GPC3-Targeted T-Cell Therapy (ECT204) in Adults With Advanced HCC

NCT04864054 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: ETUS20GPC3AR124
• Study Type: interventional
• Target: 60
• Locations: 2 countries
• Sites: 8

Brief Summary

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.

Conditions

Hepatocellular Carcinoma; Liver Cancer, Adult; Liver Neoplasm; Metastatic Liver Cancer

Keywords

Hepatocellular Carcinoma; Advanced HCC; Late-Stage HCC; Liver Cancer; Liver Neoplasm; Metastatic Liver Cancer; Metastatic HCC; T-cell therapy; Immunotherapy; HCC

Outcome Measures

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.

  Up to 2 years (active assessment period); additional long-term follow-up (LTFU) up to 15 years

Secondary Outcomes (11)

• To assess the efficacy of ECT204 using RECIST v1.1 | Overall Response Rate (ORR)

  Up to 15 years

• To assess the efficacy of ECT204 using RECIST v1.1 | Duration of Response (DOR)

  Up to 15 years

• To assess the efficacy of ECT204 using RECIST v1.1 | Progression-Free Survival (PFS)

  Up to 15 years

• To assess the efficacy of ECT204 using RECIST v1.1 | Disease Control Rate (DCR)

  Up to 15 years

• To assess the efficacy of ECT204 using RECIST v1.1 | Time to Response (TTR)

  Up to 15 years

Study Arms (1)

Dose Escalation, RP2D Confirmatory, and Expansion (Phase 1/2 Single Arm)

EXPERIMENTAL

Dose Escalation Cohort: Participants receive a single infusion of ECT204 at one of four predefined dose levels on Day 0 (completed). RP2D Confirmatory Cohort: Participants receive ECT204 at the RP2D on Day 0 and may receive a second infusion approximately one month later. Expansion Cohort: Participants receive multiple infusions of ECT204 at the RP2D, beginning on Day 0, with subsequent infusions administered according to the protocol-defined schedule.

Biological: ECT204 T cells

Interventions

ECT204 T cells BIOLOGICAL

ECT204 is an autologous T-cell therapy whereby a subject's own T cells are transduced with a lentiviral vector expressing the ECT204 transgene.

Dose Escalation, RP2D Confirmatory, and Expansion (Phase 1/2 Single Arm)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 received at least first-line systemic therapy for HCC and have experienced disease progression on, or intolerance to, that therapy.
• Life expectancy of at least 4 months per the Investigator's opinion.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
• Measurable disease by RECIST v1.1.
• Child-Pugh score of A6 or better.
• Adequate organ function.

You may not qualify if:

• 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.
• 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), except for subjects with IVC invasion who have been treated and radiographically stable for at least 6 months prior to screening.
• Ascites requiring active treatment, such as a requirement for paracentesis or escalation of diuretic doses. Exception: Subjects maintained on a stable dose of diuretics with controlled, asymptomatic ascites are eligible.
• Active gastrointestinal (GI) bleeding event ≥ Grade 3 per National Cancer Institute (NCI) Common Terminology for Adverse Events (CTCAE), version 5.0, within 6 months prior to screening.
• Coagulation abnormality defined as international normalized ratio (INR) \> 1.7, unless the elevation is due to therapeutic anticoagulation that, in the Investigator's judgment, can be safely managed in the context of study procedures.
• History of organ transplant.
• HCC involving greater than 50% of the liver volume.
• Experienced allergies to any component of the study drug (ECT204), mouse immunoglobulin, or iron-dextran, or have a history of severe hypersensitivity, including anaphylaxis.

Sponsors & Collaborators

• Eureka Therapeutics Inc.: lead

Study Sites (8)

City of Hope

Duarte, California, 91010, United States

RECRUITING

Kansas University Medical Center, Principal Investigator:

Westwood, Kansas, 66205, United States

COMPLETED

Roswell Park Comprehensive Cancer Center

Buffalo, New York, 14263, United States

COMPLETED

Montefiore Einstein Comprehensive Cancer Center

The Bronx, New York, 10467, United States

RECRUITING

Oregon Health and Sciences University

Portland, Oregon, 97239, United States

RECRUITING

University of Texas Southwestern, Harold C. Simmons Comprehensive Cancer Center

Dallas, Texas, 75235, United States

RECRUITING

Fred Hutchinson Cancer Center, University of Washington

Seattle, Washington, 98109, United States

RECRUITING

National Taiwan University Cancer Center

Taipei, 106, Taiwan

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Pei Wang, PhD

  Eureka Therapeutics Inc.

  STUDY DIRECTOR

Central Study Contacts

Teresa Klask, MBA

CONTACT

925-949-9314; Teresa.Klask@eurekainc.com

Pei Wang, PhD

CONTACT

510-654-7045; Pei.Wang@eurekainc.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2021
• First Posted: April 28, 2021
• Study Start: March 11, 2022
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 9, 2026

Record last verified: 2026-06

Locations

US (7); TW (1)