MRG006A Combination Therapy for Advanced Hepatocellular Carcinoma (Phase I/II)

Prior treatment

• Prior histologically/cytologically confirmed diagnosis of hepatocellular carcinoma with fibrolamellar, sarcomatoid, cholangiocarcinoma, or other components.
• Prior locoregional therapy for hepatocellular carcinoma within 4 weeks before first dose administration.
• Receipt of live attenuated vaccines within 4 weeks before first dose or planned administration during the study period.
• Major surgical procedure within 4 weeks before first dose, or the presence of unhealed wounds, ulcers, or bone fractures.
• Toxicities from prior therapy that have not resolved to Grade 0 or 1 before first dose of study treatment.
• Severe cardiac insufficiency or cerebrovascular events within 6 months prior, or occurrence of pulmonary embolism, deep vein thrombosis, gastrointestinal perforation and/or fistula, or intestinal obstruction.
• Hypersensitivity to any component or excipient of the investigational product.

Other illness

• History of hepatic failure or hepatic encephalopathy, or history of liver transplantation.
• Acute or chronic active hepatitis B or hepatitis C infection.
• Uncontrolled or poorly controlled medical conditions.
• Patients with double or multiple primary malignancies.
• Active or poorly controlled severe infection.
• Any severe and/or uncontrolled systemic disease that, in the opinion of the investigator and sponsor, renders the patient unsuitable for participation in this study.

Other

• Pleural effusion, ascites, or pelvic effusion, or clinically significant pericardial effusion.
• Central nervous system metastases.

• 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.
• Negative serum pregnancy test within 7 days prior to first dose (women of childbearing potential). Pregnant or lactating women are not eligible for this study.
• Women of childbearing potential and male patients must agree to use adequate contraception during MRG006A treatment and for 180 days after the last infusion.