Actively Recruiting
Becotatug Vedotin (MRG003) in Previously Treated Advanced Hepatocellular Carcinoma
Led by Fudan University · Updated on 2026-04-21
40
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study will evaluate the efficacy and safety of Becotatug vedotin, MRG003, in previously treated advanced hepatocellular carcinoma (HCC).
CONDITIONS
Official Title
Becotatug Vedotin (MRG003) in Previously Treated Advanced Hepatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent obtained.
- Age 18 years or older at study entry.
- Locally advanced, metastatic, or unresectable hepatocellular carcinoma confirmed by histology, cytology, or clinical criteria.
- Disease progression after at least one line of PD-1 or PD-L1 inhibitor therapy.
- Tumor tissue available for EGFR protein testing.
- At least one measurable target lesion per RECIST v1.1 criteria.
- Child-Pugh score between 5 and 7 and ECOG performance status 0 to 2.
- For chronic hepatitis B patients, HBV DNA viral load less than 100 IU/mL and on antiviral therapy.
- Life expectancy of at least 12 weeks.
- Adequate blood counts and organ function within specified limits.
- Negative pregnancy test for females with reproductive potential within 7 days before trial start.
- Willingness and ability to comply with study protocol and contraceptive measures.
You will not qualify if you...
- Known fibrolamellar, sarcomatoid hepatocellular carcinoma, or mixed cholangiocarcinoma and hepatocellular carcinoma.
- Patients listed for liver transplantation or with advanced liver disease.
- History of cardiac disease or significant gastrointestinal bleeding within 4 weeks before treatment.
- Thrombotic or embolic events within 6 months prior to study drug, except segmental portal vein thrombosis.
- Second primary cancer except treated basal skin cancer or carcinoma in-situ of the cervix.
- Immunocompromised status including known HIV infection.
- Participation in another investigational study within 30 days or 7 half-lives of prior medication.
- Conditions interfering with treatment evaluation or safety, including interstitial lung disease, HBV and HCV coinfection, acute or chronic pancreatitis, active infections, organ transplant history, immunodeficiency, recent systemic steroid or immunosuppressive therapy, active autoimmune disease requiring treatment.
- Live vaccine within 30 days prior to treatment or during study.
- History or clinical evidence of CNS metastases unless asymptomatic and off steroids for 6 weeks.
- Use of medications interfering with study agents.
- Use of other cancer treatments except study treatment at study start.
- Receipt of investigational products within 28 days before study entry.
- Pregnancy, breastfeeding, or reproductive potential without effective contraception.
- History of non-compliance or inability to give informed consent.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
P
Peng Wang, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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