Clinical trial · Interventional
Tislelizumab (Anti-Programmed Cell Death Protein-1 (PD-1) Antibody) in MSI-H or dMMR Solid Tumors
A Single-Arm, Multi-Center, Open-Label, Phase 2 Study to Evaluate Efficacy and Safety of Tislelizumab (BGB-A317), an Anti-PD-1 Monoclonal Antibody, as Monotherapy in Patients With Previously-Treated Locally Advanced Unresectable or Metastatic Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Solid Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
In this Phase 2, Single-Arm, Multi-Center, Open-Label Study, participants with previously treated locally advanced unresectable or metastatic solid tumors with mismatched repair deficient (dMMR) or microsatellite instability-high (MSI-H) will be treated with anti-PD-1 Monoclonal Antibody Tislelizumab (BGB-A317).
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 |
|---|---|---|---|
| MSI-H/dMMR Solid Tumors | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tislelizumab (BGB-A317) | Drug | Tislelizumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Tislelizumab (BGB-A317) Injection
- interventionNames
- Drug: Tislelizumab (BGB-A317)
Primary outcomes (1)
- measure
- Objective response rate assessed by Independent Review Committee per Response Evaluation Criteria in Solid Tumors Version 1.1
- timeFrame
- Up to 2 years
Secondary outcomes (7)
- measure
- Duration of response assessed by Independent Review Committee and by investigator per Response Evaluation Criteria in Solid Tumors Version 1.1
- timeFrame
- Up to 2 years
- measure
- Time to response assessed by Independent Review Committee and by investigator per Response Evaluation Criteria in Solid Tumors Version 1.1
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Key Inclusion Criteria: 1. Having histological confirmed diagnosis of malignancy 2. Having locally advanced unresectable or metastatic solid tumors with MSI-H or dMMR 3. Having received prior cancer therapy regimen(s) for advanced disease. 4. At least 1 measurable lesion as defined per RECIST Version (v) 1.1 5. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1 6. Adequate organ function Key Exclusion Criteria: 1. Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2 or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways 2. Active leptomeningeal disease or uncontrolled brain metastasis. 3. Clinically significant pleural effusion, pericardial effusion or ascites 4. Active autoimmune diseases or history of autoimmune diseases that may relapse 5. Any active malignancy 6. Any condition that required systemic treatment with either corticosteroids (\> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before the first dose of study drug 7. Having a history of interstitial lung disease, non-infectious pneumonitis, pulmonary fibrosis, acute lung diseases, or uncontrolled systemic diseases (including but not limited to diabetes, hypertension, etc.) 8. Participants with uncontrolled diabetes or uncontrolled electrolyte disorders despite standard medical management 9. Having severe chronic or active infections 10. A known history of human immunodeficiency virus infection 11. Child - Pugh B or greater cirrhosis 12. Any major surgical procedure ≤ 28 days before the first dose of study drug 13. Prior allogeneic stem cell transplantation or organ transplantation NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
References
Publications (0)
Data not yet available