On April 6, 2026 Amplia Therapeutics Limited (ASX:ATX; OTCQB:INNMF), ("Amplia" or the "Company"), reported that it is halting further recruitment in the AMPLICITY clinical trial in advanced pancreatic cancer investigating the Company’s lead drug narmafotinib in combination with the chemotherapy regimen modified FOLFIRINOX (mFOLFIRINOX).
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Eight (8) patients have been dosed with daily narmafotinib in combination with the mFOLFIRINOX regimen administered on its routine cycle and doses. Three (3) events of protocol-defined dose-limiting toxicity (DLT) have been observed at this time, though importantly none have been attributed to narmafotinib and instead relate to the chemotherapy regimen. Five of the 8 patients remain on study and will continue to receive the narmafotinib – mFOLFIRINOX combination with continuing safety monitoring as before.
FOLFIRINOX has been one of the main chemotherapy regimens used in the treatment of pancreatic cancer patients who are generally fitter and have a higher performance status. It is recognized as being more aggressive and less well tolerated by patients compared to gemcitabine and Abraxane, the chemotherapies being investigated in combination with narmafotinib in the ongoing ACCENT study. However, Amplia anticipates an increasing preference for less toxic chemotherapeutic regimens in clinical practice and will therefore halt recruitment in AMPLICITY and focus its resources on exploring combinations other than with FOLFIRINOX.
Dr Chris Burns, CEO and Managing Director of Amplia, commented on the latest results: "The DLTs observed are very disappointing for the patients and their families; however, toxicity with FOLFIRINOX chemotherapy is well documented. Given these effects, and the evolving landscape for pancreatic cancer treatment, we will continue to build on our promising ACCENT trial data, as well as plan for additional studies with new, targeted agents being developed for pancreatic cancer."
While efficacy data from AMPLICITY is early, four of the eight patients in the trial have recorded stable disease at their first (2-month) scan, with one of these patients subsequently recording a partial response at their 4 -month scan. No other efficacy data is available at this time though updates will be reported in due course.
(Press release, Amplia Therapeutics, APR 6, 2026, View Source [SID1234664185])