T-Cell Therapy (ECT204) in Adults With Advanced HCC

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.