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

BeiGene

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Advanced Solid Tumors

Treatments: Drug: BGB-A317; Drug: BGB-A333

Study type: Interventional

Funder types: Industry

Identifiers

NCT03379259

BGB-900-101

2018-000265-37 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 39 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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39 participants in 4 patient groups

Phase 1A: BGB-A333 monotherapy dose escalation

Experimental group

Treatment:

Drug: BGB-A333

Phase 2A: BGB-A333 monotherapy dose expansion

Experimental group

Treatment:

Drug: BGB-A333

Phase 1B: BGB-A333 and BGB-A317 dose confirmation

Experimental group

Treatment:

Drug: BGB-A333

Drug: BGB-A317

Phase 2B: BGB-A333 and BGB-A317 dose expansion

Experimental group

Treatment:

Drug: BGB-A333

Drug: BGB-A317