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RecruitingLast updated: 15 April 2026

BG-C0902-101: Targeted treatment with BG-C0902 for people with advanced solid cancers that aren't responding to standard treatmentA 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

Trial purpose

Medical clipboardCancer treatment

Tumor type

Multi-Cancer Multi-Cancer

Age

People18+

Trial acronym

BG-C0902-101

Clinical summary

Summary

This is the first time the new treatment BG-C0902 is being tested in people. BG-C0902 is a type of targeted cancer therapy designed to attach to specific proteins found on some cancer cells (EGFR and MET) and deliver a cancer-killing medicine directly to them.

The purpose of this early phase study is to learn how safe the treatment is, what side effects it may cause, how the body processes the treatment, how the treatment affects cancer cells, and whether it shows any early signs of helping shrink or control tumours.

You may be eligible for this study if you have an advanced solid cancer that is no longer responding to standard treatments.

The study has two parts:

  • Phase 1a: Researchers will test different doses to find the safest amount and understand possible side effects.
  • Phase 1b: Once a safe dose is chosen, more patients will receive it to learn more about how well it works.

Conditions

This trial is treating people with advanced, metastatic or unresectable solid cancer

Eligibility

Inclusion

  • 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

  • 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.

Inclusion

  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • Your cancer has not spread to other parts of the body, but it is not possible to perform surgery to remove it (unresectable).
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

BeOne Medicines

Scientific Title

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

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