Clinical trial · Interventional
Study of BGB-A333 Alone and in Combination With Tislelizumab in Advanced Solid Tumors
Phase 1-2 Study Investigating Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of Anti-PD-L1 Monoclonal Antibody BGB-A333 Alone and in Combination With Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients With Advanced Solid Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study Was Terminated Early
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BGB-A317 | Drug | Tislelizumab | ALIAS |
| BGB-A333 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Phase 1A: BGB-A333 monotherapy dose escalation
- interventionNames
- Drug: BGB-A333
- type
- EXPERIMENTAL
- label
- Phase 2A: BGB-A333 monotherapy dose expansion
- interventionNames
- Drug: BGB-A333
- type
- EXPERIMENTAL
- label
- Phase 1B: BGB-A333 and BGB-A317 dose confirmation
- interventionNames
- Drug: BGB-A333
- Drug: BGB-A317
- type
- EXPERIMENTAL
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDDesai J, Fong P, Moreno V, Frentzas S, Meniawy T, Markman B, Voskoboynik M, Rahman T, Budha N, Wu J, Marlow J, Yang S, Calvo E, Martin-Liberal J. A Phase 1/2 study of the PD-L1 inhibitor, BGB-A333, alone and in combination with the PD-1 inhibitor, tislelizumab, in patients with advanced solid tumours. Br J Cancer. 2023 Apr;128(8):1418-1428. doi: 10.1038/s41416-022-02128-3. Epub 2023 Feb 16. PMID 36797356