GPC3-Targeted T-Cell Therapy (ECT204) in Adults With Advanced HCC
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorEureka Therapeutics Inc.
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- ECT204 T cells
Treatment groups
60 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov