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)

Who is this study for? Adult patients with liver cancer
What treatments are being studied? ECT204 T cells
Status: Recruiting
Location: See all (7) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
California
City of Hope
RECRUITING
Duarte
Kansas
Kansas University Medical Center, Principal Investigator:
COMPLETED
Westwood
New York
Roswell Park Comprehensive Cancer Center
RECRUITING
Buffalo
Oregon
Oregon Health and Sciences University
RECRUITING
Portland
Texas
University of Texas Southwestern, Harold C. Simmons Comprehensive Cancer Center
RECRUITING
Dallas
Washington
Fred Hutchinson Cancer Center, University of Washington
RECRUITING
Seattle
Other Locations
Taiwan
National Taiwan University Cancer Center
RECRUITING
Taipei
Contact Information
Primary
Teresa Klask, MBA
Teresa.Klask@eurekainc.com
925-949-9314
Backup
Pei Wang, PhD
Pei.Wang@eurekainc.com
510-654-7045
Time Frame
Start Date: 2022-03-11
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 20
Treatments
Experimental: Dose Escalation, RP2D Confirmatory, and Expansion (Phase 1/2 Single Arm)
Dose Escalation Cohort: Patients receive a single infusion of ECT204 T cells at one of four predefined dose levels on Day 0 after conditioning. Conditioning consists of fludarabine (Flu) and cyclophosphamide (Cy).~RP2D Confirmatory Cohort: Patients receive ECT204 T cells at the RP2D on Day 0 and may receive a second infusion approximately one month later. This cohort uses the same Flu/Cy conditioning as the dose-escalation cohort; no conditioning is given before the second ECT204 infusion.~Expansion Cohort: Patients receive multiple ECT204 infusions at the RP2D (initial on Day 0, planned second on Day 31, and optional third or later doses). The third infusion may be administered no earlier than Day 60, and each subsequent infusion must be separated by at least 30 days. Patients receive Flu/Cy/regorafenib before the first infusion and regorafenib alone before the second and subsequent infusions.
Authors
Raed Al-Rajabi
Related Therapeutic Areas
Sponsors
Leads: Eureka Therapeutics Inc.

This content was sourced from clinicaltrials.gov