BGB-A317-30813-101: This study will test whether taking a new anti-cancer drug (called BGB-30813) alone, or in addition to targeted therapy (called tislelizumab) can help treat people with cancer that has spread throughout the body or is locally advancedA Phase 1a/1b Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of the DGKζ Inhibitor BGB-30813, Alone or in Combination With the Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients With Advanced or Metastatic Solid Tumors

Inclusion

• Phase 1a (Dose Escalation):

  • Participants with histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors who have previously received available standard systemic therapy or for whom treatment is not available or not tolerated and who have not received any prior therapy targeting diacylglycerol kinase ζ (DGK)

    • Eligible tumor types are immune sensitive solid tumors such as NSCLC, HNSCC, small cell lung cancer, hepatocellular carcinoma, esophageal cancer, gastric or gastroesophageal carcinoma, nasopharyngeal carcinoma, triple-negative breast cancer, urothelial carcinoma, renal cell carcinoma, cervical cancer, endometrial carcinoma, cutaneous squamous cell carcinoma, melanoma, Merkel cell carcinoma, mesothelioma, microsatellite instability (MSI)-high, tumor mutation burden (TMB)-high, or mismatch repair deficient solid tumors
    • Prior checkpoint inhibitor (CPI) therapy is allowed

• Phase 1b (Dose Expansion):

  • Participants with selected advanced or metastatic solid tumors including NSCLC, HNSCC, and additional potential tumor types to be defined based on emerging data
• ≥ 1 measurable lesion per RECIST v1.1
• Eastern Cooperative Group Oncology Performance (ECOG) Performance Status score ≤ 1
• Females of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study
• Adequate organ function as indicated by the following laboratory values up to first dose of study treatment: Hemoglobin≥ 90 grams per liter (g/L), Absolute neutrophil count ≥ 1.5 x 109/L , Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN) (< 3 x ULN for participants with Gilbert syndrome ), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN