Study of BG-C137 for Advanced Solid Tumors
This study is testing a new treatment called BG-C137, an antibody-drug conjugate (a targeted therapy that delivers a drug directly to cancer cells), for people with advanced solid tumors. Researchers want to see how safe BG-C137 is, how well your body handles it, and if it can shrink tumors, both when given alone and with other anti-cancer medicines. You might be able to join if you have advanced solid tumors that have been confirmed by a biopsy, are expected to live at least 3 months, and have already tried standard treatments. The study aims to enroll 168 participants and is currently in an unclear status regarding recruitment.
- Study design
- This study is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 168 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be monitored for adverse events for up to approximately 2 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
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
At a glance
Conditions
NCT06625593
Where you'd take part
This study runs at 52 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Affiliated Hospital of Jiangnan University South Campus
Wuxi, Jiangsu, Chinano site contact published
Recruiting
Affiliated Zhongshan Hospital of Fudan University
Shanghai, Shanghai Municipality, Chinano site contact published
Recruiting
Anhui Provincial Hospital
Hefei, Anhui, Chinano site contact published
Recruiting
Asan Medical Center
SongpaGu, Seoul Teugbyeolsi, South Koreano site contact published
Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, Chinano site contact published
Recruiting
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, Chinano site contact published
Recruiting
Blacktown Cancer and Haematology Centre
Blacktown, New South Wales, Australiano site contact published
Recruiting
Cabrini Hospital Malvern
Malvern, Victoria, Australiano site contact published
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Study Director · STUDY_DIRECTOR · BeOne Medicines
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)Up to approximately 2 years
Number of participants with AEs and SAEs as graded by the National Cancer Institute- Common Terminology Criteria for Adverse Events Version (NCI CTCAE 5.0)), including AEs that meet protocol-defined dose-limiting toxicity (DLT) criteria and AEs meeting protocol-defined adverse event of clinical interest (AECIs)
- Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BG-C137Up to approximately 2 years
The MTD or MAD is defined as the highest dose evaluated for which the estimated toxicity rate is closest to a target toxicity rate, or the highest dose administered, respectively.
- Phase 1a: Recommended Dose(s) for Expansion (RDFE[s]) of BG-C137 as monotherapy and in combination with anticancer agentsUp to approximately 2 years
RDFE(s) is determined based on relevant data, as available
- Phase 1b: The recommended Phase 2 dose (RP2D) of BG-C137Up to approximately 2 years
The RP2D of BG-C137 monotherapy will be determined based on relevant data, as available
- Phase 1b: Overall Response Rate (ORR)Up to approximately 2 years
ORR is defined as the percentage of participants with confirmed complete response (CR) or partial response (PR) by Response Evaluations Criteria in Solid Tumors Version 1.1 (RECIST v1.1)