French company ERYTECH Pharma has opened the Phase III TRYbeCA1 clinical trial of eryaspase for the enrolment of patients with second-line metastatic pancreatic cancer in the US.
Eryaspase is made of L-asparaginase placed inside donor-derived red blood cells. The drug candidate is designed to target the modified asparagine and glutamine metabolism of cancer cells.
The randomised, controlled TRYbeCA1 trial will compare the drug and standard chemotherapy combination with chemotherapy alone in around 500 patients at nearly 100 sites in the US and Europe.
Simultaneous to opening the US enrolment, the company has activated the first of an intended 30 sites in the country.
During the trial, gemcitabine/nab-paclitaxel or an irinotecan-based regimen will be used as chemotherapy. The primary endpoint is overall survival.
An interim superiority analysis is expected to be carried out in the third quarter of next year.
Erytech added that the study’s Independent Data Monitoring Committee (IDMC ) analysed safety data from the initial 150 enrolled and treated participants. The committee did not find any safety issues and said that the trial could continue as planned.
Erytech Pharma chief medical officer Dr Iman El-Hariry said: “The positive safety review by the IDMC of the first 150 patients in the study confirms the favourable safety profile of the eryaspase product candidate, which is key because in this trial, eryaspase is combined with chemotherapy regimens that carry significant inherent toxicity.”
The company will manufacture eryaspase for the treatment of US patients at its new manufacturing facility in Princeton, New Jersey.
Besides second-line pancreatic cancer, the drug candidate is in Phase II development for treating triple-negative breast cancer and acute lymphoblastic leukaemia.