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/NCT05981703</url>
    </required_header>
    <id_info>
      <org_study_id>BGB-A317-26808-101</org_study_id>
      <nct_id>NCT05981703</nct_id>
    </id_info>
    <brief_title>A Study Investigating BGB-26808 Alone or in Combination With Tislelizumab in Participants With Advanced Solid Tumors</brief_title>
    <official_title>A Phase 1 Study Investigating the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of HPK1 Inhibitor BGB-26808 Alone or in Combination With Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients With Advanced Solid Tumors</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>BeiGene</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>BeiGene</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is an open-label, multicenter, and nonrandomized dose escalation and dose expansion&#xD;
        study to evaluate BGB-26808 as monotherapy or in combination with tislelizumab in&#xD;
        participants with advanced solid tumors. The main purpose of this study is to explore the&#xD;
        recommended dosing for BGB-26808.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 7, 2023</start_date>
    <completion_date type="Anticipated">February 2027</completion_date>
    <primary_completion_date type="Anticipated">August 2026</primary_completion_date>
    <phase>Phase 1</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Sequential Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)</measure>
      <time_frame>Approximately 3 years</time_frame>
      <description>Number of participants with AEs and SAEs, including findings from physical examinations, electrocardiograms (ECGs), laboratory assessments, and that meet protocol-defined dose-limiting toxicity criteria.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BGB-26808</measure>
      <time_frame>Approximately 1.5 years</time_frame>
      <description>MTD is defined as the highest dose evaluated for which estimated toxicity rate is the closest to the target toxicity rate of 30%. MAD is defined as the highest dose administered if MTD is not reached.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Phase 1a: Recommended Dose for Expansion (RDFE) of BGB-26808</measure>
      <time_frame>Approximately 1.5 years</time_frame>
      <description>RDFE of BGB-26808 alone or in combination with tislelizumab will be determined based upon the MTD or MAD.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Phase 1b: Overall Response Rate (ORR)</measure>
      <time_frame>Approximately 3 years</time_frame>
      <description>ORR is defined as the percentage of participants who had confirmed complete response (CR) or partial response (PR) assessed by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Phase 1a: ORR</measure>
      <time_frame>Approximately 2 years</time_frame>
      <description>ORR is defined as the percentage of participants who had confirmed complete response (CR) or partial response (PR) assessed by the investigator using RECIST v1.1.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Phase 1a and 1b: Duration of Response (DOR)</measure>
      <time_frame>Approximately 3 years</time_frame>
      <description>DOR is defined as the time from the first determination of an objective response per RECIST v1.1 until the first documentation of disease progression or death, whichever occurs first as assessed by the investigator.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Phase 1a and 1b: Disease Control Rate (DCR)</measure>
      <time_frame>Approximately 3 years</time_frame>
      <description>DCR is defined as the percentage of participants with best overall response of CR, PR, or stable disease. It will be summarized similarly as ORR as assessed by the investigator.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Phase 1a and 1b: Clinical Benefit Rate (CBR)</measure>
      <time_frame>Approximately 3 years</time_frame>
      <description>CBR is defined as the percentage of participants with best overall response of confirmed CR, PR, or stable disease lasting ≥ 24 weeks as assessed by investigator.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Phase 1b: Progression Free Survival (PFS)</measure>
      <time_frame>Approximately 3 years</time_frame>
      <description>PFS is defined as the time from the date of the first dose of study drug(s) to the date of the first documentation of progressive disease assessed by the investigator using RECIST v1.1 or death, whichever occurs first.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Phase 1a: Maximum observed plasma concentration (Cmax) for BGB-26808</measure>
      <time_frame>Approximately 4 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Phase 1a: Minimum observed plasma concentration (Cmin) for BGB-26808</measure>
      <time_frame>Approximately 4 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Phase 1a: Time to maximum plasma concentration (Tmax) for BGB-26808</measure>
      <time_frame>Approximately 4 years</time_frame>
      <description>Pharmacokinetic analysis for BGB-26808 concentrations, alone or in combination with tislelizumab. Single-dose and steady-state PK parameters.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Phase 1a: Half-life (t1/2) for BGB-26808</measure>
      <time_frame>Approximately 4 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Phase 1a: Area under the concentration-time curve (AUC) for BGB-26808</measure>
      <time_frame>Approximately 4 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Phase 1a: Apparent clearance (CL/F) for BGB-26808</measure>
      <time_frame>Approximately 4 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Phase 1a: Apparent volume of distribution (Vz/F) for BGB-26808</measure>
      <time_frame>Approximately 4 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Phase 1a: Accumulation ratio for BGB-26808</measure>
      <time_frame>Approximately 4 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Phase 1b: Plasma concentrations of BGB-26808</measure>
      <time_frame>Approximately 4 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Phase 1b: Number of Participants with AEs and SAEs</measure>
      <time_frame>Approximately 3 years</time_frame>
      <description>Number of participants with AEs and SAEs, including findings from physical examinations, ECGs, laboratory assessments, and that meet protocol-defined dose-limiting toxicity criteria.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">90</enrollment>
    <condition>Advanced Solid Tumor</condition>
    <condition>Solid Tumor</condition>
    <arm_group>
      <arm_group_label>Dose Escalation</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Phase 1a: Sequential cohorts of increasing dose levels of BGB-26808 will be evaluated as monotherapy and in combination with tislelizumab.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Dose Expansion</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Phase 1b: The recommended dose for expansion (RDFE) for BGB-26808 (alone or in combination with tislelizumab) from Phase 1a will be evaluated.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>BGB-26808</intervention_name>
      <description>Planned doses administered orally as a tablet daily.</description>
      <arm_group_label>Dose Escalation</arm_group_label>
      <arm_group_label>Dose Expansion</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Tislelizumab</intervention_name>
      <description>Planned doses administered by intravenous infusion.</description>
      <arm_group_label>Dose Escalation</arm_group_label>
      <arm_group_label>Dose Expansion</arm_group_label>
      <other_name>BGB-A317</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Able to provide a signed and dated written informed consent prior to any&#xD;
               study-specific procedures, sampling, or data collection.&#xD;
  &#xD;
            2. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.&#xD;
  &#xD;
            3. Participants with histologically or cytologically confirmed advanced, metastatic, and&#xD;
               unresectable solid tumors that are immune-sensitive who have been previously treated.&#xD;
  &#xD;
            4. ≥ 1 measurable lesion per RECIST v1.1.&#xD;
  &#xD;
            5. Able to provide an archived tumor tissue sample.&#xD;
  &#xD;
            6. Adequate organ function.&#xD;
  &#xD;
            7. Females of childbearing potential must be willing to use a highly effective method of&#xD;
               birth control for the duration of the study, and for ≥ 90 days after the last dose of&#xD;
               BGB-26808 or for ≥ 120 days after the last dose of tislelizumab.&#xD;
  &#xD;
            8. Nonsterile males must be willing to use a highly effective method of birth control for&#xD;
               the duration of the study treatment period and for ≥ 90 days after the last dose of&#xD;
               BGB-26808 or for ≥ 120 days after the last dose of tislelizumab.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent&#xD;
               drainage or medical intervention.&#xD;
  &#xD;
            2. Clinically significant bleeding from the gastrointestinal tract within 28 days before&#xD;
               the first dose of study treatment(s).&#xD;
  &#xD;
            3. Active leptomeningeal disease or uncontrolled, untreated brain metastasis.&#xD;
  &#xD;
            4. Active autoimmune diseases or history of autoimmune diseases that may relapse&#xD;
  &#xD;
            5. Any malignancy ≤ 3 years before the first dose of study treatment(s) except for the&#xD;
               specific cancer under investigation in this study and any locally recurring cancer&#xD;
               that has been treated with curative intent (eg, resected basal or squamous cell skin&#xD;
               cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast).&#xD;
  &#xD;
            6. Any condition that required systemic treatment with either corticosteroids (&gt; 10 mg&#xD;
               daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days&#xD;
               before the first dose of study treatment(s).&#xD;
  &#xD;
            7. History of interstitial lung disease, noninfectious pneumonitis, or uncontrolled lung&#xD;
               diseases including pulmonary fibrosis, acute lung diseases.&#xD;
  &#xD;
            8. Uncontrolled diabetes.&#xD;
  &#xD;
            9. Infection (including tuberculosis infection) requiring systemic (oral or intravenous)&#xD;
               antibacterial, antifungal, or antiviral therapy ≤ 14 days before the first dose of&#xD;
               study treatment(s).&#xD;
  &#xD;
          Note: Other protocol defined Inclusion/Exclusion criteria may apply.&#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>Study Director</last_name>
      <role>Study Director</role>
      <affiliation>BeiGene</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Study Director</last_name>
      <phone>1.877.828.5568</phone>
      <email>clinicaltrials@beigene.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Linear Clinical Research</name>
        <address>
          <city>Nedlands</city>
          <state>Western Australia</state>
          <zip>6009</zip>
          <country>Australia</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location_countries>
      <country>Australia</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>September 15, 2023</last_update_submitted>
    <last_update_submitted_qc>September 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>advanced solid tumor</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Neoplasms</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Tislelizumab</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Yes</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/NCT05981703
  org study id: BGB-A317-26808-101
  nct id: NCT05981703
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  This is an open-label, multicenter, and nonrandomized dose escalation and dose expansion
        study to evaluate BGB-26808 as monotherapy or in combination with tislelizumab in
        participants with advanced solid tumors. The main purpose of this study is to explore the
        recommended dosing for BGB-26808.
  allocation: Non-Randomized
  intervention model: Sequential Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
  time frame: Approximately 3 years
  description: Number of participants with AEs and SAEs, including findings from physical examinations, electrocardiograms (ECGs), laboratory assessments, and that meet protocol-defined dose-limiting toxicity criteria.
  measure: Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BGB-26808
  time frame: Approximately 1.5 years
  description: MTD is defined as the highest dose evaluated for which estimated toxicity rate is the closest to the target toxicity rate of 30%. MAD is defined as the highest dose administered if MTD is not reached.
  measure: Phase 1a: Recommended Dose for Expansion (RDFE) of BGB-26808
  time frame: Approximately 1.5 years
  description: RDFE of BGB-26808 alone or in combination with tislelizumab will be determined based upon the MTD or MAD.
  measure: Phase 1b: Overall Response Rate (ORR)
  time frame: Approximately 3 years
  description: ORR is defined as the percentage of participants who had confirmed complete response (CR) or partial response (PR) assessed by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
  measure: Phase 1a: ORR
  time frame: Approximately 2 years
  description: ORR is defined as the percentage of participants who had confirmed complete response (CR) or partial response (PR) assessed by the investigator using RECIST v1.1.
  measure: Phase 1a and 1b: Duration of Response (DOR)
  time frame: Approximately 3 years
  description: DOR is defined as the time from the first determination of an objective response per RECIST v1.1 until the first documentation of disease progression or death, whichever occurs first as assessed by the investigator.
  measure: Phase 1a and 1b: Disease Control Rate (DCR)
  time frame: Approximately 3 years
  description: DCR is defined as the percentage of participants with best overall response of CR, PR, or stable disease. It will be summarized similarly as ORR as assessed by the investigator.
  measure: Phase 1a and 1b: Clinical Benefit Rate (CBR)
  time frame: Approximately 3 years
  description: CBR is defined as the percentage of participants with best overall response of confirmed CR, PR, or stable disease lasting ≥ 24 weeks as assessed by investigator.
  measure: Phase 1b: Progression Free Survival (PFS)
  time frame: Approximately 3 years
  description: PFS is defined as the time from the date of the first dose of study drug(s) to the date of the first documentation of progressive disease assessed by the investigator using RECIST v1.1 or death, whichever occurs first.
  measure: Phase 1a: Maximum observed plasma concentration (Cmax) for BGB-26808
  time frame: Approximately 4 years
  measure: Phase 1a: Minimum observed plasma concentration (Cmin) for BGB-26808
  time frame: Approximately 4 years
  measure: Phase 1a: Time to maximum plasma concentration (Tmax) for BGB-26808
  time frame: Approximately 4 years
  description: Pharmacokinetic analysis for BGB-26808 concentrations, alone or in combination with tislelizumab. Single-dose and steady-state PK parameters.
  measure: Phase 1a: Half-life (t1/2) for BGB-26808
  time frame: Approximately 4 years
  measure: Phase 1a: Area under the concentration-time curve (AUC) for BGB-26808
  time frame: Approximately 4 years
  measure: Phase 1a: Apparent clearance (CL/F) for BGB-26808
  time frame: Approximately 4 years
  measure: Phase 1a: Apparent volume of distribution (Vz/F) for BGB-26808
  time frame: Approximately 4 years
  measure: Phase 1a: Accumulation ratio for BGB-26808
  time frame: Approximately 4 years
  measure: Phase 1b: Plasma concentrations of BGB-26808
  time frame: Approximately 4 years
  measure: Phase 1b: Number of Participants with AEs and SAEs
  time frame: Approximately 3 years
  description: Number of participants with AEs and SAEs, including findings from physical examinations, ECGs, laboratory assessments, and that meet protocol-defined dose-limiting toxicity criteria.
  arm group label: Dose Escalation
  arm group type: Experimental
  description: Phase 1a: Sequential cohorts of increasing dose levels of BGB-26808 will be evaluated as monotherapy and in combination with tislelizumab.
  arm group label: Dose Expansion
  arm group type: Experimental
  description: Phase 1b: The recommended dose for expansion (RDFE) for BGB-26808 (alone or in combination with tislelizumab) from Phase 1a will be evaluated.
  intervention type: Drug
  intervention name: BGB-26808
  description: Planned doses administered orally as a tablet daily.
  arm group label: Dose Escalation
  arm group label: Dose Expansion
  intervention type: Drug
  intervention name: Tislelizumab
  description: Planned doses administered by intravenous infusion.
  arm group label: Dose Escalation
  arm group label: Dose Expansion
  other name: BGB-A317
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Study Director
  role: Study Director
  affiliation: BeiGene
  last name: Study Director
  phone: 1.877.828.5568
  email: clinicaltrials@beigene.com
  facility: 
  status: Recruiting
  country: Australia
  responsible party type: Sponsor
  mesh term: Neoplasms
  mesh term: Tislelizumab
  sharing ipd: Yes