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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
ECT204 T cells
Biological/VaccineECT204 is an autologous T-cell therapy whereby a subject's own T cells are transduced with a lentiviral vector expressing the ECT204 transgene.
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Dose Escalation, RP2D Confirmatory, and Expansion (Phase 1/2 Single Arm)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
To assess the safety and tolerability of ECT204.
Type, frequency, and severity of adverse events (AEs), including treatment-emergent AEs (TEAEs), treatment-related AEs (TRAEs), serious adverse events (SAEs), adverse events of special interest (AESIs), clinically significant laboratory abnormalities recorded as AEs, and AEs leading to permanent discontinuation.
Time frame
Up to 2 years (active assessment period); additional long-term follow-up (LTFU) up to 15 yearsSecondary outcomes
1
To assess the efficacy of ECT204 using RECIST v1.1 | Overall Response Rate (ORR)
ORR, defined as the proportion of subjects with a best overall response (BOR) of either CR or PR.
Time frame
Up to 15 years2
To assess the efficacy of ECT204 using RECIST v1.1 | Duration of Response (DOR)
DOR, defined as the time from first documented occurrence of CR or PR to PD or death from any cause, whichever occurs first.
Time frame
Up to 15 years3
To assess the efficacy of ECT204 using RECIST v1.1 | Progression-Free Survival (PFS)
PFS, defined as the time from first ECT204 infusion to PD or death from any cause, whichever occurs first.
Time frame
Up to 15 years4
To assess the efficacy of ECT204 using RECIST v1.1 | Disease Control Rate (DCR)
DCR, defined as the proportion of subjects with BOR of CR, PR, or SD.
Time frame
Up to 15 yearsSponsors and contacts
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Source ClinicalTrials.gov