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RECRUITING
NCT06625593
PHASE1

A First-in-Human (FIH) Study of BG-C137, an Anti-Fibroblast Growth Factor Receptor 2b (FGFR2b) Antibody Drug Conjugate, in Participants With Advanced Solid Tumors

Sponsor: BeOne Medicines

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BG-C137 alone and in combination with anticancer agents in participants with advanced solid tumors. The study will be conducted in two phases: Phase 1a (Monotherapy Dose Escalation, and Safety Expansion; Combination Dose Confirmation and Safety Expansion) and Phase 1b (Dose Expansion).

Official title: A Phase 1a/b, Open-label, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BG-C137, an Antibody-Drug Conjugate Targeting FGFR2b, in Patients With Advanced Solid Tumors

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

168

Start Date

2024-12-09

Completion Date

2026-12-31

Last Updated

2026-02-20

Healthy Volunteers

No

Interventions

DRUG

BG-C137

Administered intravenously

DRUG

Anticancer Agents

Administered intravenously or orally

Locations (31)

Usc Norris Comprehensive Cancer Center (Nccc)

Los Angeles, California, United States

Yale Cancer Center

New Haven, Connecticut, United States

Mayo Clinic Rochester

Rochester, Minnesota, United States

Md Anderson Cancer Center

Houston, Texas, United States

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

University of Wisconsin

Madison, Wisconsin, United States

Blacktown Cancer and Haematology Centre

Blacktown, New South Wales, Australia

Liverpool Hospital

Liverpool, New South Wales, Australia

Icon Cancer Centre South Brisbane

South Brisbane, Queensland, Australia

Monash Health

Clayton, Victoria, Australia

Cabrini Hospital Malvern

Malvern East, Victoria, Australia

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

The Tumor Hospital Affiliated to Guangxi Medical Universitywuxiang Branch

Nanning, Guangxi, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, China

Henan Cancer Hospital

Zhengzhou, Henan, China

Hubei Cancer Hospital

Wuhan, Hubei, China

Affiliated Hospital of Jiangnan University South Campus

Wuxi, Jiangsu, China

The Affiliated Hospital of Qingdao University Branch North

Qingdao, Shandong, China

Affiliated Zhongshan Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Shanghai East Hospital Branch Hospital

Shanghai, Shanghai Municipality, China

Shanxi Provincial Cancer Hospital

Taiyuan, Shanxi, China

Cha Bundang Medical Center, Cha University

BundangGu SeongnamSi, Gyeonggi-do, South Korea

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Kyungpook National University Chilgok Hospital

BukGu, Gyeongsangbukdo, South Korea

Gachon University Gil Medical Center

NamdongGu, Incheon Gwang'yeogsi, South Korea

Samsung Medical Center

GangnamGu, Seoul Teugbyeolsi, South Korea

Severance Hospital Yonsei University Health System

SeodaemunGu, Seoul Teugbyeolsi, South Korea

Seoul National University Hospital

Seoul, Seoul Teugbyeolsi, South Korea

Gangnam Severance Hospital, Yonsei University Health System

Seoul, Seoul Teugbyeolsi, South Korea

Asan Medical Center

SongpaGu, Seoul Teugbyeolsi, South Korea