Study of BGB-A333 Alone and in Combination With Tislelizumab in Advanced Solid Tumors

• Status: Terminated
• Trial end date: 2020-09-08
• Target enrollment: 0
• Participant gender: All

Summary

BGB-A333 is a humanized IgG1-variant monoclonal antibody against programmed cell death 1-ligand 1 (PD-L1), the ligand of an immune check point- receptor, programmed cell death-1 (PD-1). BGB-A317 is a humanized, IgG4-variant monoclonal antibody against PD-1. This study tested the safety and anti-tumor effect of BGB-A333 alone and in combination with BGB-A317 in participants with advanced solid tumors.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: BeiGene

Criteria

Key Inclusion Criteria:

1. Histologically or cytologically confirmed advanced or metastatic disease (unresectable) that is resistant to standard 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

Key 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 participants with hepatocellular carcinoma)

4. Concurrent participation in another therapeutic clinical trial.

5. Received prior therapies targeting PD-1 or PD-L1.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.