FIH Study of BG-C137 in Patients With Advanced Solid Tumors
Research type
Research Study
Full 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
IRAS ID
1013239
Contact name
Rachel Million
Contact email
Sponsor organisation
BeOne Medicines Ltd.
Eudract number
2025-523572-23
Clinicaltrials.gov Identifier
Research summary
FGFR2b is overexpressed in some patients with advanced cancers . Alteration in signaling in the FGF/FGFR2 pathway (eg, overexpression of FGFR2b protein or amplification of FGFR2 gene) has been associated with cancers, and may suggest a worse prognosis. Targeting FGFR2b with a monoclonal antibody (mAb) has demonstrated antitumor activity in advanced cancers. Therefore, FGFR2b is an attractive tumor-associated antigen to target.
BG-C137 is a FGFR2b-targeting antibody-drug conjugate (ADC), which has an antibody linked to a drug that attaches to a protein in cancer cells called FGFR2b. Antibodies are proteins produced by the immune system which will fight off foreign or unwanted substances in your body. The drug that is linked to BG-C137 is called topoisomerase I (TOP1) inhibitor. TOP1 inhibitors are drugs that block the ability of cells to reproduce, including cancer cells. After BG-C137 attaches to cancer cells, it enters the cells and kills them without harming other cells.
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antitumor activity of BG-C137 alone and in combination with anticancer agents in patients with advanced solid tumours.
Study details include:
• The study will be conducted in two phases: Phase 1a (Mono Dose Escalation, and Safety Expansion; Combo Dose Confirmation and Safety Expansion) and Phase 1b (Dose Expansion).
• The study plans to enrol approximately 166 - 310 patients over the age of 18
• Phase 1a Safety Expansion, Phase 1b Part A Dose Optimization, if enrollment is simultaneously open for 2 or more dose levels, eligible patients may be randomized to one of the open cohorts. For Phase 1b Part A, randomization may be implemented with FGFR2b expression
• The treatment duration will be up to 24 months.
• The study duration will be approximately 35 months.
• The study will end approximately 12 months after the enrolment of the last patient.REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
26/NW/0071
Date of REC Opinion
9 Apr 2026
REC opinion
Further Information Unfavourable Opinion