Phase I/II Study Investigating Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of Anti-TIM-3 Monoclonal Antibody BGB-A425 in Combination with Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients with Advanced Solid Tumors
Details
BGB-A425 is a humanized, immunoglobulin gamma-1 (IgG1)-variant monoclonal antibody against TIM-3. Tislelizumab is a humanized, immunoglobulin G4 (IgG4)-variant monoclonal antibody against PD-1. This study tests the safety and anti-tumor effect of BGB-A425 in combination with tislelizumab in participants with advanced solid tumors.
Eligibility
You can join if...
Criteria
Key Inclusion Criteria:
Phase 1: Patients with histologically or cytologically confirmed advanced, metastatic, unresectable solid tumors who have previously received standard systemic therapy or for which treatment is not available, not tolerated or refused.
Has Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1.
Phase 2: Patients with one of the following histologically or cytologically confirmed solid tumors:
Cohort 1 (HNSCC, PD-L1 positive):
Recurrent/metastatic head and neck squamous cell cancer of the oral cavity, oropharynx, hypopharynx, and/or larynx whose tumor is not amenable to local therapy with curative intent (ie, surgery or radiation therapy with or without chemotherapy
Cohort 2 (NSCLC, PD-L1 positive):
Locally recurrent Stage IIIB, stage IIIC or Stage IV squamous or non-squamous non-small cell lung cancer
Cohort 3 (RCC):
Locally advanced unresectable or metastatic and histologically confirmed renal cell carcinoma with a clear cell histology
Key Exclusion Criteria:
Active leptomeningeal disease or uncontrolled, untreated brain metastasis.
Active autoimmune diseases or history of autoimmune diseases that may relapse.
With infections (including tuberculosis infection, etc) requiring systemic antibacterial, antifungal, or antiviral therapy ≤ 14 days prior to the first dose of study drug(s), or a requirement for chronic prophylactic treatment with antibiotics.
Concurrent participation in another therapeutic clinical trial. 6. Received prior therapies targeting TIM-3.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.