Amplia has announced 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 Phase 1b stage of the trial, completed in November 2023, identified a safe and tolerated 400 mg oral daily dose of narmafotinib, which is being employed in the Phase 2a trial where drug efficacy is being assessed.
The Phase 2a trial uses an industry-standard Simon’s Two-Stage Trial design. An interim analysis will be conducted with responses from the 26 patients to assess efficacy. If the efficacy assessment shows six or more partial or complete responses, the trial will continue to enrol an additional 24 patients, totalling 50.
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.”
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