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
Condition(s) studied
Investigational drug(s) / intervention(s)
BG-C137: Administered intravenously
Anticancer Agents: Administered intravenously or orally
Study 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).
Eligibility
Primary outcome measure(s)
- 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-C137 — Up 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 agents — Up to approximately 2 years
RDFE(s) is determined based on relevant data, as available - Phase 1b: The recommended Phase 2 dose (RP2D) of BG-C137 — Up 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)
Trial sites (52)
| Facility | City | Region | Status |
|---|---|---|---|
| Usc Norris Comprehensive Cancer Center (Nccc) | Los Angeles | California | Recruiting |
| Yale Cancer Center | New Haven | Connecticut | Recruiting |
| Mayo Clinic Rochester | Rochester | Minnesota | Completed |
| Md Anderson Cancer Center | Houston | Texas | Recruiting |
| Fred Hutchinson Cancer Research Center | Seattle | Washington | Recruiting |
| University of Wisconsin | Madison | Wisconsin | Recruiting |
| Blacktown Cancer and Haematology Centre | Blacktown | New South Wales | Recruiting |
| Liverpool Hospital | Liverpool | New South Wales | Recruiting |
| Icon Cancer Centre South Brisbane | South Brisbane | Queensland | Recruiting |
| Monash Health | Clayton | Victoria | Recruiting |
| Cabrini Hospital Malvern | Malvern | Victoria | Recruiting |
| The First Affiliated Hospital of Bengbu Medical University | Bengbu | Anhui | Recruiting |
| Anhui Provincial Hospital | Hefei | Anhui | Recruiting |
| The Second Hospital of Anhui Medical University | Hefei | Anhui | Recruiting |
| Beijing Friendship Hospital, Capital Medical University | Beijing | Beijing Municipality | Recruiting |
| Beijing Cancer Hospital | Beijing | Beijing Municipality | Recruiting |
| Fujian Medical University Union Hospital | Fuzhou | Fujian | Recruiting |
| The First Affiliated Hospital of Xiamen University | Xiamen | Fujian | Recruiting |
| Zhongshan Hospital Xiamen University | Xiamen | Fujian | Recruiting |
| Guangxi Medical University Cancer Hospital Wuxiang Branch | Nanning | Guangxi | Recruiting |
| The Fourth Hospital of Hebei Medical University | Shijiazhuang | Hebei | Recruiting |
| Harbin Medical University Cancer Hospital | Harbin | Heilongjiang | Recruiting |
| The First Affiliated Hospital of Henan University of Science and Technology | Luoyang | Henan | Recruiting |
| The First Affiliated Hospital of Xinxiang Medical University | Xinxiang | Henan | Recruiting |
| Henan Cancer Hospital | Zhengzhou | Henan | Recruiting |
| Hubei Cancer Hospital | Wuhan | Hubei | Recruiting |
| Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School | Nanjing | Jiangsu | Recruiting |
| Jiangsu Province Hospital | Nanjing | Jiangsu | Recruiting |
| Affiliated Hospital of Jiangnan University South Campus | Wuxi | Jiangsu | Recruiting |
| The Affiliated Hospital of Xuzhou Medical University Kunpeng Road Branch | Xuzhou | Jiangsu | Recruiting |
| Liaoning Cancer Hospital and Institute | Shenyang | Liaoning | Recruiting |
| The First Affiliated Hospital of Xian Jiaotong University | Xi'an | Shaanxi | Recruiting |
| Shandong Cancer Hospital | Jinan | Shandong | Recruiting |
| The Affiliated Hospital of Qingdao University Branch North | Qingdao | Shandong | Recruiting |
| The Second Affiliated Hospital of Shandong First Medical University | Taian | Shandong | Recruiting |
| Weifang Peoples Hospital Beichen Branch | Weifang | Shandong | Recruiting |
| Affiliated Zhongshan Hospital of Fudan University | Shanghai | Shanghai Municipality | Recruiting |
| Fudan University Shanghai Cancer Centerpudong | Shanghai | Shanghai Municipality | Recruiting |
| Heping Hospital Affiliated to Changzhi Medical College | Changzhi | Shanxi | Recruiting |
| Shanxi Provincial Cancer Hospital | Taiyuan | Shanxi | Recruiting |
+ 12 more sites — see the full list on the official registry below.
More BeOne Medicines trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06625593 on ClinicalTrials.gov ↗ ← All trials in China