On July 29, 2025 Amplia Therapeutics Limited (ASX: ATX) ("Amplia" or the "Company") reported that it has received Australian ethics approval for the Phase 2 clinical trial of narmafotinib in combination with the chemotherapy FOLFIRINOX (Press release, Amplia Therapeutics, JUL 29, 2025, View Source [SID1234654610]).

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The ethics approval received covers two (2) clinical trial sites in Australia and follows US ethics approval received last month.

The open-label Phase 2a clinical trial will explore the combination of the Company’s FAK inhibitor narmafotinib with the chemotherapy FOLFIRINOX in newly diagnosed patients with advanced pancreatic cancer. Commonly employed in the USA for advanced pancreatic cancer, FOLFIRINOX chemotherapy is also utilized in Australia, particularly for younger patients.

The focus of the new trial is identification of the optimal daily dose of narmafotinib when combined with FOLFIRINOX which is administered intravenously every two (2) weeks. The trial will be run in two stages: the first being a dose exploration stage involving up to 27 patients, and the second comparing two doses of narmafotinib across 40 patients.

Dr Chris Burns, Amplia’s CEO and Managing Director commented: "With ethics approval now obtained in both Australia and the US, we look forward to initiating recruitment of the trial."