Study of BGB-A425 and LBL-007 in Combination With Tislelizumab in Advanced Solid Tumors

Prior treatment

• Chemotherapy, radiotherapy, immunotherapy or any investigational therapies within 28 days (PH 2 Safety Lead-In) or 14 days (PH 2 Dose Expansion) or 5 half-lives of (whichever is shorter) of first administration of study drug(s)
• 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
• Received prior therapies targeting TIM-3and/or LAG3
• Major surgical procedure within 28 days before study drug administration

Other illness

• Active leptomeningeal disease or uncontrolled, untreated brain metastasis.
• Active autoimmune diseases or history of autoimmune diseases that may relapse.
• Interstitial lung disease, noninfectious pneumonitis or uncontrolled lung diseases
• Uncontrolled diabetes or significant cardiac issues
• Infections requiring systemic antibacterial, antifungal, or antiviral therapy
• History of severe hypersensitivity reactions to other monoclonal antibodies
• History of HIV infection or untreated chronic hepatitis B or chronic hepatitis B virus carriers

Lab values

• NSCLC patients with known EGFR mutation, BRAF mutation, ALK fusion, or ROS1 fusion

• Has Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1.
• Adequate organ function
• Phase 1 Dose Escalation + Phase 2 Safety Lead-In: Participants with histologically or cytologically confirmed advanced, metastatic, unresectable solid tumors who have previously received standard systemic therapy or for which treatment is not available or not tolerated
• Phase 2 Dose-Expansion: Participants with one of the following histologically or cytologically confirmed solid tumors: For HNSCC participants in cohort 1,4 and 6 (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; For NSCLC participants in Cohort 2, 5 and 7 (PD-L1 positive): Locally recurrent Stage IIIB, stage IIIC or Stage IV squamous or non-squamous non-small cell lung cancer; For RCC participants in Cohort 3: Locally advanced unresectable or metastatic and histologically confirmed renal cell carcinoma with a clear cell histology.