<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/NCT04435652</url>
  </required_header>
  <id_info>
    <org_study_id>QL1604-302</org_study_id>
    <nct_id>NCT04435652</nct_id>
  </id_info>
  <brief_title>A Study of QL1604 Plus Nab-paclitaxel Versus Paclitaxel in Subjects With Advanced Gastric Cancer.</brief_title>
  <official_title>A Study of QL1604 Plus Nab-paclitaxel Versus Paclitaxel for Participants With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma That Progressed After Therapy With Platinum and Fluoropyrimidine</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Qilu Pharmaceutical Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Qilu Pharmaceutical Co., Ltd.</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a study for participants with advanced gastric or gastroesophageal junction&#xD;
      adenocarcinoma who had tumor progression after first-line treatment with platinum and&#xD;
      fluoropyrimidine doublet therapy. The study will be conducted in 2 parts.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">July 1, 2020</start_date>
  <completion_date type="Anticipated">November 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">April 30, 2022</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>The first stage is a single-arm clinical trial, and the second stage is a controlled clinical trial.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The incidence and severity of adverse events (AE) and serious adverse events (SAE) according to CTCAE V5.0</measure>
    <time_frame>Up to 90 days from last dose</time_frame>
    <description>Safety and tolerability (stage 1)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The percentages of participants discontinuing or suspending the study drug due to an AE.</measure>
    <time_frame>Up to 90 days from last dose</time_frame>
    <description>Safety and tolerability (stage 1)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall survival（OS）（stage 2）</measure>
    <time_frame>from the date of first dose until the date of death from any cause,assessed up to 2 years</time_frame>
    <description>Overall survival is defined as time from randomization to death due to any cause.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Objective response rate（ORR）assessed by the investigators according to RECIST 1.1（stage 1 and 2）</measure>
    <time_frame>up to 2 years</time_frame>
    <description>Objective response rate（ORR）assessed by the investigators according to RECIST 1.1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease control rate（DCR）assessed by the investigators according to RECIST 1.1（stage 1 and 2）</measure>
    <time_frame>up to 2 years</time_frame>
    <description>Disease control rate（DCR）assessed by the investigators according to RECIST 1.1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival（PFS）assessed by the investigators according to RECIST 1.1（stage 1 and 2）</measure>
    <time_frame>up to 2 years</time_frame>
    <description>Progression-free survival（PFS）assessed by the investigators according to RECIST 1.1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tumor response rate（TRR）assessed by the investigators according to RECIST 1.1（stage 1 and 2）</measure>
    <time_frame>up to 2 years</time_frame>
    <description>Tumor response rate（TRR）assessed by the investigators according to RECIST 1.1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival(stage 1)</measure>
    <time_frame>from the date of first dose until the date of death from any cause,assessed up to 2 years</time_frame>
    <description>Overall survival is defined as time from randomization to death due to any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the concentration-time curve (AUC ) following single dose administration of PD-1（stage 1 ）</measure>
    <time_frame>through study completion, an average of 2 years</time_frame>
    <description>Area under the concentration-time curve (AUC ) following single dose administration of PD-1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peak plasma concentration (Cmax) following single dose administration of PD-1（stage 1 ）</measure>
    <time_frame>through study completion, an average of 2 years</time_frame>
    <description>Peak plasma concentration (Cmax) following single dose administration of PD-1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Steady-state trough serum concentration of multiple Dose Administration of PD-1（stage 2）</measure>
    <time_frame>through study completion, an average of 2 years</time_frame>
    <description>Steady-state trough serum concentrationof multiple Dose Administration of PD-1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Steady-state peak serum concentration of multiple Dose Administration of PD-1（stage 2）</measure>
    <time_frame>through study completion, an average of 2 years</time_frame>
    <description>Steady-state peak serum concentration of multiple Dose Administration of PD-1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immunogenicity（stage 1 and 2）</measure>
    <time_frame>through study completion, an average of 2 years</time_frame>
    <description>The titer of anti-drug antibodies (ADA)and neutralizing antibodies(Nab).</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">492</enrollment>
  <condition>Advanced Gastric or Gastroesophageal Junction Adenocarcinoma</condition>
  <arm_group>
    <arm_group_label>Experimental: Cohort A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants receive QL1604 and nab-paclitaxel on Days 1, 8, and 15 of each 28-day cycle. If not disease progression after 4 cycles, participants receive QL1604 monotherapy until disease progression、unacceptable toxicity or up to 2 years.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experimental: Cohort B-arm1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants receive QL1604 and nab-paclitaxel on Days 1, 8, and 15 of each 28-day cycle. If not disease progression after 4 cycles, participants receive QL1604 monotherapy until disease progression、unacceptable toxicity or up to 2 years.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experimental: Cohort B-arm2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants receive paclitaxel on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>QL1604</intervention_name>
    <description>3mg/kg, D1,8,15,Q4w, IV infusion</description>
    <arm_group_label>Experimental: Cohort A</arm_group_label>
    <arm_group_label>Experimental: Cohort B-arm1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nab-paclitaxel</intervention_name>
    <description>100mg/m2, D1,8,15,Q4w, IV infusion</description>
    <arm_group_label>Experimental: Cohort A</arm_group_label>
    <arm_group_label>Experimental: Cohort B-arm1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Paclitaxel</intervention_name>
    <description>80mg/m2, D1,8,15,Q4w, IV infusion</description>
    <arm_group_label>Experimental: Cohort B-arm2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Volunteer to participate in this clinical study; Completely understand and know this&#xD;
             study as well as sign the informed consent form (ICF);&#xD;
&#xD;
          2. Age ≥ 18 years and ≤ 80 years when ICF is signed;&#xD;
&#xD;
          3. Have histologically or cytologically confirmed diagnosis of locally advanced,&#xD;
             unresectable or metastatic gastric or gastroesophageal junction&#xD;
             adenocarcinoma(G/GEJC).&#xD;
&#xD;
          4. Eastern Cooperative Oncology Group performance status of 0 or 1;&#xD;
&#xD;
          5. Life expectancy of at least 12 weeks;&#xD;
&#xD;
          6. Have measurable disease as defined by RECIST 1.1 as determined by the investigator;&#xD;
&#xD;
          7. Be willing to provide newly-obtained or paraffin-embedded tissue for PD-L1 and other&#xD;
             biomarker analysis;&#xD;
&#xD;
          8. HER-2/neu negative；&#xD;
&#xD;
          9. Female subjects of childbearing potential should have a negative serum human chorionic&#xD;
             gonadotropin(HCG) test within 7 days prior to receiving the first dose of study&#xD;
             medication and are not breastfeeding;&#xD;
&#xD;
         10. Male and female subjects able to have children must agree to use highly effective&#xD;
             method of contraception throughout the study and for at least 180 days after last&#xD;
             dose.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Has non-G/GEJC such as squamous cell carcinoma, adenosquamous carcinoma,&#xD;
             undifferentiated gastric cancer;&#xD;
&#xD;
          2. Known allergy or hypersensitivity to QL1604/nab-paclitaxel/paclitaxel or any&#xD;
             components used in the preparation;&#xD;
&#xD;
          3. Active autoimmune disease that has required systemic treatment in past 2 years (i.e.,&#xD;
             with use of disease disease-relieving drugs, corticosteroids or immunosuppressant）;&#xD;
&#xD;
          4. Has a diagnosis of immunodeficiency or received systemic steroid therapy （&gt;10mg daily&#xD;
             of prednisone or equivalent drug）or any other form of immunosuppressive therapy within&#xD;
             14 days prior to the planned start of study therapy；&#xD;
&#xD;
          5. Subjects who have received radiotherapy, chemotherapy, monoclonal antibodies,targeted&#xD;
             therapy, other anti-tumor treatments,or participating in other clinical studies is&#xD;
             less than 4 weeks before the first dose of trial treatment;&#xD;
&#xD;
          6. Has a known additional malignancy that is progressing or requires active treatment in&#xD;
             past 3 years;&#xD;
&#xD;
          7. Subjects with known central nervous system (CNS) metastasis;&#xD;
&#xD;
          8. Has a history of pneumonitis that required steroids in past 3 years;&#xD;
&#xD;
          9. Has an active infection requiring systemic therapy；&#xD;
&#xD;
         10. Subjects with the history of Human Immunodeficiency Virus (HIV)、acquired, congenital&#xD;
             immunodeficiency diseases、organ transplant;&#xD;
&#xD;
         11. Has hepatitis B surface antigen (HBsAg) positive and/or hepatitis B core antibody&#xD;
             (HBcAb) positive and HBV deoxyribonucleic acid (HBV DNA) &gt;1000 copies/mL, or hepatitis&#xD;
             C virus antibody positive;&#xD;
&#xD;
         12. Has received a live vaccine within 30 days of the planned start of study therapy；&#xD;
&#xD;
         13. Has received prior immune checkpoint inhibitors;&#xD;
&#xD;
         14. Known psychiatric or substance abuse disorders that would interfere with the&#xD;
             requirements of the study;&#xD;
&#xD;
         15. Subjects with uncontrollable cardiac diseases;&#xD;
&#xD;
         16. Has accompanying diseases that seriously endanger the subject's safety or affect the&#xD;
             study by the investigator;&#xD;
&#xD;
         17. Has any condition that increases the risk, interferes with the study results by the&#xD;
             investigator, or investigators/sponsor consider the subjects are not suitable for this&#xD;
             trial;&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Shunjiang Yu, CMO</last_name>
    <phone>0531-83129659</phone>
    <email>shunjiang.yu@qilu-pharma.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Weijian Guo, Professor</last_name>
    <phone>021-64175590</phone>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Fudan University Cancer Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>2000 32</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 10, 2020</study_first_submitted>
  <study_first_submitted_qc>June 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 17, 2020</study_first_posted>
  <last_update_submitted>June 15, 2020</last_update_submitted>
  <last_update_submitted_qc>June 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenocarcinoma</mesh_term>
    <mesh_term>Esophageal 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>Albumin-Bound Paclitaxel</mesh_term>
  </intervention_browse>
  <!-- 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/NCT04435652
org study id: QL1604-302
nct id: NCT04435652
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This is a study for participants with advanced gastric or gastroesophageal junction
      adenocarcinoma who had tumor progression after first-line treatment with platinum and
      fluoropyrimidine doublet therapy. The study will be conducted in 2 parts.
allocation: Randomized
intervention model: Single Group Assignment
intervention model description: The first stage is a single-arm clinical trial, and the second stage is a controlled clinical trial.
primary purpose: Treatment
masking: None (Open Label)
measure: The incidence and severity of adverse events (AE) and serious adverse events (SAE) according to CTCAE V5.0
time frame: Up to 90 days from last dose
description: Safety and tolerability (stage 1)
measure: The percentages of participants discontinuing or suspending the study drug due to an AE.
time frame: Up to 90 days from last dose
description: Safety and tolerability (stage 1)
measure: Overall survival（OS）（stage 2）
time frame: from the date of first dose until the date of death from any cause,assessed up to 2 years
description: Overall survival is defined as time from randomization to death due to any cause.
measure: Objective response rate（ORR）assessed by the investigators according to RECIST 1.1（stage 1 and 2）
time frame: up to 2 years
description: Objective response rate（ORR）assessed by the investigators according to RECIST 1.1.
measure: Disease control rate（DCR）assessed by the investigators according to RECIST 1.1（stage 1 and 2）
time frame: up to 2 years
description: Disease control rate（DCR）assessed by the investigators according to RECIST 1.1.
measure: Progression-free survival（PFS）assessed by the investigators according to RECIST 1.1（stage 1 and 2）
time frame: up to 2 years
description: Progression-free survival（PFS）assessed by the investigators according to RECIST 1.1.
measure: Tumor response rate（TRR）assessed by the investigators according to RECIST 1.1（stage 1 and 2）
time frame: up to 2 years
description: Tumor response rate（TRR）assessed by the investigators according to RECIST 1.1.
measure: Overall survival(stage 1)
time frame: from the date of first dose until the date of death from any cause,assessed up to 2 years
description: Overall survival is defined as time from randomization to death due to any cause.
measure: Area under the concentration-time curve (AUC ) following single dose administration of PD-1（stage 1 ）
time frame: through study completion, an average of 2 years
description: Area under the concentration-time curve (AUC ) following single dose administration of PD-1
measure: Peak plasma concentration (Cmax) following single dose administration of PD-1（stage 1 ）
time frame: through study completion, an average of 2 years
description: Peak plasma concentration (Cmax) following single dose administration of PD-1
measure: Steady-state trough serum concentration of multiple Dose Administration of PD-1（stage 2）
time frame: through study completion, an average of 2 years
description: Steady-state trough serum concentrationof multiple Dose Administration of PD-1
measure: Steady-state peak serum concentration of multiple Dose Administration of PD-1（stage 2）
time frame: through study completion, an average of 2 years
description: Steady-state peak serum concentration of multiple Dose Administration of PD-1
measure: Immunogenicity（stage 1 and 2）
time frame: through study completion, an average of 2 years
description: The titer of anti-drug antibodies (ADA)and neutralizing antibodies(Nab).
arm group label: Experimental: Cohort A
arm group type: Experimental
description: Participants receive QL1604 and nab-paclitaxel on Days 1, 8, and 15 of each 28-day cycle. If not disease progression after 4 cycles, participants receive QL1604 monotherapy until disease progression、unacceptable toxicity or up to 2 years.
arm group label: Experimental: Cohort B-arm1
arm group type: Experimental
description: Participants receive QL1604 and nab-paclitaxel on Days 1, 8, and 15 of each 28-day cycle. If not disease progression after 4 cycles, participants receive QL1604 monotherapy until disease progression、unacceptable toxicity or up to 2 years.
arm group label: Experimental: Cohort B-arm2
arm group type: Experimental
description: Participants receive paclitaxel on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.
intervention type: Drug
intervention name: QL1604
description: 3mg/kg, D1,8,15,Q4w, IV infusion
arm group label: Experimental: Cohort A
arm group label: Experimental: Cohort B-arm1
intervention type: Drug
intervention name: Nab-paclitaxel
description: 100mg/m2, D1,8,15,Q4w, IV infusion
arm group label: Experimental: Cohort A
arm group label: Experimental: Cohort B-arm1
intervention type: Drug
intervention name: Paclitaxel
description: 80mg/m2, D1,8,15,Q4w, IV infusion
arm group label: Experimental: Cohort B-arm2
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Shunjiang Yu, CMO
phone: 0531-83129659
email: shunjiang.yu@qilu-pharma.com
last name: Weijian Guo, Professor
phone: 021-64175590
facility: 
country: China
responsible party type: Sponsor
mesh term: Adenocarcinoma
mesh term: Esophageal Neoplasms
mesh term: Paclitaxel
mesh term: Albumin-Bound Paclitaxel