Amplia Therapeutics (ASX:ATX) has dosed the first patient in its new pancreatic cancer trial, marking the official start of a study testing its lead FAK inhibitor narmafotinib (AMP945) in combination with chemotherapy.
The trial, which is now open at two Australian sites and awaiting final approvals for four US centres, is enrolling newly diagnosed patients with advanced pancreatic cancer. It will assess safety, tolerability and pharmacokinetics of daily narmafotinib alongside the chemotherapy regimen FOLFIRINOX, given on its standard two-week cycle. The initial dose-escalation phase is expected to wrap up in the first quarter of 2026.
“This is an important milestone in the development of narmafotinib,” CEO Dr Chris Burns said. “We thank everyone who has worked tirelessly to get us to this point.”
Narmafotinib, described by the company as best-in-class, targets the protein FAK, which is overexpressed in pancreatic cancer and is drawing increasing attention as a drug target in solid tumours. Amplia is already testing it in the ACCENT trial, where the drug combined with gemcitabine and Abraxane delivered a 31 per cent response rate, better than chemotherapy alone, including one complete response and one pathological complete response.
The new study, formally titled 'A Phase 1b/2a, Multicenter, Open Label Study of the Safety, Efficacy and Pharmacokinetics of Narmafotinib in Combination with Modified FOLFIRINOX in Pancreatic Cancer Patients', will run under an open IND with the US FDA.
It will proceed in two parts, aligned with the FDA’s Project Optimus principles. Part A will test escalating oral doses of narmafotinib with modified FOLFIRINOX to assess safety and drug behaviour. Part B will then compare two doses from Part A to select the optimal regimen for future studies, looking at safety, tolerability and early efficacy.
Amplia has previously shown in preclinical studies that adding narmafotinib to FOLFIRINOX improved survival in animal models compared to chemotherapy alone.
Details of the trial, which is recruiting across Australia and soon in the US, are available at ClinicalTrials.gov (NCT07026279).