Posted: 4 July 2024
Amplia Therapeutics Limited (ASX: ATX), (“Amplia” or the “Company”), is pleased to announce that it has now recruited 26 patients in the Phase 2a stage of its clinical trial investigating narmafotinib in the treatment of advanced pancreatic cancer. The ACCENT trial explores the use of narmafotinib in combination with standard-of-care chemotherapy of gemcitabine and Abraxane® in first-line patients with advanced pancreatic cancer.
The Phase 1b stage of the trial, completed in November 2023, identified a 400 mg oral daily dose of narmafotinib, given in the days preceding regular chemotherapy infusion, as safe and well tolerated. This dosing regimen is being employed in the Phase 2a trial where drug efficacy is being assessed.
The Phase 2a trial is being conducted using the industry-standard Simon’s Two-Stage Trial design, wherein an interim analysis of efficacy is determined at a statistically defined number of patients. In the ACCENT trial this is 26 patients. An efficacy assessment showing six or more partial or complete responses out of the 26 patients will be sufficient to continue the trial, when an additional 24 patients will be enrolled, giving a total of 50 patients.
Amplia CEO and MD Dr Chris Burns commented: “The recruitment of our 26th patient is an important milestone for the Company. With 26 patients enrolled, and based on experience to date, we believe that the outcome from the interim analysis will be reported around the beginning of Q4 2024. Imaging data for the first patients from this cohort is now being collated and efficacy signals to date mirror the positive data previously reported from the Phase 1b stage of the trial.”
The ACCENT trial is currently being conducted at 6 sites in Australia and 5 sites in South Korea.
Dr Burns added: “We are grateful for the dedicated work of our study clinicians and clinical trial sites to reach this recruitment milestone, and as always thank the patients and their loved ones for being involved in the trial.”
