<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/NCT04492033</url>
  </required_header>
  <id_info>
    <org_study_id>ABL001-P1bC</org_study_id>
    <secondary_id>CTX-009-001</secondary_id>
    <nct_id>NCT04492033</nct_id>
  </id_info>
  <brief_title>A Study of CTX-009 (ABL001) in Combination With Irinotecan or Paclitaxel in Advanced or Metastatic Solid Tumor Patients</brief_title>
  <official_title>A Phase 1b/2a Multi-center Study to Assess the Safety, Tolerability, Pharmacokinetics of CTX-009 (ABL001) in Combination With Irinotecan or Paclitaxel in Patients With Advanced or Metastatic Solid Tumors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Handok Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Compass Therapeutics</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>ABL Bio, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Handok Inc.</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a Phase 1b/2 multi-center study to assess the safety, tolerability,&#xD;
      pharmacokinetics of CTX-009 (ABL001) in combination with Irinotecan or Paclitaxel in patients&#xD;
      with advanced or metastatic solid tumors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Phase 1b Study:&#xD;
&#xD;
      Indication of phase 1b study is the advanced or metastatic solid tumors (including, but not&#xD;
      limited to, colorectal cancer, gastric cancer, and ovarian cancer).&#xD;
&#xD;
      Phase 2 Study:&#xD;
&#xD;
      Indication of phase 2 study is unresectable advanced, metastatic or recurrent biliary tract&#xD;
      cancer (BTC) (including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma,&#xD;
      gallbladder cancer, and ampullary carcinoma).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 22, 2020</start_date>
  <completion_date type="Anticipated">July 31, 2025</completion_date>
  <primary_completion_date type="Anticipated">August 31, 2024</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>P1b: Proportion of subjects with Dose-Limiting Toxicity (DLT)</measure>
    <time_frame>From Day 1 until disease progression or Day 28, whichever came first</time_frame>
    <description>Number of subjects who experience DLT events during 28 days after first administration of CTX-009 (ABL001) and Irinotecan/Paclitaxel, divided by the number of DLT-evaluable subjects</description>
  </primary_outcome>
  <primary_outcome>
    <measure>P2: Objective response rate (ORR) of CTX-009 (ABL001) in combination with paclitaxel in patients with BTC</measure>
    <time_frame>Up to approximately 24 months</time_frame>
    <description>The proportion of subjects whose best overall response (BOR) is assessed to be complete response (CR) or partial response (PR) as per Independent Radiology Center's review</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse Events (AEs)</measure>
    <time_frame>Up to approximately 24 months</time_frame>
    <description>Severity of AEs will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics (PK) of CTX-009 (ABL001)</measure>
    <time_frame>Up to approximately 24 months</time_frame>
    <description>Serum concentrations of CTX-009 (ABL001) will be collected and analyzed to evaluate the PK of CTX-009 (ABL001)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective response rate (ORR)</measure>
    <time_frame>Up to approximately 24 months</time_frame>
    <description>Proportion of subject with best overall response of complete response (CR) or partial response (PR) as per investigator's review</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease control rate (DCR)</measure>
    <time_frame>Up to approximately 24 months</time_frame>
    <description>Proportion of subjects with a best overall response of complete response (CR), partial response (PR) or stable disease (SD)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to treatment failure (TTF)</measure>
    <time_frame>Up to approximately 24 months</time_frame>
    <description>Time interval from 1st administration of CTX-009 (ABL001) to the time of disease progression or discontinuation of CTX-009 (ABL001) due to whatever reason, whichever comes first</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of response (DOR)</measure>
    <time_frame>Up to approximately 24 months</time_frame>
    <description>Time interval from first occurrence of a documented objective response to the time of disease progression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival (PFS)</measure>
    <time_frame>Up to approximately 24 months</time_frame>
    <description>The time from the initiation of treatment to the first radiologic assessment that confirms progression of tumor or to death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>P2: Survival rate</measure>
    <time_frame>6 months and 12 months</time_frame>
    <description>The proportion of subjects who have survived at 6 months and 12 months from the initiation of treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>P2: Overall survival (OS)</measure>
    <time_frame>Up to approximately 24 months</time_frame>
    <description>Time from the initiation of treatment to death</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">92</enrollment>
  <condition>P1b: Advanced Solid Tumors</condition>
  <condition>P2: Biliary Tract Cancer</condition>
  <arm_group>
    <arm_group_label>CTX-009 (ABL001) and Paclitaxel (P1b)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>CTX-009 (ABL001) and Irinotecan (P1b)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1 cycle = 4weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CTX-009 (ABL001) and Paclitaxel (P2)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1 cycle = 4weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CTX-009 (ABL001)</intervention_name>
    <description>CTX-009 (ABL001) will be administered biweekly.</description>
    <arm_group_label>CTX-009 (ABL001) and Irinotecan (P1b)</arm_group_label>
    <arm_group_label>CTX-009 (ABL001) and Paclitaxel (P1b)</arm_group_label>
    <arm_group_label>CTX-009 (ABL001) and Paclitaxel (P2)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Paclitaxel</intervention_name>
    <description>Paclitaxel will be administered weekly.</description>
    <arm_group_label>CTX-009 (ABL001) and Paclitaxel (P1b)</arm_group_label>
    <arm_group_label>CTX-009 (ABL001) and Paclitaxel (P2)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Irinotecan</intervention_name>
    <description>Irinotecan will be administered biweekly.</description>
    <arm_group_label>CTX-009 (ABL001) and Irinotecan (P1b)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          -  P1b only: Patients with histologically or cytologically confirmed metastatic or&#xD;
             unresectable advanced solid tumors&#xD;
&#xD;
          -  P2 only: Patients with histologically or cytologically confirmed unresectable&#xD;
             advanced, metastatic, or recurrent biliary tract cancers (including intrahepatic&#xD;
             cholangiocarcinoma, extrahepatic cholangiocarcinoma, gallbladder cancer, ampullary&#xD;
             carcinoma)&#xD;
&#xD;
          -  P2 only: Patients who have shown disease progress or recurrence of disease after&#xD;
             receiving first-line or second-line systemic chemotherapy, including treatment with&#xD;
             gemcitabine in combination with a platinum agent&#xD;
&#xD;
          -  Patients aged 19 years or older&#xD;
&#xD;
          -  At least one lesion measurable defined by response evaluation criteria in solid tumors&#xD;
             (RECIST) version 1.1.&#xD;
&#xD;
          -  Life expectancy ≥ 12 weeks&#xD;
&#xD;
          -  ECOG performance status 0 or 1&#xD;
&#xD;
          -  Women of childbearing potential must have a negative pregnancy test outcome&#xD;
&#xD;
          -  Patients must provide written informed consent to voluntary participation in this&#xD;
             study&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          -  History of hypersensitivity reactions to any of the components of the investigational&#xD;
             product or other drugs of the same class (humanized/human monoclonal antibody) and&#xD;
             irinotecan or paclitaxel&#xD;
&#xD;
          -  Less than 4 weeks have elapsed since a surgery&#xD;
&#xD;
          -  History of cardiac illness: New York Heart Association (NYHA) class ≥ II congestive&#xD;
             heart failure (CHF), uncontrolled hypertension, hypertension crisis, pulmonary&#xD;
             hypertension, myocardial infarction, uncontrolled arrhythmia, unstable angina&#xD;
&#xD;
          -  Persistent, clinically significant NCI-CTCAE v5.0 Grade ≥ 2 toxicities from the&#xD;
             previous anticancer therapy&#xD;
&#xD;
          -  Severe infections or major and unhealed injury (active ulcer, untreated fracture)&#xD;
&#xD;
          -  Symptomatic or uncontrolled central nervous system (CNS) metastasis&#xD;
&#xD;
          -  Pregnant or lactating women or patients planning to become pregnant during the study&#xD;
&#xD;
          -  Participation in another clinical trial within 30 days prior to initiation of study&#xD;
             treatment and received an investigational drug treatment&#xD;
&#xD;
          -  Administration of antiplatelets or anticoagulants within 2 weeks prior to screening&#xD;
&#xD;
          -  Requiring continuous treatment with systemic NSAIDs or systemic corticosteroids&#xD;
&#xD;
          -  HIV or other severe diseases that warrant the exclusion from this study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>SeungJi Yoo</last_name>
    <phone>+82-2-527-5413</phone>
    <email>SeungJi.Yoo@handok.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>HyunJoo Son</last_name>
    <phone>+82-2-527-5257</phone>
    <email>HyunJoo.Son@handok.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Seoul National University Bundang Hospital</name>
      <address>
        <city>Seongnam-si</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jin Won Kim</last_name>
    </contact>
    <contact_backup>
      <last_name>Keun-Wook Lee</last_name>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kyu-Pyo Kim</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Joon Oh Park</last_name>
    </contact>
    <contact_backup>
      <last_name>Jeeyun Lee</last_name>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Do-Yeon Oh (Coordinating Investigator)</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>June 15, 2020</study_first_submitted>
  <study_first_submitted_qc>July 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <last_update_submitted>June 26, 2022</last_update_submitted>
  <last_update_submitted_qc>June 26, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 30, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>VEGF</keyword>
  <keyword>DLL4</keyword>
  <keyword>Solid Tumors</keyword>
  <keyword>Bispecific antibody</keyword>
  <keyword>anti-angiogenic</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Biliary Tract Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paclitaxel</mesh_term>
    <mesh_term>Irinotecan</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT04492033
org study id: ABL001-P1bC
secondary id: CTX-009-001
nct id: NCT04492033
lead sponsor: 
collaborator: 
collaborator: 
is fda regulated drug: Yes
is fda regulated device: No
This study is a Phase 1b/2 multi-center study to assess the safety, tolerability,
      pharmacokinetics of CTX-009 (ABL001) in combination with Irinotecan or Paclitaxel in patients
      with advanced or metastatic solid tumors.
Phase 1b Study:

      Indication of phase 1b study is the advanced or metastatic solid tumors (including, but not
      limited to, colorectal cancer, gastric cancer, and ovarian cancer).

      Phase 2 Study:

      Indication of phase 2 study is unresectable advanced, metastatic or recurrent biliary tract
      cancer (BTC) (including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma,
      gallbladder cancer, and ampullary carcinoma).
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: P1b: Proportion of subjects with Dose-Limiting Toxicity (DLT)
time frame: From Day 1 until disease progression or Day 28, whichever came first
description: Number of subjects who experience DLT events during 28 days after first administration of CTX-009 (ABL001) and Irinotecan/Paclitaxel, divided by the number of DLT-evaluable subjects
measure: P2: Objective response rate (ORR) of CTX-009 (ABL001) in combination with paclitaxel in patients with BTC
time frame: Up to approximately 24 months
description: The proportion of subjects whose best overall response (BOR) is assessed to be complete response (CR) or partial response (PR) as per Independent Radiology Center's review
measure: Adverse Events (AEs)
time frame: Up to approximately 24 months
description: Severity of AEs will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
measure: Pharmacokinetics (PK) of CTX-009 (ABL001)
time frame: Up to approximately 24 months
description: Serum concentrations of CTX-009 (ABL001) will be collected and analyzed to evaluate the PK of CTX-009 (ABL001)
measure: Objective response rate (ORR)
time frame: Up to approximately 24 months
description: Proportion of subject with best overall response of complete response (CR) or partial response (PR) as per investigator's review
measure: Disease control rate (DCR)
time frame: Up to approximately 24 months
description: Proportion of subjects with a best overall response of complete response (CR), partial response (PR) or stable disease (SD)
measure: Time to treatment failure (TTF)
time frame: Up to approximately 24 months
description: Time interval from 1st administration of CTX-009 (ABL001) to the time of disease progression or discontinuation of CTX-009 (ABL001) due to whatever reason, whichever comes first
measure: Duration of response (DOR)
time frame: Up to approximately 24 months
description: Time interval from first occurrence of a documented objective response to the time of disease progression
measure: Progression-free survival (PFS)
time frame: Up to approximately 24 months
description: The time from the initiation of treatment to the first radiologic assessment that confirms progression of tumor or to death
measure: P2: Survival rate
time frame: 6 months and 12 months
description: The proportion of subjects who have survived at 6 months and 12 months from the initiation of treatment
measure: P2: Overall survival (OS)
time frame: Up to approximately 24 months
description: Time from the initiation of treatment to death
arm group label: CTX-009 (ABL001) and Paclitaxel (P1b)
arm group type: Experimental
arm group label: CTX-009 (ABL001) and Irinotecan (P1b)
arm group type: Experimental
description: 1 cycle = 4weeks
arm group label: CTX-009 (ABL001) and Paclitaxel (P2)
arm group type: Experimental
description: 1 cycle = 4weeks
intervention type: Drug
intervention name: CTX-009 (ABL001)
description: CTX-009 (ABL001) will be administered biweekly.
arm group label: CTX-009 (ABL001) and Irinotecan (P1b)
arm group label: CTX-009 (ABL001) and Paclitaxel (P1b)
arm group label: CTX-009 (ABL001) and Paclitaxel (P2)
intervention type: Drug
intervention name: Paclitaxel
description: Paclitaxel will be administered weekly.
arm group label: CTX-009 (ABL001) and Paclitaxel (P1b)
arm group label: CTX-009 (ABL001) and Paclitaxel (P2)
intervention type: Drug
intervention name: Irinotecan
description: Irinotecan will be administered biweekly.
arm group label: CTX-009 (ABL001) and Irinotecan (P1b)
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: SeungJi Yoo
phone: +82-2-527-5413
email: SeungJi.Yoo@handok.com
last name: HyunJoo Son
phone: +82-2-527-5257
email: HyunJoo.Son@handok.com
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Biliary Tract Neoplasms
mesh term: Paclitaxel
mesh term: Irinotecan
sharing ipd: Undecided