A First-in-Human Study of BG-C0902 Alone and in Combination With Other Therapeutic Agents in Patients With Advanced Solid Tumors

Last updated: January 23, 2026
Sponsor: BeOne Medicines
Overall Status: Active - Recruiting

Phase

1

Condition

Solid Tumors

Treatment

BG-C0902

Clinical Study ID

NCT07181681
BG-C0902-101
  • Ages > 18
  • All Genders

Study Summary

This study is a first-in-human (FIH), Phase 1a/1b study of BG-C0902, a fully humanized anti-epidermal growth factor receptor (EGFR) and anti-mesenchymal-epithelial transition (MET) antibody, conjugated via an enzymatically cleavable linker to a topoisomerase 1 (TOPO1) inhibitor payload. The study aims to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BG-C0902 in participants with advanced solid tumors. The study will be conducted in 2 phases: Phase 1a (dose escalation and safety expansion) and Phase 1b (dose expansion).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants with histologically or cytologically confirmed advanced, metastatic, orunresectable solid tumors not amenable to therapy with curative intent or for whomtreatment is not available or not tolerated.

  • Participants must be able to provide archival tissue formalin-fixedparaffin-embedded (FFPE) block containing tumor tissue or approximately 10 to 15freshly cut unstained FFPE slides) or recently obtained fresh tumor biopsy samplesat screening.

  • Participants must have ≥ 1 measurable lesion as assessed by RECIST v1.1.

  • Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1, as assessed ≤ 14days before the first dose of study drug.

  • Adequate bone marrow and organ function as indicated by the following laboratoryvalues ≤ 14 days before the first dose of study drug

  • Female participants of childbearing potential must be willing to use a highlyeffective method of birth control for the duration of the study and for ≥ 7 monthsafter the last dose of study drug. They must also have a negative serum pregnancytest result ≤ 3 days before the first dose of study drug.

  • Nonsterile male participants must be willing to use a highly effective method ofbirth control and refrain from sperm donation for the duration of the study and for ≥ 4 months after the last dose of study drug.

Exclusion

Exclusion Criteria:

  • History of severe allergic reactions or hypersensitivity to BG-T187 or othermonoclonal antibodies, or to the active ingredient and excipients of the study drugor camptothecins.

  • For Phase 1a Part B Safety Expansion and Phase 1b only: Prior treatment with anEGFR-targeting ADC or mesenchymal-epithelial transition (MET)-targetingantibody-drug conjugate (ADC), or any ADC with topoisomerase I (TOPO1) inhibitorpayload.

  • Active leptomeningeal disease or uncontrolled, untreated brain metastasis.Participants with a history of treated and, at the time of screening, stable centralnervous system (CNS) metastases are eligible, provided they meet all the following:

  1. Brain imaging at screening shows no evidence of interim progression, isclinically stable for ≥ 4 weeks, and has no evidence of new brain metastases

  2. Have measurable disease and/or evaluable disease outside CNS

  3. No ongoing requirement for corticosteroids as therapy for CNS disease; offcorticosteroids ≥ 14 days before dosing with study drug; anticonvulsants at astable dose are allowed

  4. No stereotactic radiation or whole-brain radiation ≤ 14 days before the firstdose of study drug

  • History of interstitial lung disease (ILD), or ≥ Grade 2 noninfectious pneumonitis ≤ 2 years before the first dose of the study drug, or has current ILD/noninfectiouspneumonitis, or where suspected active ILD/noninfectious pneumonitis cannot be ruledout by imaging during screening.

  • Participants with active or chronic corneal disorder, including but not limited toSjögren's, Fuch's corneal dystrophy, 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.

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

Study Design

Total Participants: 63
Treatment Group(s): 1
Primary Treatment: BG-C0902
Phase: 1
Study Start date:
November 10, 2025
Estimated Completion Date:
November 01, 2027

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 2175411, New South Wales 2155400 NSW 2148
    Australia

    Active - Recruiting

  • The Alfred Hospital

    Melbourne 2158177, Victoria 2145234 VIC 3004
    Australia

    Active - Recruiting

  • Zhejiang Cancer Hospital

    Hangzhou 1808926, Zhejiang 1784764 310022
    China

    Active - Recruiting

  • Next Oncology

    Austin 4671654, Texas 4736286 78758
    United States

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.