Phase 1ab Study of BG-C0979 Alone or with Tislelizumab in Adults with Advanced Solid Tumors Evaluating Safety and Antitumor Effects

What this Trial Is About

Researchers are studying BG-C0979, a drug being evaluated alone or combined with tislelizumab in adults with advanced solid tumors. The study includes early phases to test safety, dosage, how the drug moves in the body, and initial anti-tumor effects. Participants have advanced, metastatic, or unresectable tumors, with some having prior treatments and others being treatment-naive depending on the study phase. Participants receive BG-C0979 through intravenous infusion in different doses during Phase 1a dose escalation and safety expansion. Later, Phase 1b includes dose optimization and expansion of BG-C0979 alone, as well as combination therapy with tislelizumab for select tumor types. The study evaluates increasing doses, determines recommended doses for future studies, and compares monotherapy with combination therapy. Participants undergo regular assessments including tumor measurements using RECIST criteria, performance status evaluation, blood tests, and monitoring for side effects over up to 24 months. Researchers track how the drug is processed in the body, adverse events, tumor response, progression, and survival. This includes frequent safety and laboratory monitoring during treatment to understand tolerability and impact on tumors.

A First-in-Human Study of BG-C0979 in Adults With Advanced Solid Tumors