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

Launched by EUREKA THERAPEUTICS INC. · Apr 26, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called ARTEMIS® ECT204 T-cell therapy for adults with advanced liver cancer, specifically a type called hepatocellular carcinoma (HCC). The aim is to find out how safe this therapy is and whether it can help patients whose cancer has not responded to at least two previous treatments. To participate, you need to be an adult aged 18 or older, have a specific type of liver cancer that cannot be surgically removed, and your tumor must show a certain protein called GPC3. You also need to have a life expectancy of at least four months and meet other health criteria.

If you are eligible and decide to join the trial, you will receive the ECT204 treatment and be closely monitored for any side effects and how well the therapy is working. The trial is still recruiting participants, which means that new patients can still enroll. This is an important opportunity to help researchers learn more about this potential new treatment option for advanced liver cancer, while also possibly gaining access to a therapy that might help improve your condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Histologically confirmed HCC, which is unresectable, recurrent and/or metastatic.
• • GPC3-positive expression in HCC tumor cells confirmed by immunohistochemistry (IHC). To be eligible for Phase 2 (expansion phase) of the study, the subject's tumor biopsy sample (resection or needle core sample) must demonstrate that more than 50% of tumor cells exhibit at least 3+ GPC3 expression intensity.
• • 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.
• 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.
• • 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.