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
NCT06625593 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 168
Last updated 2026-05-11
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).
Conditions
- Advanced Solid Tumor
Interventions
- DRUG
-
BG-C137
Administered intravenously
- DRUG
-
Anticancer Agents
Administered intravenously or orally
Sponsors & Collaborators
-
BeOne Medicines
lead INDUSTRY
Principal Investigators
-
Study Director · BeOne Medicines
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-12-09
- Primary Completion
- 2026-12-31
- Completion
- 2026-12-31
- FDA Drug
- Yes
Countries
- United States
- Australia
- China
- South Korea
Study Locations
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