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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
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
Conditions
Interventions
BG-C137
Administered intravenously
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