Clinical Research Directory

Inclusion Criteria: * Histologically confirmed HCC, that is unresectable, recurrent, and/or metastatic. * GPC3-positive tumor expression confirmed by immunohistochemistry (IHC). * For the dose-escalation cohort: ≥10-20% tumor cells, ≥2+ IHC. * Beginning with the RP2D confirmatory cohort: ≥ 50% tumor cells, 2+/3+ IHC. * Must have failed, or not tolerated, at least two (2) different anti-HCC systemic agents. * Life expectancy of at least 4 months per the Investigator's opinion. * Karnofsky Performance Scale of 70 or higher. * Measurable disease by RECIST v1.1. * Child-Pugh score of A6 or better. * Adequate organ function. Exclusion Criteria: * Pre-existing illness (e.g., symptomatic congestive heart failure) that would limit compliance with study requirements. * Active, uncontrolled systemic bacterial, fungal, or viral infection. Subjects with Human Immunodeficiency Virus (HIV), hepatitis B, or hepatitis C are eligible provided their infection is being treated and the viral load is controlled. * Active malignancy (other than HCC), with the exception of cholangiocarcinoma (CCA) or any malignancy without any organ involvement and with an expected survival ≥ 3 years without any treatment (exception: hormone/androgen- deprivation therapy). * Pregnant or lactating women. * Currently receiving or ending (\< 14 days from date of consent) liver tumor-directed therapy (e.g., radiation, ablation, embolization), or hepatic surgery. * Concurrently receiving other investigational agents, biological, chemical, or radiation therapies, while participating in the study. * Active autoimmune disease requiring systemic immunosuppressive therapy. * Presence of portal vein tumor thrombus (PVTT) classified as grade Vp4, or any invasion into the inferior vena cava (IVC). * Ascites requiring active treatment. * History of organ transplant. * Advanced HCC involving greater than half (50%) of the liver.