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A Phase 1 Study Investigating the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of HPK1 Inhibitor BGB-15025 Alone and in Combination With Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients With Advanced Solid Tumors
BeiGene Australia Pty Ltd
This is a non-randomised trial with one experimental arm, that has two phases. Phase 1a (dose escalation) has two parts. In Phase 1a, Part A, participants will receive BGB-15025 once daily (orally) as monotherapy in sequential cohorts of approximately 5 increasing doses for up to 6 months. In Phase 1a, Part B, participants will receive BGB-15025 once daily (orally) in sequential cohorts plus 200mg tislelizumab (intravenously) on day 1 of each 21-day cycle for up to 12 months. In Phase 1b (dose expansion) will begin based upon the recommended Phase 2 dose (RP2D) for BGB-15025 (orally) alone or in combination with tislelizumab (intravenously)as determined from Phase 1a.