Status:
RECRUITING
T-Cell Therapy (ECT204) in Adults With Advanced HCC
Lead Sponsor:
Eureka Therapeutics Inc.
Conditions:
Hepatocellular Carcinoma
Liver Cancer, Adult
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This is an open-label, dose escalation, multi-center, Phase I/II clinical trial aimed at assessing the safety and preliminary efficacy of an investigational ARTEMIS® ECT204 T-cell therapy. The trial i...
Detailed Description
This is an open-label, dose-escalation, multi-center, Phase I/II clinical trial. The purpose of this study is to evaluate an investigational ECT204 T-cell therapy in adult patients with GPC3-positive ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04864054
Start Date
March 11 2022
End Date
December 31 2027
Last Update
December 5 2025
Active Locations (7)
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1
City of Hope
Duarte, California, United States, 91010
2
Kansas University Medical Center, Principal Investigator:
Westwood, Kansas, United States, 66205
3
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States, 14263
4
Oregon Health and Sciences University
Portland, Oregon, United States, 97239