MRG006A Combination Therapy for Advanced Hepatocellular Carcinoma (Phase I/II)
China160 participantsStarted 2026-04
Plain-language summary
This is an open-label, multicenter, Phase I/II clinical study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of MRG006A in combination with immune checkpoint inhibitors and targeted therapy in patients with advanced hepatocellular carcinoma (HCC).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Able to understand and provide written informed consent, and comply with the requirements specified in the protocol.
✓. Life expectancy ≥ 3 months.
✓. Must provide tumor tissue specimens for GPC3 testing.
✓. Histologically/cytologically confirmed hepatocellular carcinoma (HCC), Barcelona Clinic Liver Cancer (BCLC) Stage C or Stage B not amenable to curative surgery and/or locoregional therapy.
✓. At least one measurable lesion per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) and modified RECIST (mRECIST).
✓. No prior systemic antineoplastic therapy for unresectable HCC before first dose administration.
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, with no deterioration within 2 weeks prior to first study drug administration.
✓. Adequate organ function as specified.
Exclusion criteria
✕. Prior histologically/cytologically confirmed diagnosis of hepatocellular carcinoma with fibrolamellar, sarcomatoid, cholangiocarcinoma, or other components.
✕. History of hepatic failure or hepatic encephalopathy, or history of liver transplantation.
✕. Pleural effusion, ascites, or pelvic effusion, or clinically significant pericardial effusion.