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Recruiting Phase 1

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 · tracked via the Priya Life Science China tracker
Phase
Phase 1
Started
2024-12-09
Last updated
2026-07-09

Condition(s) studied

Advanced Solid Tumor

Investigational drug(s) / intervention(s)

BG-C137Anticancer Agents

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Histologically or cytologically confirmed advanced or metastatic solid tumors. 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: 1. Prior exposure to topoisomerase I inhibitor (TOP1i)-based antibody-drug conjugate (ADC) therapies or FGFR2b-targeted ADC therapies. 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. Note: Other protocol-defined Inclusion/Exclusion criteria may apply.

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)

FacilityCityRegionStatus
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.

Official registry record

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