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A First-in-Human Study of BG-C0902 Alone and in Combination With Other Therapeutic Agents in Patients With Advanced Solid Tumors
Sponsor: BeOne Medicines
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).
Official title: A Phase 1a/b Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BG-C0902, an Antibody-Drug Conjugate Targeting Epidermal Growth Factor Receptor (EGFR) × Mesenchymal-Epithelial Transition (MET), Alone and in Combination With Other Therapeutic Agents in Patients With Advanced Solid Tumors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
63
Start Date
2025-11-10
Completion Date
2027-11-01
Last Updated
2026-02-23
Healthy Volunteers
No
Conditions
Interventions
BG-C0902
Administered by intravenous infusion
Locations (8)
The University of Texas Md Anderson Cancer Center
Houston, Texas, United States
Next Oncology
San Antonio, Texas, United States
Next Virginia
Fairfax, Virginia, United States
Blacktown Cancer and Haematology Centre
Blacktown, New South Wales, Australia
Monash Health
Clayton, Victoria, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China