Phase 1 Study of BPI-371153 to Test Safety and Dose in Advanced Solid Tumors and Relapsed or Refractory Lymphoma

What this Trial Is About

Researchers are evaluating the safety, tolerability, and maximum tolerated dose of BPI-371153, a PD-L1 inhibitor, in patients with advanced solid tumors or relapsedrefractory lymphoma. This phase 1 open-label study aims to establish the recommended dose for further research and to understand how the drug behaves in the body and its anti-tumor activity. Participants will receive oral capsules of BPI-371153 once daily in 21-day treatment cycles. The study includes a dose escalation phase to find the maximum tolerated dose and a dose expansion phase where patients receive the recommended dose. Different patient groups include those with advanced non-small cell lung cancer, relapsed or refractory lymphoma, hepatocellular carcinoma, and other advanced solid tumors. During the study, participants will be monitored for adverse events, drug levels in the body, and tumor response over approximately 24 months. Researchers will assess tumor lesions using recognized criteria and evaluate PD-L1 expression levels. The study requires adequate organ function and performance status, with ongoing evaluation to ensure safety and determine the best dose for future studies.

A Phase 1 Study of BPI-371153 in Subjects with Advanced Solid Tumors or Relapsed/Refractory Lymphoma