Actively Recruiting
T-Cell Therapy (ECT204) in Adults With Advanced HCC
Led by Eureka Therapeutics Inc. · Updated on 2025-12-05
20
Participants Needed
7
Research Sites
303 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 is suitable for adult subjects (≥ 18 years of age) diagnosed with GPC3-positive HCC, who have failed or not tolerated at least two (2) different anti-HCC systemic agents.
CONDITIONS
Official Title
T-Cell Therapy (ECT204) in Adults With Advanced HCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed unresectable, recurrent, or metastatic hepatocellular carcinoma (HCC)
- GPC3-positive tumor confirmed by immunohistochemistry (IHC): 10-20% tumor cells with 2+ IHC for dose escalation, 50% or more tumor cells with 2+/3+ IHC for expansion cohort
- Have failed or not tolerated at least two different anti-HCC systemic agents
- Life expectancy of at least 4 months according to investigator
- Karnofsky Performance Scale score of 70 or higher
- Measurable disease by RECIST v1.1 criteria
- Child-Pugh score of A6 or better
- Adequate organ function
You will not qualify if you...
- Pre-existing illnesses limiting study compliance, such as symptomatic congestive heart failure
- Active, uncontrolled systemic bacterial, fungal, or viral infections
- Active malignancy other than HCC, except cholangiocarcinoma or malignancies without organ involvement and expected survival of 3 years or more without treatment
- Pregnant or lactating women
- Receiving or ending liver tumor-directed therapy or hepatic surgery within 14 days before consent
- Concurrent participation in other investigational treatment studies
- Active autoimmune disease requiring systemic immunosuppressive therapy
- Presence of portal vein tumor thrombus grade Vp4 or invasion into the inferior vena cava
- Ascites requiring active treatment
- History of organ transplant
- Advanced HCC involving more than half of the liver
AI-Screening
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Trial Site Locations
Total: 7 locations
1
City of Hope
Duarte, California, United States, 91010
Actively Recruiting
2
Kansas University Medical Center, Principal Investigator:
Westwood, Kansas, United States, 66205
Completed
3
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States, 14263
Actively Recruiting
4
Oregon Health and Sciences University
Portland, Oregon, United States, 97239
Actively Recruiting
5
University of Texas Southwestern, Harold C. Simmons Comprehensive Cancer Center
Dallas, Texas, United States, 75235
Actively Recruiting
6
Fred Hutchinson Cancer Center, University of Washington
Seattle, Washington, United States, 98109
Actively Recruiting
7
National Taiwan University Cancer Center
Taipei, Taiwan, 106
Actively Recruiting
Research Team
T
Teresa Klask, MBA
CONTACT
P
Pei Wang, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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