RecruitingHepatocellular CarcinomaLiver Cancer, AdultLiver Neoplasm
GPC3-Targeted T-Cell Therapy (ECT204) in Adults With Advanced HCC
Eligible age
18+ yrs
Accepts
All genders
Locations
6 states
Healthy volunteers
No
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About this study
This is an open-label, multi-center, Phase 1/2 clinical trial evaluating the safety, tolerability, and efficacy of ECT204, an investigational ARTEMIS® T-cell therapy, in adult subjects with GPC3-positive hepatocellular carcinoma (HCC) who have experienced disease progression on, or intolerance to, prior systemic therapy.
Sponsor: Eureka Therapeutics Inc.
You may qualify if…
- ✓ 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 received at least first-line systemic therapy for HCC and have experienced disease progression on, or intolerance to, that therapy.
- ✓ Life expectancy of at least 4 months per the Investigator's opinion.
- ✓ Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- ✓ Measurable disease by RECIST v1.1.
You may not qualify if…
- ✕ 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.
- ✕ History of malignancy other than HCC within 5 years before screening, except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other malignancies with low risk of recurrence.
- ✕ Known brain metastases or other active central nervous system (CNS) involvement, including leptomeningeal disease. Subjects with brain metastases that have been adequately treated (no evident neurological deficit and no steroid or anti-epileptic therapy for brain metastases) are eligible.
- ✕ 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.
Where it's recruiting
Source: ClinicalTrials.gov · NCT04864054 · last updated 2026-06-09