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RECRUITING
NCT07181681
PHASE1

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

View on ClinicalTrials.gov

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

Interventions

DRUG

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