A First-in-Human Study of BG-C137, an Anti-FGFR2b Antibody Drug Conjugate, in Participants With Advanced Solid Tumors

Last updated: April 10, 2025
Sponsor: BeiGene
Overall Status: Active - Recruiting

Phase

1

Condition

Neoplasms

Treatment

BG-C137

Clinical Study ID

NCT06625593
BG-C137-101
  • 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 in participants with advanced solid tumors.

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. SafetyExpansion and Dose Expansion: Participants who have received 1 or 2 prior lines ofsystemic therapy in the advanced or metastatic setting.

  4. Participants must provide agreement for collection of archival tissue or recentlyobtained fresh tumor biopsy for central evaluation of FGFR2b expression levels andother 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

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, keratoconjuntivitis, 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: 68
Treatment Group(s): 1
Primary Treatment: BG-C137
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 2148
    Australia

    Active - Recruiting

  • Liverpool Hospital

    Liverpool, New South Wales 2170
    Australia

    Active - Recruiting

  • Icon Cancer Centre South Brisbane

    South Brisbane, Queensland 4101
    Australia

    Active - Recruiting

  • Monash Health

    Clayton, Victoria 3168
    Australia

    Active - Recruiting

  • Cabrini Hospital Malvern

    Malvern, Victoria 3144
    Australia

    Site Not Available

  • Cabrini Hospital Malvern

    Malvern East, Victoria 3144
    Australia

    Active - Recruiting

  • Beijing Cancer Hospital

    Beijing, Beijing 100142
    China

    Active - Recruiting

  • Hubei Cancer Hospital

    Wuhan, Hubei 430079
    China

    Active - Recruiting

  • Affiliated Zhongshan Hospital of Fudan University

    Shanghai, Shanghai 200032
    China

    Active - Recruiting

  • Shanghai East Hospital Branch Hospital

    Shanghai, Shanghai 200123
    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

    Site Not Available

  • 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

    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

  • Seoul National University Bundang Hospital

    Seongnam-si, 13620
    Korea, Republic of

    Site Not Available

  • Usc Norris Comprehensive Cancer Center (Nccc)

    Los Angeles, California 90089-1019
    United States

    Active - Recruiting

  • Yale Cancer Center

    New Haven, Connecticut 06520-8028
    United States

    Active - Recruiting

  • Mayo Clinic Rochester

    Rochester, Minnesota 55905-0001
    United States

    Active - Recruiting

  • 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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