Phase 1ab Study of BG-C0902 Antibody-Drug Conjugate Alone and With Other Treatments for Advanced Solid Tumors

What this Trial Is About

Researchers are evaluating BG-C0902, a new antibody-drug conjugate targeting the epidermal growth factor receptor EGFR and mesenchymal-epithelial transition MET in people with advanced solid tumors. This first-in-human Phase 1a1b study aims to assess the safety, tolerability, how the drug behaves in the body pharmacokinetics and pharmacodynamics, and early signs of its ability to fight tumors. The study is sponsored by BeOne Medicines and includes two phases dose escalation and safety expansion Phase 1a and dose expansion Phase 1b. Participants will receive BG-C0902 through intravenous infusion in doses that increase over time during Phase 1a to find the recommended dose for further study. In Phase 1b, this recommended dose will be tested in selected tumor types. The study does not use randomization or blinding and involves sequential patient groups receiving the drug alone or in combination with other treatments. During the study, participants will undergo evaluations for adverse events, dose limiting toxicities, and tumor responses over approximately two years. Researchers will monitor blood levels of the drug and related antibodies, assess tumor changes using standard criteria, and check overall health status. Safety and effectiveness measurements will be collected regularly, with follow-up to understand how well participants respond and tolerate the treatment over time.

A First-in-Human Study of BG-C0902 Alone and in Combination With Other Therapeutic Agents in Patients With Advanced Solid Tumors