Melbourne-based biotech firm Amplia Therapeutics (ASX:ATX) announced a shift in its clinical programme, halting further recruitment for the AMPLICITY trial.
The study, which investigated the lead drug narmafotinib in combination with the chemotherapy regimen mFOLFIRINOX for advanced pancreatic cancer, was paused following three recorded instances of dose-limiting toxicities.
The company clarified that these toxicity concerns were attributed solely to the aggressive mFOLFIRINOX chemotherapy rather than narmafotinib itself.
Of the eight patients initially dosed, five remain on the study and will continue to receive the combination treatment under rigorous safety monitoring.
mFOLFIRINOX is a standard but notoriously "aggressive" treatment for fitter patients, and Amplia’s leadership noted an industry-wide trend towards seeking less toxic alternatives.
Despite the halt in recruitment, early efficacy signals from the AMPLICITY trial have shown promise.
Four of the eight participants recorded stable disease at their initial two-month scans, with one patient subsequently achieving a partial response at the four-month mark.
Dr Chris Burns, CEO and Managing Director of Amplia, expressed disappointment regarding the patient toxicities but remains optimistic about the company’s broader trajectory.
He emphasised that resources will now be reallocated towards the ongoing ACCENT study and the development of new, targeted agents.
The move reflects a pivot towards exploring narmafotinib in combination with more tolerable therapeutic frameworks.