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

Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorLepu Biopharma Co., Ltd.

About this trial

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).

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Acute or chronic active hepatitis B or hepatitis C infection.

Trial design

Treatments tested in this trial

  • MRG006A
  • MRG006A
  • MRG006A

Treatment groups

160 Participants
are divided into 3 treatment groups

Sponsors and collaborators