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Study of BG-C0902 for Advanced Solid Tumors

This study is testing a new treatment called BG-C0902 for people with advanced solid tumors. BG-C0902 is an antibody-drug conjugate (ADC) that targets specific proteins (EGFR and MET) found on cancer cells. The main goals of this study are to see how safe BG-C0902 is, what side effects it might cause, and how well it works against cancer. You might be able to join if you have advanced, metastatic, or unresectable solid tumors that haven't responded to other treatments or for which no other treatments are available. The study will also look at biomarkers like EGFR and MET. This is a "first-in-human" study, meaning it's the first time this drug is being tested in people.

Study design
This is a Phase 1a/1b interventional study, which means it's an early-stage trial to find the right dose and check for safety. It plans to enroll 63 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety will be measured for approximately 24 months, and dose-limiting toxicities will be assessed for approximately 21 days.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07181681

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
BeOne Medicines
~63 participants
Updated 2026-09-14 on ClinicalTrials.gov
What's tested:BG-C0902

At a glance

Recruiting sites
14 of 14 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured over Approximately 24 Months
+5 more outcomes measured

Conditions

Solid Tumors
Advanced Solid Tumor

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NCT07181681

Where you'd take part

This study runs at 14 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Blacktown Cancer and Haematology Centre

    Blacktown, New South Wales, Australiano site contact published

    Recruiting

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, Chinano site contact published

    Recruiting

  • Cancer Research South Australia

    Adelaide, South Australia, Australiano site contact published

    Recruiting

  • Chongqing University Cancer Hospital

    Chongqing, Chongqing Municipality, Chinano site contact published

    Recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan, Chinano site contact published

    Recruiting

  • Monash Health

    Clayton, Victoria, Australiano site contact published

    Recruiting

  • Next Oncology

    San Antonio, Texasno site contact published

    Recruiting

  • Next Oncology Virginia

    Fairfax, Virginiano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Study Director · STUDY_DIRECTOR · BeOne Medicines

Who to contact

Study Director
[email protected]
1.877.828.5568
Email the study team

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Eligibility criteria

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:
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.

What this trial measures

  • Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)Approximately 24 Months
  • Phase 1a: Number of Participants with Dose Limiting Toxicities (DLTs)Approximately 21 Days
  • Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BG-C0902Approximately 24 Months

    MTD is defined as the highest dose evaluated for which estimated toxicity rate is the closest to the target toxicity rate. MAD is defined as the highest dose administered if MTD is not reached.

  • Phase 1a: Recommended dose(s) for Expansion (RDFE) of BG-C0902Approximately 24 Months

    RDFE of BG-C0902 will be determined based upon the MTD or MAD.

  • Phase 1b: Recommended Phase 2 Dose (RP2D) of BG-C0902 as MonotherapyApproximately 24 Months

    RP2D as determined based on safety, pharmacokinetics (PK), pharmacodynamics, preliminary antitumor activity, and other relevant data, as available.

  • Phase 1b: Overall Response Rate (ORR)Approximately 24 Months

    ORR is defined as the percentage of participants with best overall response of complete response (CR) or partial response (PR) as determined from tumor assessments by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.