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: November 20, 2025
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

Connect with a study center

  • Blacktown Cancer and Haematology Centre

    Blacktown, New South Wales NSW 2148
    Australia

    Site Not Available

  • Liverpool Hospital

    Liverpool, New South Wales NSW 2170
    Australia

    Site Not Available

  • Blacktown Cancer and Haematology Centre

    Blacktown 2175411, New South Wales 2155400 NSW 2148
    Australia

    Active - Recruiting

  • Liverpool Hospital

    Liverpool 2159851, New South Wales 2155400 NSW 2170
    Australia

    Active - Recruiting

  • Icon Cancer Centre South Brisbane

    South Brisbane, Queensland QLD 4101
    Australia

    Site Not Available

  • Icon Cancer Centre South Brisbane

    South Brisbane 2207259, Queensland 2152274 QLD 4101
    Australia

    Active - Recruiting

  • Monash Health

    Clayton, Victoria VIC 3168
    Australia

    Site Not Available

  • Cabrini Hospital Malvern

    Malvern, Victoria 3144
    Australia

    Site Not Available

  • Cabrini Hospital Malvern

    Malvern East, Victoria VIC 3144
    Australia

    Site Not Available

  • Monash Health

    Clayton 2171400, Victoria 2145234 VIC 3168
    Australia

    Active - Recruiting

  • Cabrini Hospital Malvern

    Malvern East 7932638, Victoria 2145234 VIC 3144
    Australia

    Active - Recruiting

  • Beijing Cancer Hospital

    Beijing, Beijing 100142
    China

    Site Not Available

  • Beijing Cancer Hospital

    Beijing 1816670, Beijing Municipality 2038349 100142
    China

    Active - Recruiting

  • The Tumor Hospital Affiliated to Guangxi Medical Universitywuxiang Branch

    Nanning 1799869, Guangxi 1809867 530201
    China

    Active - Recruiting

  • Harbin Medical University Cancer Hospital

    Harbin 2037013, Heilongjiang 2036965 150000
    China

    Active - Recruiting

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

    Luoyang 1801792, Henan 1808520 471003
    China

    Active - Recruiting

  • Henan Cancer Hospital

    Zhengzhou 1784658, Henan 1808520 450000
    China

    Active - Recruiting

  • Hubei Cancer Hospital

    Wuhan, Hubei 430079
    China

    Site Not Available

  • Hubei Cancer Hospital

    Wuhan 1791247, Hubei 1806949 430079
    China

    Active - Recruiting

  • Affiliated Hospital of Jiangnan University South Campus

    Wuxi 1790923, Jiangsu 1806260 214122
    China

    Active - Recruiting

  • The Affiliated Hospital of Qingdao University Branch North

    Qingdao, Shandong 266000
    China

    Site Not Available

  • The Affiliated Hospital of Qingdao University Branch North

    Qingdao 1797929, Shandong 1796328 266000
    China

    Active - Recruiting

  • Affiliated Zhongshan Hospital of Fudan University

    Shanghai, Shanghai 200032
    China

    Site Not Available

  • Shanghai East Hospital Branch Hospital

    Shanghai, Shanghai 200123
    China

    Active - Recruiting

  • Affiliated Zhongshan Hospital of Fudan University

    Shanghai 1796236, Shanghai Municipality 1796231 200032
    China

    Active - Recruiting

  • Shanghai East Hospital Branch Hospital

    Shanghai 1796236, Shanghai Municipality 1796231 200123
    China

    Active - Recruiting

  • Shanxi Provincial Cancer Hospital

    Taiyuan 1793511, Shanxi 1795912 030013
    China

    Active - Recruiting

  • National Cancer Center Hospital East

    Kashiwa 1859924, Chiba 2113014 277-8577
    Japan

    Site Not Available

  • National Cancer Center Hospital

    ChuoKu, Tokyo 1850144 104-0045
    Japan

    Site Not Available

  • Cancer Institute Hospital of Jfcr

    Kotoku, Tokyo 1850144 135-8550
    Japan

    Site Not Available

  • 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

  • Seoul National University Hospital

    Seoul, Seoul Teugbyeolsi 03080
    Korea, Republic of

    Site Not Available

  • 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

  • Seoul National University Bundang Hospital

    Seongnam-si, 13620
    Korea, Republic of

    Site Not Available

  • 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

    Site Not Available

  • Gachon University Gil Medical Center

    NamdongGu, Incheon Gwang'yeogsi 21565
    South Korea

    Site Not Available

  • 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 1835848, Seoul Teugbyeolsi 06273
    South Korea

    Site Not Available

  • 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

    Site Not Available

  • Usc Norris Comprehensive Cancer Center (Nccc)

    Los Angeles 5368361, California 5332921 90089-1019
    United States

    Active - Recruiting

  • Yale Cancer Center

    New Haven, Connecticut 06520-8028
    United States

    Site Not Available

  • Yale Cancer Center

    New Haven 4839366, Connecticut 4831725 06520-8028
    United States

    Active - Recruiting

  • Mayo Clinic Rochester

    Rochester, Minnesota 55905-0001
    United States

    Site Not Available

  • Mayo Clinic Rochester

    Rochester 5043473, Minnesota 5037779 55905-0001
    United States

    Active - Recruiting

  • Md Anderson Cancer Center

    Houston, Texas 77030-3907
    United States

    Site Not Available

  • Md Anderson Cancer Center

    Houston 4699066, Texas 4736286 77030-3907
    United States

    Active - Recruiting

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington 98109-4433
    United States

    Site Not Available

  • Fred Hutchinson Cancer Research Center

    Seattle 5809844, Washington 5815135 98109-4433
    United States

    Active - Recruiting

  • University of Wisconsin

    Madison, Wisconsin 53792-0001
    United States

    Site Not Available

  • University of Wisconsin

    Madison 5261457, Wisconsin 5279468 53792-0001
    United States

    Active - Recruiting

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