Phase 2 Study of Becotatug Vedotin MRG003 Treatment in Adults With Advanced Hepatocellular Carcinoma Previously Treated with PD-1L1 Inhibitors

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 mgkg 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until the disease progresses, unacceptable side effects occur, the participant requests to stop, or consent is withdrawn.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.

Becotatug Vedotin (MRG003) in Previously Treated Advanced Hepatocellular Carcinoma