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Clinical Trials in the USA / NCT07181681
Recruiting Phase 1

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

NCT07181681 · tracked via the Priya Life Science USA tracker
Sponsor
BeOne Medicines
Phase
Phase 1
Started
2025-11-10
Last updated
2026-09-14

Condition(s) studied

Solid TumorsAdvanced Solid Tumor

Investigational drug(s) / intervention(s)

BG-C0902

BG-C0902: Administered by intravenous infusion

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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (14)

FacilityCityRegionStatus
The University of Texas Md Anderson Cancer Center Houston Texas Recruiting
Next Oncology San Antonio Texas Recruiting
Next Oncology Virginia Fairfax Virginia Recruiting
Blacktown Cancer and Haematology Centre Blacktown New South Wales Recruiting
Cancer Research South Australia Adelaide South Australia Recruiting
Monash Health Clayton Victoria Recruiting
The Alfred Hospital Melbourne Victoria Recruiting
Cancer Hospital Chinese Academy of Medical Sciences Beijing Beijing Municipality Recruiting
Chongqing University Cancer Hospital Chongqing Chongqing Municipality Recruiting
The First Affiliated Hospital of Xiamen University Xiamen Fujian Recruiting
Henan Cancer Hospital Zhengzhou Henan Recruiting
Rui Jin Hospital Shanghai Jiao Tong University School of Medicinejiading Branch Shanghai Shanghai Municipality Recruiting
West China Hospital, Sichuan University Chengdu Sichuan Recruiting
Zhejiang Cancer Hospital Hangzhou Zhejiang Recruiting

More BeOne Medicines trials in the USA

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07181681 on ClinicalTrials.gov ↗ ← All trials in the USA