Actively Recruiting
Becotatug Vedotin (MRG003) in Previously Treated Advanced Hepatocellular Carcinoma: A Single-arm, Multi-cohort, Phase 2 Trial
Led by Fudan University · Updated on 2026-04-21
40
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of Becotatug vedotin (MRG003) in adults with advanced hepatocellular carcinoma (HCC) who have previously undergone treatment. This phase 2 trial includes two groups based on the level of EGFR protein expression in tumors. The study aims to assess how well MRG003 works in these different patient groups and to monitor its safety outcomes over time. Participants in the study receive MRG003 as a single treatment given by intravenous infusion at a dose of 2.3 mg/kg on the first day of each 21-day cycle. Treatment continues until the disease progresses, unacceptable side effects occur, the participant requests to stop, or consent is withdrawn. The study enrolls two cohorts: one with high EGFR expression (3+) and another with low to moderate EGFR expression (0-2+), both receiving the same MRG003 monotherapy. During the trial, participants undergo regular assessments including tumor measurements based on standard criteria, blood tests to monitor liver and kidney function, and evaluations of side effects. The primary outcome is the objective response rate in the high EGFR expression group over up to 24 months. Secondary outcomes include response rates in the other group, disease control, duration and time to response, progression-free survival, overall survival, and treatment-related adverse events. Participants are followed for up to 42 months to gather comprehensive safety and effectiveness data.
CONDITIONS
Brief 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 time of study entry.
- Locally advanced, metastatic, or unresectable hepatocellular carcinoma confirmed by biopsy or clinical criteria.
- Disease progression after at least one line of PD-1 or PD-L1 inhibitor treatment.
- Tumor tissue sample available for EGFR protein testing.
- At least one measurable target lesion per RECIST v1.1, untreated or progressed after local therapy.
- Child-Pugh score between 5 and 7, ECOG performance status 0 to 2.
- For chronic hepatitis B patients: viral load below 100 IU/mL and on antiviral therapy.
- Life expectancy of at least 12 weeks.
- Adequate blood counts and liver and kidney function.
- Negative pregnancy test for females with reproductive potential within 7 days before trial start.
- Ability and willingness to comply with study protocol and contraceptive measures.
You will not qualify if you...
- Known fibrolamellar, sarcomatoid hepatocellular carcinoma, or mixed cholangiocarcinoma and HCC.
- Listed for liver transplantation or with advanced liver disease.
- Recent cardiac disease or significant gastrointestinal bleeding within 4 weeks before treatment.
- Thrombotic or embolic events within 6 months prior to treatment, except segmental portal vein thrombosis.
- Second primary cancer except treated basal skin cancer or cervical carcinoma in situ.
- Immunocompromised status or positive for HIV.
- Participation in another investigational study within 30 days or 7 half-lives of previous trial medication.
- Conditions interfering with treatment evaluation or safety including interstitial lung disease, coinfections, pancreatitis, active infections, organ transplant, immunodeficiency, recent steroid or immunosuppressive therapy, active autoimmune disease requiring systemic treatment.
- Live vaccine within 30 days before or during treatment.
- Central nervous system metastases unless treated and asymptomatic without steroids for 6 weeks.
- Medications interfering with study drugs.
- Use of other cancer treatments except study treatment at start.
- Pregnancy, breastfeeding, or inadequate contraception in patients of reproductive potential.
- History of non-compliance or inability to provide informed consent.
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 - Repeated 21-day cycles until disease progression or discontinuation
Participants receive MRG003 by IV infusion on day 1 of each 21-day cycle until disease progression, unacceptable toxicity, participant request, or withdrawal of consent.
1 visit every 21 days
Trial Site Locations
Total: 1 location
1
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
P
Peng Wang, MD
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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