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New treatment option for Hepatocellular Carcinoma
Official title GPC3-Targeted T-Cell Therapy (ECT204) in Adults With Advanced HCC
ClinicalTrials.gov ID: NCT04864054
What this study is testing
What is ECT204 T cells?
ECT204 T cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for hepatocellular carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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.
You likely can't join 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. people with Human Immunodeficiency Virus (HIV), hepatitis B, or hepatitis C are...
- History of malignancy other than HCC within 5 years before screening, except adequately treated basal cell or squamous cell skin cancer, in situ...
- Known brain metastases or other active central nervous system (CNS) involvement, including leptomeningeal disease. people with brain metastases that...
- 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...
See the full eligibility criteria
- 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.
- Pre-existing illness (e.g., symptomatic congestive heart failure) that would limit compliance with study requirements.
- Active, uncontrolled systemic bacterial, fungal, or viral infection. people with Human Immunodeficiency Virus (HIV), hepatitis B, or hepatitis C are eligible provided their infection is being treated and the viral load...
- 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. people with brain metastases that have been adequately treated (no evident neurological deficit and no...
- 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 people with IVC invasion who have been treated and radiographically stable for at...
- Ascites requiring active treatment, such as a requirement for paracentesis or escalation of diuretic doses. Exception: people 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...
- 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.
- Previously received other gene therapy (e.g., chimeric antigen receptor T-cell [CAR-T] therapy); exception: prior oncolytic virus therapy is permitted.).
- Contraindication for undergoing leukapheresis procedure or receipt of conditioning agents
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- Westwood, Kansas, United States
- Buffalo, New York, United States
- The Bronx, New York, United States
- Portland, Oregon, United States
- Dallas, Texas, United States
- Seattle, Washington, United States
- Taipei, Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; Westwood, Kansas, United States; Buffalo, New York, United States; The Bronx, New York, United States; Portland, Oregon, United States; Dallas, Texas, United States and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.