RECRUITING

T-Cell Therapy (ECT204) in Adults With Advanced HCC

Description

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. The study includes a dose escalation phase (Part 1 or Phase I) to determine the Recommended Phase II Dose (RP2D), followed by an expansion phase (Part 2 or Phase II) to further assess safety and efficacy.

Conditions

Hepatocellular CarcinomaLiver Cancer, AdultLiver NeoplasmMetastatic Liver Cancer
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Related Conditions:

Hepatocellular CarcinomaLiver Cancer, AdultLiver NeoplasmMetastatic Liver Cancer

Study Overview

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Study Details

Study overview

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. The study includes a dose escalation phase (Part 1 or Phase I) to determine the Recommended Phase II Dose (RP2D), followed by an expansion phase (Part 2 or Phase II) to further assess safety and efficacy.

An Open-Label, Dose Escalation, Multi-Center Phase I/II Clinical Trial of ECT204 T-Cell Therapy in Adults With Advanced Hepatocellular Carcinoma (HCC) (ARYA-3)

T-Cell Therapy (ECT204) in Adults With Advanced HCC

Condition
Hepatocellular Carcinoma
Intervention / Treatment

-

Contacts and Locations

Duarte

City of Hope, Duarte, California, United States, 91010

Westwood

Kansas University Medical Center, Principal Investigator:, Westwood, Kansas, United States, 66205

Buffalo

Roswell Park Comprehensive Cancer Center, Buffalo, New York, United States, 14263

Seattle

Fred Hutchinson Cancer Center, University of Washington, Seattle, Washington, United States, 98109

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Histologically confirmed HCC, which is unresectable, recurrent and/or metastatic.
  • * GPC3-positive expression in HCC tumor cells confirmed by immunohistochemistry (IHC).
  • * For Phase 1 (dose escalation): ≥10-20% tumor cells, ≥2+ IHC).
  • * For Phase 2 (expansion): ≥ 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. Previously treated lesions are allowed as long as there is a new confirmed measurable component.
  • * Child-Pugh score of A6 or better.
  • * Adequate organ function.
  • * 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).
  • * 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 therapy.
  • * Compromised circulation in the main portal vein, hepatic vein, or vena cava due to obstruction.
  • * History of organ transplant.
  • * Advanced HCC involving greater than half (50%) of the liver.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Eureka Therapeutics Inc.,

Pei Wang, PhD, STUDY_DIRECTOR, Eureka Therapeutics Inc.

Study Record Dates

2027-12-31