Clinical Trials /

Study of BGB-A1217 in Combination With Tislelizumab in Advanced Solid Tumors

NCT04047862

Description:

The primary objectives of this study are: to assess the safety and tolerability, to determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) and to determine the recommended Phase 2 dose (RP2D) of BGB-A1217 in combination with tislelizumab in participants with advanced solid tumors.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Study of BGB-A1217 in Combination With Tislelizumab in Advanced Solid Tumors
  • Official Title: Phase 1/1b Study Investigating Safety, Tolerability, PK and Antitumor Activity of Anti-TIGIT Monoclonal Antibody BGB-A1217 in Combination With Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients With Advanced Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: BGB-900-105
  • NCT ID: NCT04047862

Conditions

  • Metastatic Solid Tumors

Interventions

DrugSynonymsArms
BGB-A1217Phase 1
TislelizumabPhase 1

Purpose

BGB-A1217 is a humanized, IgG1 monoclonal antibody against TIGIT. Tislelizumab is a humanized, IgG4-variant monoclonal antibody against PD-1. This study tests the safety and anti-tumor effect of BGB-A1217 in combination with tislelizumab in patients with advanced solid tumors.

Trial Arms

NameTypeDescriptionInterventions
Phase 1ExperimentalA modified 3+3 scheme will be used for sequential cohorts of approximately 5 increasing dose levels of BGB-A1217, evaluated in combination with 200 mg of tislelizumab, to determine the MTD or MAD, RP2D, safety, PK, and other key endpoints.
  • BGB-A1217
  • Tislelizumab

Eligibility Criteria

        Inclusion Criteria:

          1. Patients with histologically or cytologically confirmed advanced, metastatic,
             unresectable solid tumors who have previously received standard systemic therapy or
             for which treatment is not available, not tolerated or refused.

          2. Has Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1.

          3. Has adequate organ function.

        Exclusion Criteria:

          1. Active brain or leptomeningeal metastasis.

          2. Active autoimmune diseases or history of autoimmune diseases that may relapse.

          3. With severe chronic or active infections requiring systemic antibacterial, antifungal
             or antiviral therapy, including tuberculosis infection, etc. (antiviral therapy is
             permitted for patients with hepatocellular carcinoma).

          4. Concurrent participation in another therapeutic clinical trial.

          5. Received prior therapies targeting TIGIT.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Phase 1 Dose Escalation - Safety and tolerability of BGB-A1217 in combination with tislelizumab using Common Terminology Criteria for Adverse Events (CTCAE v.5.0) in patients with advanced solid tumors.
Time Frame:Up to 1.5 years
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Duration of response (DOR)
Time Frame:Up to 3 years
Safety Issue:
Description:Duration of response (DOR) will be determined from investigator derived tumor assessments per RECIST v. 1.1.
Measure:Disease control rate (DCR)
Time Frame:Up to 3 years
Safety Issue:
Description:Disease control rate (DCR) will be determined from investigator derived tumor assessments per RECIST v. 1.1.
Measure:Progression free survival
Time Frame:Up to 3 years
Safety Issue:
Description:Progression free survival will be determined from investigator derived tumor assessments per RECIST 1.1.
Measure:Immunogenicity
Time Frame:Up to 3 years
Safety Issue:
Description:Immunogenicity as assessed by the presence of anti-drug antibodies

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:BeiGene

Trial Keywords

  • BGB-A1217
  • Anti-TIGIT antibody
  • Tislelizumab
  • anti-PD-1

Last Updated

November 1, 2019