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

Last updated: July 8, 2026
Sponsor: BeOne Medicines
Overall Status: Active - Recruiting

Phase

1

Condition

Neoplasms

Treatment

Anticancer Agents

BG-C137

Clinical Study ID

NCT06625593
BG-C137-101
CTR20244835
2025-523572-23-00
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

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. DoseEscalation: Participants for whom further standard treatment is not available, nottolerated or determined not appropriate based on the investigator's judgment. ComboDose Confirmation, Combo Safety Expansion, and Dose Expansion: Participants who havereceived at least 1 or 2 prior lines of systemic therapy, which included afluoropyrimidine and/or a platinum in the advanced or metastatic setting

  4. Tumors with FGFR2b expression/ or FGFR2 gene amplification. Participants mustprovide agreement for collection of archival tissue or recently obtained fresh tumorbiopsy for central evaluation of FGFR2b expression levels and other biomarkerassessments.

  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

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, cornealkeratitis, keratoconjunctivitis, keratopathy, corneal abrasion, inflammation orulceration, other active ocular conditions and any clinically significant cornealdisease that prevents adequate monitoring of drug-induced keratopathy.

  3. Spinal cord compression, or active leptomeningeal disease or uncontrolled, untreatedbrain 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 isshorter] for chemotherapy, ADCs, or investigational therapy) before first dose ofstudy 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 specificcancer under investigation in this study and any locally recurring cancer that hasbeen treated curatively.

  7. History of interstitial lung disease (ILD), noninfectious pneumonitis, oxygensaturation at rest < 92%, or requirement for supplemental oxygen at baseline.

Note: Other protocol-defined Inclusion/Exclusion criteria may apply.

Study Design

Total Participants: 168
Treatment Group(s): 2
Primary Treatment: Anticancer Agents
Phase: 1
Study Start date:
December 09, 2024
Estimated Completion Date:
December 31, 2026

Study Description

Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.

Connect with a study center

  • Blacktown Cancer and Haematology Centre

    Blacktown, New South Wales NSW 2148
    Australia

    Active - Recruiting

  • Liverpool Hospital

    Liverpool, New South Wales NSW 2170
    Australia

    Active - Recruiting

  • Icon Cancer Centre South Brisbane

    South Brisbane, Queensland QLD 4101
    Australia

    Active - Recruiting

  • Monash Health

    Clayton, Victoria VIC 3168
    Australia

    Active - Recruiting

  • Cabrini Hospital Malvern

    Malvern, Victoria VIC 3144
    Australia

    Active - Recruiting

  • Cabrini Hospital Malvern

    Malvern East, Victoria 3144
    Australia

    Active - Recruiting

  • The First Affiliated Hospital of Bengbu Medical University

    Bengbu, Anhui 233004
    China

    Active - Recruiting

  • Anhui Provincial Hospital

    Hefei, Anhui 230000
    China

    Active - Recruiting

  • The Second Hospital of Anhui Medical University

    Hefei, Anhui 230601
    China

    Active - Recruiting

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality 100142
    China

    Active - Recruiting

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing Municipality 100050
    China

    Active - Recruiting

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian 350001
    China

    Active - Recruiting

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian 361003
    China

    Active - Recruiting

  • Zhongshan Hospital Xiamen University

    Xiamen, Fujian 361004
    China

    Active - Recruiting

  • Guangxi Medical University Cancer Hospital Wuxiang Branch

    Nanning, Guangxi 530201
    China

    Active - Recruiting

  • The Tumor Hospital Affiliated to Guangxi Medical Universitywuxiang Branch

    Nanning, Guangxi 530201
    China

    Active - Recruiting

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang, Hebei 050011
    China

    Active - Recruiting

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang 150000
    China

    Active - Recruiting

  • The First Affiliated Hospital of Henan University of Science and Technology

    Luoyang, Henan 471003
    China

    Active - Recruiting

  • The First Affiliated Hospital of Xinxiang Medical University

    Xinxiang, Henan 453100
    China

    Active - Recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan 450000
    China

    Active - Recruiting

  • Hubei Cancer Hospital

    Wuhan, Hubei 430079
    China

    Active - Recruiting

  • Jiangsu Province Hospital

    Nanjing, Jiangsu 210029
    China

    Active - Recruiting

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

    Nanjing, Jiangsu 210008
    China

    Active - Recruiting

  • Affiliated Hospital of Jiangnan University South Campus

    Wuxi, Jiangsu 214122
    China

    Active - Recruiting

  • The Affiliated Hospital of Xuzhou Medical University Kunpeng Road Branch

    Xuzhou, Jiangsu 221000
    China

    Active - Recruiting

  • Liaoning Cancer Hospital and Institute

    Shenyang, Liaoning 110042
    China

    Active - Recruiting

  • The First Affiliated Hospital of Xian Jiaotong University

    Xi'an, Shaanxi 710061
    China

    Active - Recruiting

  • Shandong Cancer Hospital

    Jinan, Shandong 250117
    China

    Active - Recruiting

  • The Affiliated Hospital of Qingdao University Branch North

    Qingdao, Shandong 266000
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Shandong First Medical University

    Taian, Shandong 271099
    China

    Active - Recruiting

  • Weifang Peoples Hospital Beichen Branch

    Weifang, Shandong 261057
    China

    Active - Recruiting

  • Affiliated Zhongshan Hospital of Fudan University

    Shanghai, Shanghai Municipality 200032
    China

    Active - Recruiting

  • Fudan University Shanghai Cancer Centerpudong

    Shanghai, Shanghai Municipality 201321
    China

    Active - Recruiting

  • Shanghai East Hospital Branch Hospital

    Shanghai, Shanghai Municipality 200123
    China

    Active - Recruiting

  • Shanghai East Hospital Branch Hospital

    Shanghai 1796236, Shanghai Municipality 1796231 200123
    China

    Active - Recruiting

  • Heping Hospital Affiliated to Changzhi Medical College

    Changzhi, Shanxi 046000
    China

    Active - Recruiting

  • Shanxi Provincial Cancer Hospital

    Taiyuan, Shanxi 030013
    China

    Active - Recruiting

  • Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital

    Chengdu, Sichuan 610071
    China

    Active - Recruiting

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality 300060
    China

    Active - Recruiting

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang 310022
    China

    Active - Recruiting

  • Seoul National University Bundang Hospital

    BundangGu SeongnamSi, Gyeonggi-do 13620
    Korea, Republic of

    Active - Recruiting

  • Samsung Medical Center

    GangnamGu, Seoul Teugbyeolsi 06351
    Korea, Republic of

    Active - Recruiting

  • Severance Hospital Yonsei University Health System

    SeodaemunGu, Seoul Teugbyeolsi 03722
    Korea, Republic of

    Active - Recruiting

  • Severance Hospital Yonsei University Health System

    Seoul, Seoul Teugbyeolsi 03722
    Korea, Republic of

    Active - Recruiting

  • Asan Medical Center

    SongpaGu, Seoul Teugbyeolsi 05505
    Korea, Republic of

    Active - Recruiting

  • Cha Bundang Medical Center, Cha University

    BundangGu SeongnamSi, Gyeonggi-do 13496
    South Korea

    Active - Recruiting

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do 13620
    South Korea

    Active - Recruiting

  • Seoul National University Bundang Hospital

    BundangGu SeongnamSi, Gyeonggi-do 1841610 13620
    South Korea

    Active - Recruiting

  • Kyungpook National University Chilgok Hospital

    BukGu, Gyeongsangbukdo 41404
    South Korea

    Active - Recruiting

  • Gachon University Gil Medical Center

    NamdongGu, Incheon Gwang'yeogsi 21565
    South Korea

    Active - Recruiting

  • Samsung Medical Center

    GangnamGu, Seoul Teugbyeolsi 06351
    South Korea

    Active - Recruiting

  • Severance Hospital Yonsei University Health System

    SeodaemunGu, Seoul Teugbyeolsi 03722
    South Korea

    Active - Recruiting

  • Gangnam Severance Hospital, Yonsei University Health System

    Seoul, Seoul Teugbyeolsi 06273
    South Korea

    Active - Recruiting

  • Seoul National University Hospital

    Seoul, Seoul Teugbyeolsi 03080
    South Korea

    Active - Recruiting

  • Seoul National University Hospital

    Seoul 1835848, Seoul Teugbyeolsi 03080
    South Korea

    Active - Recruiting

  • Asan Medical Center

    SongpaGu, Seoul Teugbyeolsi 05505
    South Korea

    Active - Recruiting

  • Usc Norris Comprehensive Cancer Center (Nccc)

    Los Angeles, California 90089-1019
    United States

    Active - Recruiting

  • Yale Cancer Center

    New Haven, Connecticut 06510
    United States

    Active - Recruiting

  • Mayo Clinic Rochester

    Rochester, Minnesota 55905-0001
    United States

    Completed

  • Md Anderson Cancer Center

    Houston, Texas 77030-3907
    United States

    Active - Recruiting

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington 98109-4433
    United States

    Active - Recruiting

  • University of Wisconsin

    Madison, Wisconsin 53792-0001
    United States

    Active - Recruiting

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