Actively Recruiting
A Phase 1a/b Study to Investigate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BG-C0902, an Antibody-Drug Conjugate Targeting EGFR x MET, Alone and With Other Agents in Advanced Solid Tumors
Led by BeOne Medicines · Updated on 2026-05-26
63
Participants Needed
14
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating BG-C0902, a new antibody-drug conjugate targeting the epidermal growth factor receptor (EGFR) and mesenchymal-epithelial transition (MET) in people with advanced solid tumors. This first-in-human Phase 1a/1b study aims to assess the safety, tolerability, how the drug behaves in the body (pharmacokinetics and pharmacodynamics), and early signs of its ability to fight tumors. The study is sponsored by BeOne Medicines and includes two phases: dose escalation and safety expansion (Phase 1a) and dose expansion (Phase 1b). Participants will receive BG-C0902 through intravenous infusion in doses that increase over time during Phase 1a to find the recommended dose for further study. In Phase 1b, this recommended dose will be tested in selected tumor types. The study does not use randomization or blinding and involves sequential patient groups receiving the drug alone or in combination with other treatments. During the study, participants will undergo evaluations for adverse events, dose limiting toxicities, and tumor responses over approximately two years. Researchers will monitor blood levels of the drug and related antibodies, assess tumor changes using standard criteria, and check overall health status. Safety and effectiveness measurements will be collected regularly, with follow-up to understand how well participants respond and tolerate the treatment over time.
CONDITIONS
Brief Title
A First-in-Human Study of BG-C0902 Alone and in Combination With Other Therapeutic Agents in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants with confirmed advanced, metastatic, or unresectable solid tumors not suitable for curative treatment
- Ability to provide tumor tissue samples such as archival or fresh biopsy samples
- At least one measurable lesion according to RECIST v1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 within 14 days before first dose
- Adequate bone marrow and organ function based on lab tests within 14 days before first dose
- Female participants of childbearing potential must use effective birth control during the study and for 7 months after last dose, and have negative pregnancy test within 3 days before first dose
- Male participants who are not sterile must use effective birth control and avoid sperm donation during the study and for 4 months after last dose
You will not qualify if you...
- History of severe allergic reactions or hypersensitivity to BG-T187, monoclonal antibodies, study drug ingredients, or camptothecins
- Prior treatment with EGFR-targeting ADC, MET-targeting ADC, or any ADC with TOPO1 inhibitor payload for Phase 1a Part B Safety Expansion and Phase 1b
- Active leptomeningeal disease or uncontrolled untreated brain metastases; stable CNS metastases allowed under specific conditions
- History of interstitial lung disease or significant noninfectious pneumonitis within 2 years or current active disease
- Active or chronic corneal disorders that interfere with monitoring drug-induced keratopathy
- Other protocol-defined inclusion or exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 24 months
Participants receive BG-C0902 by intravenous infusion as part of sequential cohorts with increasing doses or at recommended doses for expansion in selected tumors.
Visits occur regularly during treatment for dosing and monitoring
Trial Site Locations
Total: 14 locations
1
The University of Texas Md Anderson Cancer Center
Houston, Texas, United States, 77030-4009
Actively Recruiting
2
Next Oncology
San Antonio, Texas, United States, 78229-6028
Actively Recruiting
3
Next Virginia
Fairfax, Virginia, United States, 22031
Actively Recruiting
4
Blacktown Cancer and Haematology Centre
Blacktown, New South Wales, Australia, NSW 2148
Actively Recruiting
5
Cancer Research South Australia
Adelaide, South Australia, Australia, SA 5000
Actively Recruiting
6
Monash Health
Clayton, Victoria, Australia, VIC 3168
Actively Recruiting
7
The Alfred Hospital
Melbourne, Victoria, Australia, VIC 3004
Actively Recruiting
8
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
Actively Recruiting
9
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China, 400030
Actively Recruiting
10
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China, 361003
Actively Recruiting
11
Henan Cancer Hospital
Zhengzhou, Henan, China, 450000
Actively Recruiting
12
Rui Jin Hospital Shanghai Jiao Tong University School of Medicinejiading Branch
Shanghai, Shanghai Municipality, China, 201801
Actively Recruiting
13
West China Hospital, Sichuan University
Chengdu, Sichuan, China, 610041
Actively Recruiting
14
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022
Actively Recruiting
Research Team
S
Study Director
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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