xml: <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/NCT05964543</url>
    </required_header>
    <id_info>
      <org_study_id>Q-1802-201</org_study_id>
      <nct_id>NCT05964543</nct_id>
    </id_info>
    <brief_title>The Safety and Efficacy of Q-1802 Combined With XELOX in Gastrointestinal Tumors</brief_title>
    <official_title>A Phase I/II Clinical Trial to Evaluate the Safety Tolerance and Initial Efficacy of Q-1802 Combined With Standard Treatment in Patients With Gastrointestinal Tumors</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>QureBio Ltd.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>QureBio Ltd.</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The main purpose of this study is to evaluate safety, tolerability and the efficacy of Q-1802&#xD;
        plus SOC compared with SOC. .Pharmacokinetics (PK) ,Pharmacodynamics (PD) of Q-1802 and the&#xD;
        immunogenicity profile of Q-1802 will be evaluated as well.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study is a multicenter, open label, phase Ⅰb/Ⅱ clinical study conducted in unresectable&#xD;
        patients with advanced or recurrent metastatic Claudin18.2 positive (medium and high&#xD;
        expression) and HER-2 negative primary gastric adenocarcinoma or gastric esophageal junction&#xD;
        adenocarcinoma. The Phase Ib dose escalation study included two dose groups each combined&#xD;
        with the XELOX standard treatment regimen. Perform dose escalation to obtain MTD and/or RP2D&#xD;
        doses for combined administration. The Phase II study adopted an open label parallel&#xD;
        randomized controlled design. Further observe the efficacy and safety of Q-1802 combined with&#xD;
        XELOX regimen in treating patients with moderate to high expression of Claudin 18.2, and&#xD;
        compare and analyze the efficacy and safety of Q-1802 combined with XELOX regimen and XELOX&#xD;
        regimen alone.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 21, 2023</start_date>
    <completion_date type="Anticipated">August 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">August 30, 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>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Phase Ib: Dose escalation;Phase II:Arm A：Combined administration group Q-1802 plus XELOX,Arm B Standard treatment group: XELOX alone</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Number of participants with treatment-related adverse events(TRAE)</measure>
      <time_frame>From the first dose of study drug administration up to 30 days after the last study medication administration, up to 12months</time_frame>
      <description>TRAE is defined as the AEs that the casual relationship of the AE is ralated to Q-1802</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Objective response rate (ORR)</measure>
      <time_frame>From the first dose of study drug administration up to 6 months after the last pts in,up to19 months</time_frame>
      <description>ORR is defined as proportion of participants with complete response, partial response (CR+PR).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Progression-free survival (PFS)</measure>
      <time_frame>From the first dose of study drug administration up to the last pts who disease progression or death which occurs first,up to 21months</time_frame>
      <description>PFS is defined as the interval of time between the date of first treatment to the earliest date of disease progression or death which occurs first.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">72</enrollment>
    <condition>Gastroesophageal Junction (GEJ) Adenocarcinoma</condition>
    <arm_group>
      <arm_group_label>Phase Ib: Dose escalation Q-1802+XELOX,</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>According to &quot;3+3&quot; design, a dose of Q-1802 with two dose groups from low to high and one cycle fixed-dose XELOX will be given in DLT observation period. After DLT observation period, Q-1802+XELOX will be given by investigator,s decision until the subject meets study treatment discontinuation criteria.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Phase II: Q-1802 + XELOX Vs XELOX ;</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Phase II:Participants will be randomized to group A and B. Group A:receive a dose of Q-1802 at Cycle 1 Day 1 followed by a same dose in subsequent cycles every 2 weeks. Additionally, participants will receive XELOX (capecitabine/oxaliplatin) treatment until investigator confirmed disease progression or a total of 8 treatments (each cycle is defined as approximately 21 days). Oxaliplatin is administered on day 1 of each cycle, whereas capecitabine is taken twice daily on days 1 through 14. After a maximum of 8 treatments of Oxaplatin, subjects may continue to receive Q-1802 a every 2 weeks each cycle and capecitabine every 3 weeks at the investigator's discretion until the subject meets study treatment discontinuation criteria. Group B:Participants will receive XELOX (capecitabine/oxaliplatin) treatment alone until a total of 8 treatments (each cycle is defined as approximately 21 days). subjects may continue to receive capecitabine every 3 weeks at the investigator's discretion.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Q-1802 Injection,Oxaliplatin Injection,Capecitabine</intervention_name>
      <description>Q-1802：A dose Q-1802 will be administered intravenously Q2W. XELOX（oxaliplatin，capecitabin）: 21 days as a cycle Oxaliplatin will be administered 130mg/m2 as a 2-hour IV infusion,administer once on the first day, with 21 days as a cycle Capecitabine will be administered 1000mg/m2 orally twice daily (D1-D14),21ds is one cycle.</description>
      <arm_group_label>Phase II: Q-1802 + XELOX Vs XELOX ;</arm_group_label>
      <arm_group_label>Phase Ib: Dose escalation Q-1802+XELOX,</arm_group_label>
      <other_name>Q-1802,Oxaliplatin Injection,Xeloda</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion criteria：&#xD;
  &#xD;
          Patients with at least one measurable lesion per RECIST (v1.1);&#xD;
  &#xD;
          Patients with medium or high expression of Claudin18.2 in tumor tissue samples tested by&#xD;
          immunohistochemistry in central laboratory were included;&#xD;
  &#xD;
          Patients with untreated, unresectable advanced or metastatic gastric adenocarcinoma or&#xD;
          gastroesophageal junction adenocarcinoma with negative HER-2 immunohistochemistry or FISH&#xD;
          test (HER-2 immunohistochemistry 0/1+ confirmed by a qualified local or central laboratory,&#xD;
          or 2+ confirmed negative by FISH test) were included;&#xD;
  &#xD;
          Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1 at screening and&#xD;
          no deterioration occurs within two weeks before enrollment;&#xD;
  &#xD;
          Life expectancy period ≥ 12 weeks;&#xD;
  &#xD;
          Patients who have sufficient baseline organ function.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Receive anti-tumor treatment within 4 weeks before the first administration or within 5&#xD;
          half-lives of the treatment drug, whichever is shorter;&#xD;
  &#xD;
          Patients who have previously used Claudin 18.2 products for treatment;&#xD;
  &#xD;
          With uncontrolled diseases;&#xD;
  &#xD;
          Who are allergic to the study drug or any of its components;&#xD;
  &#xD;
          Patients with a history of other primary malignant tumors at the time of screening, except&#xD;
          for cured skin Basal-cell carcinoma or Cutaneous squamous-cell carcinoma or cervical&#xD;
          Carcinoma in situ.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Lin Shen, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Department of Medical Oncology, Beijing</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>LI WEI, MD</last_name>
      <phone>86-021-50920280</phone>
      <email>weili@qurebio.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Beijing cancer hospical</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <zip>100142</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Lin Shen, MD</last_name>
        <phone>86-13911219511</phone>
        <email>shenlin@bjmu.edu.cn</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 19, 2023</study_first_submitted>
    <study_first_submitted_qc>July 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>July 27, 2023</last_update_submitted>
    <last_update_submitted_qc>July 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Neoplasms</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Digestive System Neoplasms</mesh_term>
      <mesh_term>Gastrointestinal Neoplasms</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Capecitabine</mesh_term>
      <mesh_term>Oxaliplatin</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05964543
  org study id: Q-1802-201
  nct id: NCT05964543
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The main purpose of this study is to evaluate safety, tolerability and the efficacy of Q-1802
        plus SOC compared with SOC. .Pharmacokinetics (PK) ,Pharmacodynamics (PD) of Q-1802 and the
        immunogenicity profile of Q-1802 will be evaluated as well.
  This study is a multicenter, open label, phase Ⅰb/Ⅱ clinical study conducted in unresectable
        patients with advanced or recurrent metastatic Claudin18.2 positive (medium and high
        expression) and HER-2 negative primary gastric adenocarcinoma or gastric esophageal junction
        adenocarcinoma. The Phase Ib dose escalation study included two dose groups each combined
        with the XELOX standard treatment regimen. Perform dose escalation to obtain MTD and/or RP2D
        doses for combined administration. The Phase II study adopted an open label parallel
        randomized controlled design. Further observe the efficacy and safety of Q-1802 combined with
        XELOX regimen in treating patients with moderate to high expression of Claudin 18.2, and
        compare and analyze the efficacy and safety of Q-1802 combined with XELOX regimen and XELOX
        regimen alone.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Phase Ib: Dose escalation;Phase II:Arm A：Combined administration group Q-1802 plus XELOX,Arm B Standard treatment group: XELOX alone
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Number of participants with treatment-related adverse events(TRAE)
  time frame: From the first dose of study drug administration up to 30 days after the last study medication administration, up to 12months
  description: TRAE is defined as the AEs that the casual relationship of the AE is ralated to Q-1802
  measure: Objective response rate (ORR)
  time frame: From the first dose of study drug administration up to 6 months after the last pts in,up to19 months
  description: ORR is defined as proportion of participants with complete response, partial response (CR+PR).
  measure: Progression-free survival (PFS)
  time frame: From the first dose of study drug administration up to the last pts who disease progression or death which occurs first,up to 21months
  description: PFS is defined as the interval of time between the date of first treatment to the earliest date of disease progression or death which occurs first.
  arm group label: Phase Ib: Dose escalation Q-1802+XELOX,
  arm group type: Experimental
  description: According to "3+3" design, a dose of Q-1802 with two dose groups from low to high and one cycle fixed-dose XELOX will be given in DLT observation period. After DLT observation period, Q-1802+XELOX will be given by investigator,s decision until the subject meets study treatment discontinuation criteria.
  arm group label: Phase II: Q-1802 + XELOX Vs XELOX ;
  arm group type: Placebo Comparator
  description: Phase II:Participants will be randomized to group A and B. Group A:receive a dose of Q-1802 at Cycle 1 Day 1 followed by a same dose in subsequent cycles every 2 weeks. Additionally, participants will receive XELOX (capecitabine/oxaliplatin) treatment until investigator confirmed disease progression or a total of 8 treatments (each cycle is defined as approximately 21 days). Oxaliplatin is administered on day 1 of each cycle, whereas capecitabine is taken twice daily on days 1 through 14. After a maximum of 8 treatments of Oxaplatin, subjects may continue to receive Q-1802 a every 2 weeks each cycle and capecitabine every 3 weeks at the investigator's discretion until the subject meets study treatment discontinuation criteria. Group B:Participants will receive XELOX (capecitabine/oxaliplatin) treatment alone until a total of 8 treatments (each cycle is defined as approximately 21 days). subjects may continue to receive capecitabine every 3 weeks at the investigator's discretion.
  intervention type: Drug
  intervention name: Q-1802 Injection,Oxaliplatin Injection,Capecitabine
  description: Q-1802：A dose Q-1802 will be administered intravenously Q2W. XELOX（oxaliplatin，capecitabin）: 21 days as a cycle Oxaliplatin will be administered 130mg/m2 as a 2-hour IV infusion,administer once on the first day, with 21 days as a cycle Capecitabine will be administered 1000mg/m2 orally twice daily (D1-D14),21ds is one cycle.
  arm group label: Phase II: Q-1802 + XELOX Vs XELOX ;
  arm group label: Phase Ib: Dose escalation Q-1802+XELOX,
  other name: Q-1802,Oxaliplatin Injection,Xeloda
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Lin Shen, MD
  role: Principal Investigator
  affiliation: Department of Medical Oncology, Beijing
  last name: LI WEI, MD
  phone: 86-021-50920280
  email: weili@qurebio.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Digestive System Neoplasms
  mesh term: Gastrointestinal Neoplasms
  mesh term: Capecitabine
  mesh term: Oxaliplatin
  sharing ipd: No