Recruiting
Phase 1

BG-C0902

Sponsor:

BeOne Medicines

Code:

NCT07181681

Conditions

Solid Tumors

Advanced Solid Tumor

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

BG-C0902

Study Details

Brief 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).

Conditions

Solid Tumors

Advanced Solid Tumor

Study ID

NCT07181681

Start date

Nov 10, 2025

Status verified date

Feb, 2026

Completion date

Nov 1, 2027

Anticipated

Primary completion date

Nov 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

63 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Phase 1a: Dose Escalation and Safety Expansion of BG-C0902

Sequential cohorts of increasing dose levels of BG-C0902 will be evaluated as monotherapy.

experimental: Phase 1b: Dose Expansion of BG-C0902

The recommended dose(s) for expansion (RDFE) for BG-C0902 from Part 1 will be evaluated in selected tumors.

Interventions

BG-C0902

Administered by intravenous infusion

Primary outcome measure

  • Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Approximately 24 Months ]
  • Phase 1a: Number of Participants with Dose Limiting Toxicities (DLTs) [ Time Frame: Approximately 21 Days ]
  • Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BG-C0902 [ Time Frame: Approximately 24 Months ]
  • Phase 1a: Recommended dose(s) for Expansion (RDFE) of BG-C0902 [ Time Frame: Approximately 24 Months ]
  • Phase 1b: Recommended Phase 2 Dose (RP2D) of BG-C0902 as Monotherapy [ Time Frame: Approximately 24 Months ]
  • Phase 1b: Overall Response Rate (ORR) [ Time Frame: Approximately 24 Months ]

Central Contacts and Locations

Central contacts

Locations

The University of Texas Md Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030-4009

Next Oncology

Recruiting

San Antonio, Texas, United States, 78229-6028

Next Virginia

Recruiting

Fairfax, Virginia, United States, 22031

More Information

Sponsor

BeOne Medicines

Last update posted

May 26, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by BeOne Medicines on 2026-05-26.