Amplia Therapeutics has recruited the first 26 subjects in the Phase IIa portion of its ACCENT clinical trial of narmafotinib to treat advanced pancreatic cancer.
The Phase IIa stage was launched following the conclusion of the Phase Ib trial in November last year.
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The Phase Ib trial established a safe and tolerable daily oral dose of 400mg for narmafotinib.
The Phase IIa trial, assessing this dosage level, employs Simon’s Two-Stage Trial design. To evaluate the efficacy, an interim analysis will be carried out once responses from the 26 patients have been gathered.
Should this analysis reveal six or more partial or complete responses, the trial will enrol an additional 24 patients, aiming for a total of 50 participants.
Amplia CEO and MD Dr Chris Burns said: “The recruitment of our 26th patient is an important milestone for the company.
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By GlobalData“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.”
Amplia received clearance for an investigational new drug (IND) application from the US Food and Drug Administration in January.
The IND clearance enabled the commencement of a clinical trial to explore the combination of narmafotinib with the chemotherapy regimen FOLFIRINOX, which is widely used in the US and Europe for treating pancreatic cancer.
The proposed trial will assess the safety, tolerability and efficacy of narmafotinib plus FOLFIRINOX.
Parallel to this trial, Amplia is also conducting a study in Australia and South Korea assessing narmafotinib plus gemcitabine and Abraxane in advanced pancreatic patients.
