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/NCT06008288</url>
    </required_header>
    <id_info>
      <org_study_id>JAB-21822-2001</org_study_id>
      <nct_id>NCT06008288</nct_id>
    </id_info>
    <brief_title>A Study of JAB-21822 in Patients With KRAS p.G12C Mutated Pancreatic Cancer</brief_title>
    <official_title>A Phase 2, Multi-Center, Open-Label, Single-arm Study to Evaluate the Efficacy and Safety of JAB-21822 Monotherapy in Patients With Locally Advanced or Metastatic KRAS p.G12C Mutated Pancreatic Cancer</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Jacobio Pharmaceuticals Co., Ltd.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Jacobio Pharmaceuticals 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 study is to evaluate the efficacy and safety of JAB-21822 monotherapy in adult&#xD;
        participants with KRAS G12C mutated pancreatic cancer&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a single-arm, open-label, multicenter phase 2 study to evaluate the efficacy and&#xD;
        safety of JAB-21822 monotherapy in adult participants with advanced KRAS p.G12C mutated&#xD;
        pancreatic cancer.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 2023</start_date>
    <completion_date type="Anticipated">November 2025</completion_date>
    <primary_completion_date type="Anticipated">May 2025</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>Objective response rate (ORR) by independent central radiological review (IRC) according to RECIST 1.1.</measure>
      <time_frame>Approximately 1.5 years</time_frame>
      <description>ORR is defined as the proportion of participants with confirmed complete response or partial response by IRC according to RECIST 1.1.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Duration of response (DOR)</measure>
      <time_frame>Approximately 1.5 years</time_frame>
      <description>DOR is defined as the time from date of the first objective tumor response (CR or PR) to the first documentation of either Progression of Disease (PD) or death due to any cause, whichever occurs first.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to response (TTR) by IRC according to RECIST 1.1</measure>
      <time_frame>Approximately 1.5 years</time_frame>
      <description>TTR is defined as the duration of time between the date of the first dose and the date of first documented response of either CR or PR.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Progression-free survival (PFS) by IRC according to RECIST 1.1</measure>
      <time_frame>Approximately 1.5 years</time_frame>
      <description>PFS is defined as time from the first dose until disease progression or death from any cause, whichever occurs first.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Disease control rate (DCR) by IRC according to RECIST 1.1</measure>
      <time_frame>Approximately 1.5 years</time_frame>
      <description>DCR is defined as the proportion of participants with BOR of CR or PR or stable disease (SD)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>CA19-9 response rate</measure>
      <time_frame>Approximately 1.5 years</time_frame>
      <description>CA19-9 response rate is defined as the proportion of participants with CA19-9 response (achieving ≥50% decrease in CA19-9 serum levels).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall survival (OS)</measure>
      <time_frame>Approximately 2.0 years</time_frame>
      <description>OS is defined as time from date of the first dose to date of death due to any cause.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants with adverse events</measure>
      <time_frame>Approximately 1.5 years</time_frame>
      <description>Participants will be assessed for incidence and severity of AEs according to NCI-CTCAE 5.0 criteria</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">69</enrollment>
    <condition>KRAS P.G12C</condition>
    <condition>Pancreatic Cancer</condition>
    <arm_group>
      <arm_group_label>JAB-21822</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Monotherapy</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>JAB-21822</intervention_name>
      <description>800mg, orally QD with 21 days each cycle, treatment till disease progression or intolerable toxicity or withdraw for other reasons</description>
      <arm_group_label>JAB-21822</arm_group_label>
      <other_name>Glecirasib</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Histopathologically or cytologically confirmed pancreatic cancer with KRAS p.G12C&#xD;
               mutation identified through molecular testing.&#xD;
  &#xD;
            -  Previously progressed on or after gemcitabine-based and/or FOFIRINOX/mFOFIRINOX&#xD;
               chemotherapy, no more than 3 lines of prior systemic therapies. Participants with&#xD;
               disease recurrence during or within 6 months after adjuvant therapy can be included.&#xD;
  &#xD;
            -  Participants with MSI-H/dMMR must experience anti-PD-1 therapy.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Previously received a KRAS G12C inhibitor.&#xD;
  &#xD;
            -  History of interstitial lung disease, non-infectious pneumonia, or uncontrolled lung&#xD;
               disease (including pulmonary fibrosis, acute lung disease, etc.).&#xD;
  &#xD;
            -  Uncontrolled pleural effusion, pericardial effusion, or ascites.&#xD;
  &#xD;
            -  Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥470 ms&#xD;
               calculated from 3 electrocardiograms.&#xD;
  &#xD;
            -  Use of a drug with known risk of torsades de points (TdP) within 14 days prior to the&#xD;
               first dose.&#xD;
  &#xD;
            -  Cannot discontinue a proton pump inhibitor (PPI) or H2 receptor blocker within 3 days&#xD;
               or 5 half-lives (whichever is longer) prior to the first dose.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Jacobio Pharmaceuticals</last_name>
      <role>Study Director</role>
      <affiliation>Jacobio Pharmaceuticals</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jacobio Pharmaceuticals</last_name>
      <phone>86-10-56315466</phone>
      <email>clinicaltrials@jacobiopharma.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Beijing Cancer Hospital</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <zip>100142</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Peking Union Medical College Hospital</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <zip>100730</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 18, 2023</study_first_submitted>
    <study_first_submitted_qc>August 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 18, 2023</last_update_submitted>
    <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 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>Pancreatic Neoplasms</mesh_term>
    </condition_browse>
    <!-- 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/NCT06008288
  org study id: JAB-21822-2001
  nct id: NCT06008288
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This study is to evaluate the efficacy and safety of JAB-21822 monotherapy in adult
        participants with KRAS G12C mutated pancreatic cancer
  This is a single-arm, open-label, multicenter phase 2 study to evaluate the efficacy and
        safety of JAB-21822 monotherapy in adult participants with advanced KRAS p.G12C mutated
        pancreatic cancer.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Objective response rate (ORR) by independent central radiological review (IRC) according to RECIST 1.1.
  time frame: Approximately 1.5 years
  description: ORR is defined as the proportion of participants with confirmed complete response or partial response by IRC according to RECIST 1.1.
  measure: Duration of response (DOR)
  time frame: Approximately 1.5 years
  description: DOR is defined as the time from date of the first objective tumor response (CR or PR) to the first documentation of either Progression of Disease (PD) or death due to any cause, whichever occurs first.
  measure: Time to response (TTR) by IRC according to RECIST 1.1
  time frame: Approximately 1.5 years
  description: TTR is defined as the duration of time between the date of the first dose and the date of first documented response of either CR or PR.
  measure: Progression-free survival (PFS) by IRC according to RECIST 1.1
  time frame: Approximately 1.5 years
  description: PFS is defined as time from the first dose until disease progression or death from any cause, whichever occurs first.
  measure: Disease control rate (DCR) by IRC according to RECIST 1.1
  time frame: Approximately 1.5 years
  description: DCR is defined as the proportion of participants with BOR of CR or PR or stable disease (SD)
  measure: CA19-9 response rate
  time frame: Approximately 1.5 years
  description: CA19-9 response rate is defined as the proportion of participants with CA19-9 response (achieving ≥50% decrease in CA19-9 serum levels).
  measure: Overall survival (OS)
  time frame: Approximately 2.0 years
  description: OS is defined as time from date of the first dose to date of death due to any cause.
  measure: Number of participants with adverse events
  time frame: Approximately 1.5 years
  description: Participants will be assessed for incidence and severity of AEs according to NCI-CTCAE 5.0 criteria
  arm group label: JAB-21822
  arm group type: Experimental
  description: Monotherapy
  intervention type: Drug
  intervention name: JAB-21822
  description: 800mg, orally QD with 21 days each cycle, treatment till disease progression or intolerable toxicity or withdraw for other reasons
  arm group label: JAB-21822
  other name: Glecirasib
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Jacobio Pharmaceuticals
  role: Study Director
  affiliation: Jacobio Pharmaceuticals
  last name: Jacobio Pharmaceuticals
  phone: 86-10-56315466
  email: clinicaltrials@jacobiopharma.com
  facility: 
  facility: 
  country: China
  responsible party type: Sponsor
  mesh term: Pancreatic Neoplasms