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NCT07181681From ClinicalTrials.govRecruiting

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

A Phase 1a/b Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BG-C0902, an Antibody-Drug Conjugate Targeting Epidermal Growth Factor Receptor (EGFR) × Mesenchymal-Epithelial Transition (MET), Alone and in Combination With Other Therapeutic Agents in Patients With Advanced Solid Tumors

  • Solid Tumors
  • Advanced Solid Tumor

At a glance

Phase
Phase 1
Study type
Interventional
Sponsor
BeOne Medicines
Enrolment target
63
Started
10 November 2025
Main results due
1 November 2027
Study sites
15
Registry updated
28 September 2026

Can you take part?

  • Aged 18 years and over.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
Inclusion Criteria:

* Participants with histologically or cytologically confirmed advanced, metastatic, or unresectable solid tumors not amenable to therapy with curative intent or for whom treatment is not available or not tolerated.
* Participants must be able to provide archival tissue formalin-fixed paraffin-embedded (FFPE) block containing tumor tissue or approximately 10 to 15 freshly cut unstained FFPE slides) or recently obtained fresh tumor biopsy samples at screening.
* Participants must have ≥ 1 measurable lesion as assessed by RECIST v1.1.
* Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1, as assessed ≤ 14 days before the first dose of study drug.
* Adequate bone marrow and organ function as indicated by the following laboratory values ≤ 14 days before the first dose of study drug
* Female participants of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study and for ≥ 7 months after the last dose of study drug. They must also have a negative serum pregnancy test result ≤ 3 days before the first dose of study drug.
* Nonsterile male participants must be willing to use a highly effective method of birth control and refrain from sperm donation for the duration of the study and for ≥ 4 months after the last dose of study drug.

Exclusion Criteria:

* History of severe allergic reactions or hypersensitivity to BG-T187 or other monoclonal antibodies, or to the active ingredient and excipients of the study drug or camptothecins.
* For Phase 1a Part B Safety Expansion and Phase 1b only: Prior treatment with an EGFR-targeting ADC or mesenchymal-epithelial transition (MET)-targeting antibody-drug conjugate (ADC), or any ADC with topoisomerase I (TOPO1) inhibitor payload.
* Active leptomeningeal disease or uncontrolled, untreated brain metastasis. Participants with a history of treated and, at the time of screening, stable central nervous system (CNS) metastases are eligible, provided they meet all the following:

  1. Brain imaging at screening shows no evidence of interim progression, is clinically 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; off corticosteroids ≥ 14 days before dosing with study drug; anticonvulsants at a stable dose are allowed
  4. No stereotactic radiation or whole-brain radiation ≤ 14 days before the first dose 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/noninfectious pneumonitis, or where suspected active ILD/noninfectious pneumonitis cannot be ruled out by imaging during screening.
* Participants with active or chronic corneal disorder, including but not limited to Sjögren's, Fuch's corneal dystrophy, 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.

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

What this study is about

In the sponsor’s own words, from the registry.

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).

Study sites(15)

  • The University of Texas Md Anderson Cancer Center

    Houston, Texas, United States

    Recruiting

  • Next Oncology

    San Antonio, Texas, United States

    Recruiting

  • Next Oncology Virginia

    Fairfax, Virginia, United States

    Recruiting

  • Blacktown Cancer and Haematology Centre

    Blacktown, New South Wales, Australia

    Recruiting

  • Cancer Research South Australia

    Adelaide, South Australia, Australia

    Recruiting

  • Monash Health

    Clayton, Victoria, Australia

    Recruiting

  • The Alfred Hospital

    Melbourne, Victoria, Australia

    Recruiting

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, China

    Recruiting

  • Chongqing University Cancer Hospital

    Chongqing, Chongqing Municipality, China

    Recruiting

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian, China

    Recruiting

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, China

    Recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan, China

    Recruiting

  • Rui Jin Hospital Shanghai Jiao Tong University School of Medicinejiading Branch

    Shanghai, Shanghai Municipality, China

    Recruiting

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, China

    Recruiting

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, China

    Recruiting

Showing 15 of 15 sites. 15 of the 15 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07181681. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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A First-in-Human Study of BG-C0902 Alone and in Combination With Other Therapeutic Agents in Patients With Adv | Trialion