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Phase 1 Study Investigating the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of the Anti OX40 Agonist Monoclonal Antibody BGB-A445 in Combination With the Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients With Advanced Solid Tumors
BeiGene Australia Pty Ltd
This is a dose escalation and expansion study. In the dose escalation phase (Phase Ia), eligible patients will receive intravenous BGB-A445 as a monotherapy in sequential cohorts of approximately 5 increasing dose levels on day 1 of each 21 day treatment cycle, OR receive BGB-A445 in combination with tislelizumab in sequential cohorts of approximately 3 increasing dose levels on day 1 of each 21 day treatment cycle. In the dose expansion phase (Phase Ib), eligible patients will receive a recommended Phase 2 does of intravenous BGB-A445 alone or in combination with tislelizumab as determined by the dose escalation phase.