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RECRUITING

NCT06625593

PHASE1

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

Sponsor: BeOne Medicines

View on ClinicalTrials.gov

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).

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

168

Start Date

2024-12-09

Completion Date

2026-12-31

Last Updated

2026-05-29

Healthy Volunteers

Conditions

Advanced Solid Tumor

Interventions

DRUG

BG-C137

Administered intravenously

DRUG

Anticancer Agents

Administered intravenously or orally

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.

Locations (53)

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, Victoria, Australia

The First Affiliated Hospital of Bengbu Medical University

Bengbu, Anhui, China

Anhui Provincial Hospital

Hefei, Anhui, China

The Second Hospital of Anhui Medical University

Hefei, Anhui, China

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

Zhongshan Hospital Xiamen University

Xiamen, Fujian, China

The Tumor Hospital Affiliated to Guangxi Medical Universitywuxiang Branch

Nanning, Guangxi, China

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, China

The First Affiliated Hospital of Xinxiang Medical University

Xinxiang, Henan, China

Henan Cancer Hospital

Zhengzhou, Henan, China

Hubei Cancer Hospital

Wuhan, Hubei, China

Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School

Nanjing, Jiangsu, China

Jiangsu Province Hospital

Nanjing, Jiangsu, China

Affiliated Hospital of Jiangnan University South Campus

Wuxi, Jiangsu, China

The Affiliated Hospital of Xuzhou Medical University Kunpeng Road Branch

Xuzhou, Jiangsu, China

Liaoning Cancer Hospital and Institute

Shenyang, Liaoning, China

The First Affiliated Hospital of Xian Jiaotong University

Xi'an, Shaanxi, China

Shandong Cancer Hospital

Jinan, Shandong, China

The Affiliated Hospital of Qingdao University Branch North

Qingdao, Shandong, China

The Second Affiliated Hospital of Shandong First Medical University

Taian, Shandong, China

Weifang Peoples Hospital Beichen Branch

Weifang, Shandong, China

Affiliated Zhongshan Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Shanghai East Hospital Branch Hospital

Shanghai, Shanghai Municipality, China

Fudan University Shanghai Cancer Centerpudong

Shanghai, Shanghai Municipality, China

Heping Hospital Affiliated to Changzhi Medical College

Changzhi, Shanxi, China

Shanxi Provincial Cancer Hospital

Taiyuan, Shanxi, China

Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital

Chengdu, Sichuan, China

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Cha Bundang Medical Center, Cha University

BundangGu SeongnamSi, Gyeonggi-do, South Korea

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Kyungpook National University Chilgok Hospital

BukGu, Gyeongsangbukdo, South Korea

Gachon University Gil Medical Center

NamdongGu, Incheon Gwang'yeogsi, 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

Gangnam Severance Hospital, Yonsei University Health System

Seoul, Seoul Teugbyeolsi, South Korea

Asan Medical Center

SongpaGu, Seoul Teugbyeolsi, South Korea

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (53)