Actively Recruiting
A First-in-Human Study of BG-C0902 Alone and in Combination With Other Therapeutic Agents in Patients With Advanced Solid Tumors
Led by BeOne Medicines · Updated on 2026-05-11
63
Participants Needed
13
Research Sites
103 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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 advanced, metastatic, or unresectable solid tumors not treatable with curative intent or lacking treatment options
- Ability to provide archival or fresh tumor tissue samples for analysis
- At least one measurable lesion assessed by RECIST v1.1
- 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 laboratory tests within 14 days before first dose
- Female participants of childbearing potential agree to use highly effective birth control during study and for at least 7 months after last dose, and have a negative pregnancy test within 3 days before first dose
- Nonsterile male participants agree to use highly effective birth control and avoid sperm donation during study and for at least 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 ADCs, MET-targeting ADCs, or any ADC with topoisomerase I inhibitor payload (Phase 1a Part B Safety Expansion and Phase 1b only)
- Active leptomeningeal disease or untreated, uncontrolled brain metastases
- Interstitial lung disease or Grade 2 or higher noninfectious pneumonitis within 2 years before first dose, or current active ILD/noninfectious pneumonitis
- Active or chronic corneal disorders that interfere with monitoring drug-induced eye effects
- Recent brain radiation within 14 days before first dose
- Requirement for corticosteroids for CNS disease within 14 days before first dose; stable anticonvulsant use allowed
- Other protocol-defined exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 13 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
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China, 400030
Actively Recruiting
9
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China, 361003
Actively Recruiting
10
Henan Cancer Hospital
Zhengzhou, Henan, China, 450000
Actively Recruiting
11
Rui Jin Hospital Shanghai Jiao Tong University School of Medicinejiading Branch
Shanghai, Shanghai Municipality, China, 201801
Actively Recruiting
12
West China Hospital, Sichuan University
Chengdu, Sichuan, China, 610041
Actively Recruiting
13
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022
Actively Recruiting
Research Team
S
Study Director
CONTACT
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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