Eureka Therapeutics has started enrolling adults with advanced hepatocellular carcinoma (HCC), the most common form of liver cancer, in a Phase 1/2 trial of its investigational ET140203 T-cell therapy.
The trial, called ARYA-1 (NCT04502082), seeks to enroll around 50 patients whose tumors contain alpha-fetoprotein (AFP), a protein that is overly produced by some types of malignant cells, including liver cancer cells.
Participants are being recruited at the City of Hope Medical Center and the University of California Davis. Two other sites — one in California and another in Kansas — are not yet recruiting patients. More information about trial contacts and recruiting sites can be found here.
The study will be divided into two phases. The first phase will assess the safety and tolerability of increasing doses of ET140203 to determine the best dose to be used in the next phase of the study. The incidence and severity of adverse events, as well as the incidence of any dosage-related toxicities will be evaluated over the course of 28 days.
During the second phase of the trial, which will last up to two years, investigators will assess the therapy’s efficacy and pharmacokinetic properties. Pharmacokinetics studies how the body absorbs, processes, and eliminates a compound.
“We are very excited to initiate our ET140203 ARYA-1 clinical trial,” Cheng Liu, PhD, president and CEO of Eureka Therapeutics, said in a press release.
“We believe that poor infiltration of T-cells into solid tumors is a significant barrier to developing T-cell therapies with curative potential,” he said. “ET140203 can potentially address this limitation associated with the current generation of CAR and TCR therapies, and we are pleased to be able to bring this therapy into the clinic.”
ET140203 contains patient-derived immune T-cells that have been genetically modified to target and destroy cancer cells containing AFP protein complexes.
Like its predecessor, ET140202, which was authorized to enter clinical testing last year in the U.S., ET140203 uses the company’s proprietary Artemis cell receptor platform that is designed to take advantage of T-cells’ natural mechanisms to fight against cancer.
According to Eureka, this technology also enables ET140203 modified T-cells to infiltrate into solid tumors. In animal models, these genetically-modified T-cells have been shown to safely and effectively infiltrate these types of tumors, suggesting their potential efficacy in patients.