Amplia Therapeutics (ASX:ATX) has halted recruitment to its AMPLICITY clinical trial.
The Melbourne-based company had been studying narmafotinib in combination with the widely used but aggressive mFOLFIRINOX regimen in patients with advanced pancreatic cancer. After eight patients were enrolled and treated, three experienced dose-limiting toxicities, all linked to the chemotherapy rather than the experimental therapy itself, the company said.
Narmafotinib, Amplia’s lead candidate targeting focal adhesion kinase, has not been associated with the observed safety issues.
Five of the eight participants will continue in the study, maintaining their treatment under close monitoring. Early signals of efficacy, while still preliminary, offer a measure of encouragement. Half of the patients achieved stable disease at their first scan, and one progressed to a partial response by the four-month mark. These results, though limited, hint at the therapeutic potential of narmafotinib when paired with more manageable treatment regimens.
Amplia said it will redirect its focus toward combinations that may better balance efficacy with patient tolerability.
In the ongoing ACCENT trial, narmafotinib is being evaluated alongside gemcitabine and Abraxane, a combination generally considered more tolerable. Early data from that study have already shown a response rate exceeding that of chemotherapy alone, along with promising progression-free survival outcomes.