Becotatug Vedotin (MRG003) in Previously Treated Advanced Hepatocellular Carcinoma
China40 participantsStarted 2026-04-17
Plain-language summary
This study will evaluate the efficacy and safety of Becotatug vedotin, MRG003, in previously treated advanced hepatocellular carcinoma (HCC).
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Written informed consent obtained.
* Age ≥ 18 years at time of study entry.
* Locally advanced or metastatic and/or unresectable HCC with diagnosis confirmed by histology/ cytology or clinically by American Association for the Study of Liver Diseases (AASLD) criteria in cirrhotic patients.
* Disease progression after ≥1 line of PD-1/L1 inhibitors-based regimens.
* Archival or fresh biopsied tumor tissue samples obtained for immunohistochemistry (IHC) testing to determine EGFR protein.
* At least one measurable (per RECIST v1.1) target lesion that has not been previously treated with local therapy or, if the target lesion is within the field of previous local therapy, has subsequently progressed in accordance with RECIST v1.1.
* Child-Pugh scores 5-7, performance status (PS) ≤ 2 (ECOG scale).
* Subjects with chronic HBV infection must have HBV DNA viral load \< 100 IU/mL at screening. In addition, they must be on antiviral therapy per regional standard of care guidelines prior to initiation of study therapy.
* Life expectancy of at least 12 weeks.
* Adequate blood count, liver-enzymes, and renal function: absolute neutrophil count ≥ 1,500/L, platelets ≥60 x103/L; Total bilirubin ≤ 3x upper normal limit; Aspartate Aminotransferase (SGOT), Alanine aminotransferase (SGPT) ≤ 5 x upper normal limit (ULN); International normalized ratio (INR) ≤1.25; Albumin ≥ 31 g/dL; Serum Creatinine ≤ 1.5 x institutional ULN or creatinine clearance (CrCl) ≥ 30 mL/min (if usi…