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/NCT05998447</url>
    </required_header>
    <id_info>
      <org_study_id>[GNC] GEN001-202</org_study_id>
      <nct_id>NCT05998447</nct_id>
    </id_info>
    <brief_title>GEN-001 Plus Pembrolizumab for Patients With Advanced Refractory Biliary Tract Cancer</brief_title>
    <official_title>A Phase II Study to Evaluate the Safety and the Efficacy of GEN-001 in Combination With Pembrolizumab for Patients With Advanced Refractory Biliary Tract Cancer</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Genome &amp; Company</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Merck Sharp &amp; Dohme LLC</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Genome &amp; Company</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>
        This is a phase II, multicenter, open-label study with a safety run-in to evaluate the safety&#xD;
        and efficacy of GEN-001 in combination with pembrolizumab or in combination with&#xD;
        pembrolizumab and mFOLFOX for patients with advanced refractory BTC who have progressed after&#xD;
        1 or 2 prior standard therapy and are not candidates for any other standard therapy. The&#xD;
        safety run-in phase will be conducted before the main study phase&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">October 2026</completion_date>
    <primary_completion_date type="Anticipated">October 2026</primary_completion_date>
    <phase>Phase 2</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The recommended Phase 2 dose (RP2D) of GEN-001 in patients with advanced refractory biliary tract cancer (BTC), when administered as combined with pembrolizumab or as combined with pembrolizumab and mFOLFOX.</measure>
      <time_frame>1 years</time_frame>
      <description>Incidence of dose-limiting toxicity (DLT)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by the Investigator.</measure>
      <time_frame>1 years</time_frame>
      <description>The assessment of the anti-tumor activity per cohort</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Incidence of Adverse Event (AE)s and laboratory abnormalities per National Cancer Institute Common Terminology Criteria for AEs (NCI CTCAE) v.5.0. cohort.</measure>
      <time_frame>1 years</time_frame>
      <description>The assessment the overall safety and tolerability per cohort.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of Response (DoR)</measure>
      <time_frame>1 years</time_frame>
      <description>the time from the first documentation of objective tumor response to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Progression-free Survival (PFS)</measure>
      <time_frame>1 years</time_frame>
      <description>the time from the start date of treatment to the date of PD by RECIST v1.1 or death due to any cause, whichever occurs first</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall Survival (OS)</measure>
      <time_frame>1 years</time_frame>
      <description>the time from the start date of treatment to the date of death</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">148</enrollment>
    <condition>Biliary Tract Cancer</condition>
    <arm_group>
      <arm_group_label>GEN-001 with pembrolizumab or GEN-001 with pembrolizumab and mFOLFOX</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Drug: GEN-001&#xD;
  Drug: pembrolizumab&#xD;
  Drug: mFOLFOX</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>GEN-001</intervention_name>
      <description>The capsules taken by mouth. Each capsule will contain ≥ 3x10^11 colony-forming units (CFU)</description>
      <arm_group_label>GEN-001 with pembrolizumab or GEN-001 with pembrolizumab and mFOLFOX</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Pembrolizumab</intervention_name>
      <description>200 mg given by intravenous (IV) infusion once every 3 weeks</description>
      <arm_group_label>GEN-001 with pembrolizumab or GEN-001 with pembrolizumab and mFOLFOX</arm_group_label>
      <other_name>Keytruda</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>mFOLFOX</intervention_name>
      <description>mFOLFOX given by intravenous (IV) once every 2 weeks for only cohort 3</description>
      <arm_group_label>GEN-001 with pembrolizumab or GEN-001 with pembrolizumab and mFOLFOX</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  The patient (or legally acceptable representative if applicable) provides written&#xD;
               informed consent for the trial.&#xD;
  &#xD;
            -  Be ≥19 years of age on day of signing informed consent.&#xD;
  &#xD;
            -  Patient with histologically or cytologically confirmed diagnosis of unresectable,&#xD;
               recurrent, or metastatic advanced biliary tract adenocarcinoma of the gallbladder or&#xD;
               biliary tree (either intrahepatic or extrahepatic cholangiocarcinoma)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  A WOCBP who has a positive urine pregnancy test (within 72 hours) prior to treatment.&#xD;
               If the urine test is positive or cannot be confirmed as negative, a serum pregnancy&#xD;
               test will be required.&#xD;
  &#xD;
            -  Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with&#xD;
               an agent directed to another stimulatory or co-inhibitory T-cell receptor (Cohort 1&#xD;
               only), and was discontinued from the previous IO therapy due to a Grade 3 or higher&#xD;
               immune-related AE (irAE) (Cohort 2 and Cohort 3).&#xD;
  &#xD;
            -  Is currently participating and receiving study treatments or has participated in a&#xD;
               study of an investigational agent and received the study therapy or has used an&#xD;
               investigational device within 4 weeks prior to the first dose of study treatment.&#xD;
  &#xD;
            -  Has had an allogeneic tissue/solid organ transplan&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>19 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 1, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</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>Biliary Tract Neoplasms</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pembrolizumab</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/NCT05998447
  org study id: [GNC] GEN001-202
  nct id: NCT05998447
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This is a phase II, multicenter, open-label study with a safety run-in to evaluate the safety
        and efficacy of GEN-001 in combination with pembrolizumab or in combination with
        pembrolizumab and mFOLFOX for patients with advanced refractory BTC who have progressed after
        1 or 2 prior standard therapy and are not candidates for any other standard therapy. The
        safety run-in phase will be conducted before the main study phase
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: The recommended Phase 2 dose (RP2D) of GEN-001 in patients with advanced refractory biliary tract cancer (BTC), when administered as combined with pembrolizumab or as combined with pembrolizumab and mFOLFOX.
  time frame: 1 years
  description: Incidence of dose-limiting toxicity (DLT)
  measure: Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by the Investigator.
  time frame: 1 years
  description: The assessment of the anti-tumor activity per cohort
  measure: Incidence of Adverse Event (AE)s and laboratory abnormalities per National Cancer Institute Common Terminology Criteria for AEs (NCI CTCAE) v.5.0. cohort.
  time frame: 1 years
  description: The assessment the overall safety and tolerability per cohort.
  measure: Duration of Response (DoR)
  time frame: 1 years
  description: the time from the first documentation of objective tumor response to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first
  measure: Progression-free Survival (PFS)
  time frame: 1 years
  description: the time from the start date of treatment to the date of PD by RECIST v1.1 or death due to any cause, whichever occurs first
  measure: Overall Survival (OS)
  time frame: 1 years
  description: the time from the start date of treatment to the date of death
  arm group label: GEN-001 with pembrolizumab or GEN-001 with pembrolizumab and mFOLFOX
  arm group type: Experimental
  description: Drug: GEN-001
  Drug: pembrolizumab
  Drug: mFOLFOX
  intervention type: Drug
  intervention name: GEN-001
  description: The capsules taken by mouth. Each capsule will contain ≥ 3x10^11 colony-forming units (CFU)
  arm group label: GEN-001 with pembrolizumab or GEN-001 with pembrolizumab and mFOLFOX
  intervention type: Drug
  intervention name: Pembrolizumab
  description: 200 mg given by intravenous (IV) infusion once every 3 weeks
  arm group label: GEN-001 with pembrolizumab or GEN-001 with pembrolizumab and mFOLFOX
  other name: Keytruda
  intervention type: Drug
  intervention name: mFOLFOX
  description: mFOLFOX given by intravenous (IV) once every 2 weeks for only cohort 3
  arm group label: GEN-001 with pembrolizumab or GEN-001 with pembrolizumab and mFOLFOX
  criteria: 
  gender: All
  minimum age: 19 Years
  maximum age: N/A
  healthy volunteers: No
  responsible party type: Sponsor
  mesh term: Biliary Tract Neoplasms
  mesh term: Pembrolizumab
  sharing ipd: No