Overview
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).
Eligibility
Key Inclusion Criteria:
- Having histological confirmed diagnosis of malignancy
- Having locally advanced unresectable or metastatic solid tumors with MSI-H or dMMR
- Having received prior cancer therapy regimen(s) for advanced disease.
- At least 1 measurable lesion as defined per RECIST Version (v) 1.1
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1
- Adequate organ function
Key Exclusion Criteria:
- 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
- Active leptomeningeal disease or uncontrolled brain metastasis.
- Clinically significant pleural effusion, pericardial effusion or ascites
- Active autoimmune diseases or history of autoimmune diseases that may relapse
- Any active malignancy
- 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
- 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.)
- Participants with uncontrolled diabetes or uncontrolled electrolyte disorders despite standard medical management
- Having severe chronic or active infections
- A known history of human immunodeficiency virus infection
- Child - Pugh B or greater cirrhosis
- Any major surgical procedure ≤ 28 days before the first dose of study drug
- Prior allogeneic stem cell transplantation or organ transplantation
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.