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 (NCT06625593)
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
🩺 Plain-English Summary (8th-Grade Level)
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).
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (8 items).
Location: Usc Norris Comprehensive Cancer Center (Nccc) — Los Angeles, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Prior exposure to topoisomerase I inhibitor (TOP1i)-based antibody-drug conjugate (ADC) therapies or FGFR2b-targeted ADC therapies.
- 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.
- Spinal cord compression, or active leptomeningeal disease or uncontrolled, untreated brain metastasis.
- 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).
- Toxicities due to prior therapy that have not recovered.
- 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.
- History of interstitial lung disease (ILD), noninfectious pneumonitis, oxygen saturation at rest \< 92%, or requirement for supplemental oxygen at baseline. Note: Other protocol-defined Inclusion/Exclusion criteria may apply.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (52 Sites)
Showing the first 25 of 52 sites.
- Usc Norris Comprehensive Cancer Center (Nccc) — Los Angeles, California
- Yale Cancer Center — New Haven, Connecticut
- Mayo Clinic Rochester — Rochester, Minnesota
- Md Anderson Cancer Center — Houston, Texas
- Fred Hutchinson Cancer Research Center — Seattle, Washington
- University of Wisconsin — Madison, Wisconsin
- Blacktown Cancer and Haematology Centre — Blacktown, New South Wales
- Liverpool Hospital — Liverpool, New South Wales
- Icon Cancer Centre South Brisbane — South Brisbane, Queensland
- Monash Health — Clayton, Victoria
- Cabrini Hospital Malvern — Malvern, Victoria
- The First Affiliated Hospital of Bengbu Medical University — Bengbu, Anhui
- Anhui Provincial Hospital — Hefei, Anhui
- The Second Hospital of Anhui Medical University — Hefei, Anhui
- Beijing Friendship Hospital, Capital Medical University — Beijing, Beijing Municipality
- Beijing Cancer Hospital — Beijing, Beijing Municipality
- Fujian Medical University Union Hospital — Fuzhou, Fujian
- The First Affiliated Hospital of Xiamen University — Xiamen, Fujian
- Zhongshan Hospital Xiamen University — Xiamen, Fujian
- Guangxi Medical University Cancer Hospital Wuxiang Branch — Nanning, Guangxi
- The Fourth Hospital of Hebei Medical University — Shijiazhuang, Hebei
- Harbin Medical University Cancer Hospital — Harbin, Heilongjiang
- The First Affiliated Hospital of Henan University of Science and Technology — Luoyang, Henan
- The First Affiliated Hospital of Xinxiang Medical University — Xinxiang, Henan
- Henan Cancer Hospital — Zhengzhou, Henan
📞 Contact the Study Coordinator
Phone: (877) 828-5568
Email: clinicaltrials@beonemed.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Advanced Solid Tumor
- Phase 1/2 Study of TU2218 Alone and in Combination With Checkpoint Inhibitors in Patients With Advanced Solid Tumors — San Antonio, Texas
- Study in Advanced Solid Tumor Patients — Boston, Massachusetts
- Study of Denikitug (GS-1811) Given Alone or With Zimberelimab in Adults With Advanced Solid Tumors — La Jolla, California
- JZP898 Intravenous Infusion as Monotherapy and Combination With Pembrolizumab in Adults With Advanced/Metastatic Solid Tumors — Encinitas, California
- Study BT7480-100 in Patients With Advanced Malignancies Associated With Nectin-4 Expression — Iowa City, Iowa
Explore by condition: All Advanced Solid Tumor clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.