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
NCT ID: NCT06625593
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
168 participants
INTERVENTIONAL
2024-12-09
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Phase 1a: Monotherapy Dose Escalation and Safety Expansion
Sequential cohorts of increasing dose levels of BG-C137 will be evaluated as monotherapy
BG-C137
Administered intravenously
Phase 1a: Combination Therapy Dose Confirmation and Safety Expansion
Sequential cohorts will be evaluated to confirm the safety levels of BG-C137 in combination with other anticancer agents at selected dose levels that have been determined to be safe in Monotherapy Dose Escalation
BG-C137
Administered intravenously
Anticancer Agents
Administered intravenously or orally
Phase 1b: Dose Expansion
Recommended Dose(s) of BG-C137 as determined from Ph1a will be evaluated in select indications
BG-C137
Administered intravenously
Interventions
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BG-C137
Administered intravenously
Anticancer Agents
Administered intravenously or orally
Eligibility Criteria
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Inclusion Criteria
2. Life expectancy of ≥ 3 months.
3. Prior standard systemic therapy in the advanced or metastatic setting. Dose Escalation: Participants for whom further standard treatment is not available, not tolerated or determined not appropriate based on the investigator's judgment. Combo Dose Confirmation, Combo Safety Expansion, and Dose Expansion: Participants who have received at least 1 or 2 prior lines of systemic therapy, which included a fluoropyrimidine and/or a platinum in the advanced or metastatic setting
4. Tumors with FGFR2b expression/ or FGFR2 gene amplification. Participants must provide agreement for collection of archival tissue or recently obtained fresh tumor biopsy for central evaluation of FGFR2b expression levels and other biomarker assessments.
5. ≥ 1 measurable lesion per RECIST v1.1.
6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
7. Adequate organ function as determined per protocol.
Exclusion Criteria
2. Active or chronic corneal disorder, history of corneal transplantation, corneal keratitis, keratoconjunctivitis, keratopathy, corneal abrasion, inflammation or ulceration, other active ocular conditions and any clinically significant corneal disease that prevents adequate monitoring of drug-induced keratopathy.
3. Spinal cord compression, or active leptomeningeal disease or uncontrolled, untreated brain metastasis.
4. Systemic antitumor therapy (including targeted therapy and immunotherapy ≤ 14 days, ≤ 28 days for immuno- oncological antibody, ≤ 14 days or 5 half-lives \[whichever is shorter\] for chemotherapy, ADCs, or investigational therapy) before first dose of study drug(s).
5. Toxicities due to prior therapy that have not recovered.
6. Any malignancy ≤ 2 years before first dose of study drug(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated curatively.
7. History of interstitial lung disease (ILD), noninfectious pneumonitis, oxygen saturation at rest \< 92%, or requirement for supplemental oxygen at baseline.
18 Years
ALL
No
Sponsors
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BeOne Medicines
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
BeOne Medicines
Locations
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Usc Norris Comprehensive Cancer Center (Nccc)
Los Angeles, California, United States
Yale Cancer Center
New Haven, Connecticut, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Md Anderson Cancer Center
Houston, Texas, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
University of Wisconsin
Madison, Wisconsin, United States
Blacktown Cancer and Haematology Centre
Blacktown, New South Wales, Australia
Liverpool Hospital
Liverpool, New South Wales, Australia
Icon Cancer Centre South Brisbane
South Brisbane, Queensland, Australia
Monash Health
Clayton, Victoria, Australia
Cabrini Hospital Malvern
Malvern East, Victoria, Australia
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
The Tumor Hospital Affiliated to Guangxi Medical Universitywuxiang Branch
Nanning, Guangxi, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Hubei Cancer Hospital
Wuhan, Hubei, China
Affiliated Hospital of Jiangnan University South Campus
Wuxi, Jiangsu, China
Affiliated Zhongshan Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Shanghai East Hospital Branch Hospital
Shanghai, Shanghai Municipality, China
Seoul National University Bundang Hospital
BundangGu SeongnamSi, Gyeonggi-do, South Korea
Samsung Medical Center
GangnamGu, Seoul Teugbyeolsi, South Korea
Severance Hospital Yonsei University Health System
SeodaemunGu, Seoul Teugbyeolsi, South Korea
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, South Korea
Asan Medical Center
SongpaGu, Seoul Teugbyeolsi, South Korea
Countries
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Central Contacts
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Other Identifiers
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2025-523572-23-00
Identifier Type: CTIS
Identifier Source: secondary_id
CTR20244835
Identifier Type: OTHER
Identifier Source: secondary_id
BG-C137-101
Identifier Type: -
Identifier Source: org_study_id