.
measure: Change From Baseline in Serum Alpha-Fetoprotein (AFP)
time frame: Baseline, C2D1, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1, C9D1, C10D1, C11D1, C12D1 (duration of each cycle was 14 days)
description: Blood was drawn for the measurement of serum AFP at day 1 of every cycle (14 day cycle) to align with imaging assessment until the participant develops radiological disease progression per RECIST v1.1 evaluation or starts other systemic anticancer treatment. To evaluate the effect of ASP1650 on changes in serum AFP, disease response was derived for participants with elevated serum tumor markers at baseline using CR, PR and SD.
measure: Pharmacokinetics (PK) of ASP1650 in Plasma: Area Under the Concentration-Time Curve Over 336 Hours (AUC336)
time frame: Dose Level 1 - CID1, C3D1: predose, 1.5 h after start of infusion, immediately after end of infusion, 0.5, 1.5, 3, 6, 24, 48, 72 h after end of infusion; Dose Level 2 - C1D1, C3D1: predose, immediately after end of infusion
description: AUC336 was derived from the Pharmacokinetic (PK) plasma samples collected. Duration of each cycle was 14 days.
measure: Pharmacokinetics (PK) of ASP1650 in Plasma: Maximum Concentration (Cmax)
time frame: Dose Level 1-CID1, C3D1: predose, 1.5 h after start of infusion, immediately after end of infusion, 0.5, 1.5, 3, 6, 24, 48, 72 h after end of infusion; Dose Level 2-C1D1, C3D1: predose, immediately after end of infusion
description: Cmax was derived from the PK plasma samples collected. Duration of each cycle was 14 days.
measure: Pharmacokinetics (PK) of ASP1650 in Plasma: Time to Maximum Concentration (Tmax)
time frame: Dose Level 1- CID1, C3D1: predose, 1.5 h after start of infusion, immediately after end of infusion, 0.5, 1.5, 3, 6, 24, 48, 72 h after end of infusion; Dose Level 2- C1D1, C3D1: predose, immediately after end of infusion
description: Tmax was derived from the PK plasma samples collected. Duration of each cycle was 14 days.
measure: Pharmacokinetics (PK) of ASP1650 in Plasma: Concentration Immediately Prior to Dosing at Multiple Dosing (Ctrough)
time frame: C2D1,C3D1,C4D1,C5D1,C6D1,C7D1,C8D1,C9D1,C10D1,C11D1,C12D1:predose,1.5 h post start of infusion, immediately post end of infusion,0.5,1.5,3,6,24,48,72 h post end of infusion for Dose Level 1, and predose, immediately post end of infusion for Dose Level 2
description: Ctrough was derived from the PK plasma samples collected. Duration of each cycle was 14 days.
arm group label: ASP1650, Dose Level 1
arm group type: Experimental
description: Participants received ASP1650 dose level 1 as intravenous infusion, every two weeks (Q2W) starting on Cycle 1 Day 1(C1D1) for up to a maximum of 12 cycles, or until disease progression, toxicity requiring study treatment cessation, start of another anticancer treatment, or until study discontinuation criteria was met, whichever occurred earlier. Duration of each treatment cycle was 14 days.
arm group label: ASP1650, Dose Level 2
arm group type: Experimental
description: Participants received ASP1650 dose level 2 as intravenous infusion, Q2W starting on C1D1 for up to a maximum of 12 cycles or until study discontinuation criteria as met, whichever occurred earlier. Duration of each treatment cycle was 14 days.
intervention type: Drug
intervention name: ASP1650
description: Participants received ASP1650 dose level 1 or dose level 2 as intravenous infusion, Q2W starting on C1D1 for up to a maximum of 12 cycles or until study discontinuation criterion was met, whichever occurred earlier. Duration of each treatment cycle was 14 days.
arm group label: ASP1650, Dose Level 1
arm group label: ASP1650, Dose Level 2
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Senior Medical Director
role: Study Director
affiliation: Astellas Pharma Global Development, Inc.
facility: 
facility: 
facility: 
country: United States
url: https://www.clinicaltrials.astellas.com/study/?pid=1650-CL-0201
description: Link to results and other applicable study documents on the Astellas Clinical Trials website.
url: https://www.trialsummaries.com/Study/StudyDetails?id=14578&tenant=MT_AST_9011
description: Link to plain language summary of the study on the Trial Results Summaries website.
responsible party type: Sponsor
mesh term: Neoplasms
mesh term: Neoplasms, Germ Cell and Embryonal
sharing ipd: No
ipd description: Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 