drugset / Trial / NCT07181681

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

NCT07181681 ↗

Phase 1 Recruiting 63 enrolled BeOne Medicines
Non-randomizedSequentialOpen-labelTreatment

Summary

This study is a first-in-human (FIH), Phase 1a/1b study of BG-C0902, a fully humanized anti-epidermal growth factor receptor (EGFR) and anti-mesenchymal-epithelial transition (MET) antibody, conjugated via an enzymatically cleavable linker to a topoisomerase 1 (TOPO1) inhibitor payload. The study aims to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BG-C0902 in participants with advanced solid tumors. The study will be conducted in 2 phases: Phase 1a (dose escalation and safety expansion) and Phase 1b (dose expansion).

Timeline

Start
2025-11-10
Primary completion
2027-11-01
Completion
2027-11-01

Drugs

EvaluationDrugModalityDoseRoute
Subject BG-C0902 Monoclonal antibody — Intravenous

Indications