Tislelizumab (Anti-Programmed Cell Death Protein-1 (PD-1) Antibody) in MSI-H or dMMR Solid Tumors

• Status: Recruiting
• Trial end date: 2022-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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). Efficacy and safety will be assessed. A short description of the clinical study, including a brief statement of the clinical study's hypothesis, written in language intended for the lay public.

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

Details

• Lead Sponsor: BeiGene
• Treatments: Antibodies; Immunoglobulins

Criteria

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 or refused 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.