Amplia Therapeutics (ASX:ATX) has received Australian ethics approval for the Phase 2 clinical trial of narmafotinib in combination with the chemotherapy FOLFIRINOX.
The company said ethics approval received covers two clinical trial sites in Australia and follows the US ethics approval received last month.
The open-label Phase 2a clinical trial will explore the combination of Amplia's FAK inhibitor narmafotinib with the chemotherapy FOLFIRINOX in newly diagnosed patients with advanced pancreatic cancer. Commonly employed in the US for advanced pancreatic cancer, FOLFIRINOX chemotherapy is also utilised in Australia, particularly for younger patients.
The focus of the new trial is the identification of the optimal daily dose of narmafotinib when combined with FOLFIRINOX which is administered intravenously every two weeks. The trial will be run in two stages. The first stage is a dose exploration stage involving up to 27 patients, and the second will compare two doses of narmafotinib in 40 patients.
Dr Chris Burns, Amplia’s CEO and Managing Director, said, “With ethics approval now obtained in both Australia and the US, we look forward to initiating recruitment of the trial.”