Actively Recruiting
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
Led by BeOne Medicines · Updated on 2026-05-11
168
Participants Needed
52
Research Sites
107 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed advanced or metastatic solid tumors.
- Life expectancy of at least 3 months.
- Prior standard systemic therapy in the advanced or metastatic setting.
- For dose escalation: further standard treatment is not available, not tolerated, or inappropriate per investigator judgment.
- For combination and dose expansion groups: received at least 1 or 2 prior lines of systemic therapy including fluoropyrimidine and/or platinum.
- Tumors with FGFR2b expression or FGFR2 gene amplification.
- Agreement to provide archival or fresh tumor tissue for biomarker assessment.
- At least one measurable lesion per RECIST v1.1.
- ECOG Performance Status of 0 or 1.
- Adequate organ function as per study protocol.
You will not qualify if you...
- Prior exposure to topoisomerase I inhibitor-based or FGFR2b-targeted antibody-drug conjugate therapies.
- Active or chronic corneal disorders or clinically significant corneal disease preventing adequate monitoring.
- Spinal cord compression, active leptomeningeal disease, or uncontrolled/untreated brain metastases.
- Systemic antitumor therapy within 14 days before first study dose (28 days for immuno-oncological antibodies; 14 days or 5 half-lives for chemotherapy, ADCs, or investigational therapy).
- Toxicities from prior therapy not resolved.
- Any malignancy within 2 years before first study dose, except the cancer under study or treated locally recurring cancer.
- History of interstitial lung disease, noninfectious pneumonitis, oxygen saturation below 92% at rest, or need for supplemental oxygen at baseline.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 52 locations
1
Usc Norris Comprehensive Cancer Center (Nccc)
Los Angeles, California, United States, 90089-1019
Actively Recruiting
2
Yale Cancer Center
New Haven, Connecticut, United States, 06510
Actively Recruiting
3
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905-0001
Completed
4
Md Anderson Cancer Center
Houston, Texas, United States, 77030-3907
Actively Recruiting
5
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-4433
Actively Recruiting
6
University of Wisconsin
Madison, Wisconsin, United States, 53792-0001
Actively Recruiting
7
Blacktown Cancer and Haematology Centre
Blacktown, New South Wales, Australia, NSW 2148
Actively Recruiting
8
Liverpool Hospital
Liverpool, New South Wales, Australia, NSW 2170
Actively Recruiting
9
Icon Cancer Centre South Brisbane
South Brisbane, Queensland, Australia, QLD 4101
Actively Recruiting
10
Monash Health
Clayton, Victoria, Australia, VIC 3168
Actively Recruiting
11
Cabrini Hospital Malvern
Malvern East, Victoria, Australia, VIC 3144
Actively Recruiting
12
The First Affiliated Hospital of Bengbu Medical University
Bengbu, Anhui, China, 233004
Actively Recruiting
13
Anhui Provincial Hospital
Hefei, Anhui, China, 230000
Actively Recruiting
14
The Second Hospital of Anhui Medical University
Hefei, Anhui, China, 230601
Actively Recruiting
15
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100050
Actively Recruiting
16
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
17
Fujian Medical University Union Hospital
Fuzhou, Fujian, China, 350001
Actively Recruiting
18
Zhongshan Hospital Xiamen University
Xiamen, Fujian, China, 361004
Actively Recruiting
19
The Tumor Hospital Affiliated to Guangxi Medical Universitywuxiang Branch
Nanning, Guangxi, China, 530201
Actively Recruiting
20
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China, 050011
Actively Recruiting
21
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China, 150000
Actively Recruiting
22
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China, 471003
Actively Recruiting
23
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, China, 453100
Actively Recruiting
24
Henan Cancer Hospital
Zhengzhou, Henan, China, 450000
Actively Recruiting
25
Hubei Cancer Hospital
Wuhan, Hubei, China, 430079
Actively Recruiting
26
Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China, 210008
Actively Recruiting
27
Jiangsu Province Hospital
Nanjing, Jiangsu, China, 210029
Actively Recruiting
28
Affiliated Hospital of Jiangnan University South Campus
Wuxi, Jiangsu, China, 214122
Actively Recruiting
29
The Affiliated Hospital of Xuzhou Medical University Kunpeng Road Branch
Xuzhou, Jiangsu, China, 221000
Actively Recruiting
30
Liaoning Cancer Hospital and Institute
Shenyang, Liaoning, China, 110042
Actively Recruiting
31
The First Affiliated Hospital of Xian Jiaotong University
Xi'an, Shaanxi, China, 710061
Actively Recruiting
32
Shandong Cancer Hospital
Jinan, Shandong, China, 250117
Actively Recruiting
33
The Affiliated Hospital of Qingdao University Branch North
Qingdao, Shandong, China, 266000
Actively Recruiting
34
The Second Affiliated Hospital of Shandong First Medical University
Taian, Shandong, China, 271099
Actively Recruiting
35
Weifang Peoples Hospital Beichen Branch
Weifang, Shandong, China, 261057
Actively Recruiting
36
Affiliated Zhongshan Hospital of Fudan University
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
37
Shanghai East Hospital Branch Hospital
Shanghai, Shanghai Municipality, China, 200123
Actively Recruiting
38
Fudan University Shanghai Cancer Centerpudong
Shanghai, Shanghai Municipality, China, 201321
Actively Recruiting
39
Heping Hospital Affiliated to Changzhi Medical College
Changzhi, Shanxi, China, 046000
Actively Recruiting
40
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, China, 030013
Actively Recruiting
41
Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
Chengdu, Sichuan, China, 610071
Actively Recruiting
42
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China, 300060
Actively Recruiting
43
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022
Actively Recruiting
44
Cha Bundang Medical Center, Cha University
BundangGu SeongnamSi, Gyeonggi-do, South Korea, 13496
Actively Recruiting
45
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea, 13620
Actively Recruiting
46
Kyungpook National University Chilgok Hospital
BukGu, Gyeongsangbukdo, South Korea, 41404
Actively Recruiting
47
Gachon University Gil Medical Center
NamdongGu, Incheon Gwang'yeogsi, South Korea, 21565
Actively Recruiting
48
Samsung Medical Center
GangnamGu, Seoul Teugbyeolsi, South Korea, 06351
Actively Recruiting
49
Severance Hospital Yonsei University Health System
SeodaemunGu, Seoul Teugbyeolsi, South Korea, 03722
Actively Recruiting
50
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, South Korea, 03080
Actively Recruiting
51
Gangnam Severance Hospital, Yonsei University Health System
Seoul, Seoul Teugbyeolsi, South Korea, 06273
Actively Recruiting
52
Asan Medical Center
SongpaGu, Seoul Teugbyeolsi, South Korea, 05505
Actively Recruiting
Research Team
S
Study Director
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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