Phase 1/2 randomized, controlled, open-label trial of theranostic pair RYZ811 (diagnostic) and RYZ801 (therapeutic) to identify and treat subjects with GPC3+ unresectable hepatocellular carcinoma (HCC)
Age of at least 18 years at the time of signing the informed consent form (ICF)
Histologically/cytologically confirmed diagnosis of HCC.
Barcelona Clinic Liver Cancer (BCLC) Stage C or BCLC Stage B not amenable to locoregional therapy
Child-Pugh A
Subjects with fibrolamellar carcinoma, sarcomatoid HCC or combined hepatocellular cholangiocarcinoma
Prior liver transplantation
Known hypersensitivity to 68Ga, 225Ac or any of the excipients of RYZ811 or RYZ801
Portal vein tumor thrombosis classified as Vp4