Is NCT04864054 recruiting in Dallas, TX?

Yes, NCT04864054 is currently recruiting participants at its Dallas, TX location. This liver cancer clinical trial is actively enrolling qualified participants.

How do I join the liver cancer clinical trial in Dallas?

To join this clinical trial in Dallas, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Dallas clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Liver Cancer Clinical Trial in Dallas, TX

About This Liver Cancer Study in Dallas

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

Sponsor: Eureka Therapeutics Inc.

Who Can Participate

Inclusion 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.

Exclusion Criteria

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.

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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Dallas?

Yes, this clinical trial (NCT04864054) has an active research site in Dallas, TX that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Liver Cancer Treatment Options in Dallas, TX

If you're searching for liver cancer treatment options in Dallas, TX, this clinical trial (NCT04864054) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Dallas research site is actively enrolling participants for this phase 1/2 clinical trial. You'll receive care from experienced liver cancer specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all liver cancer clinical trials near you to find additional studies recruiting in your area.

Liver Cancer Clinical Trial in Dallas, TX

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