On September 3, 2025 Amplia Therapeutics Limited (ASX: ATX) ("Amplia" or the "Company") reported that the first patient has been enrolled and has begun dosing in the company’s new pancreatic cancer trial (Press release, Amplia Therapeutics, SEP 3, 2025, View Source [SID1234655735]). The trial is exploring the combination of Amplia’s best-in-class FAK inhibitor narmafotinib with the chemotherapy FOLFIRINOX in newly diagnosed advanced pancreatic cancer patients.
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The trial is being conducted at two (2) sites in Australia that are already open and recruiting patients, and four (4) sites in the US that will shortly be open once final site approvals are obtained. The first stage of this trial will explore the safety, tolerability and pharmacokinetics of increasing daily doses of narmafotinib when combined with FOLFIRINOX given on its conventional two (2) week cycle. The dose-escalation is anticipated to be completed in Q1 2026.
Dr Chris Burns, Amplia’s CEO and Managing Director commented: "With dosing of the first patient, this trial is now officially underway. This is an important milestone in the development of narmafotinib and we thank everyone who has worked tirelessly to get us to this point." This ASX announcement was approved and authorised for release by the Board of Amplia Therapeutics.
About Narmafotinib
Narmafotinib (AMP945) is the company’s best-in-class inhibitor of the protein FAK, a protein over-expressed in pancreatic cancer and a drug target gaining increasing attention for its role in solid tumours. The drug, which is a highly potent and selective inhibitor of FAK, has shown promising data in a range of preclinical cancer studies. Narmafotinib is currently being investigated in the ACCENT clinical trial where it is dosed in combination with the chemotherapies gemcitabine and Abraxane in first-line patients with advanced pancreatic cancer. The trial has already achieved its desired outcome
in achieving a response rate of 31%, superior to chemotherapy alone. In particular, one (1) complete response and one (1) pathological complete response have been recorded in this study.
About the FOLFIRINOX Trial
This trial investigates narmafotinib in combination with the modified FOLFIRINOX chemotherapy regimen to explore the safety, tolerability, efficacy and pharmacokinetics of the combination in newly-diagnosed patients with advanced (metastatic) pancreatic cancer. The trial is entitled ‘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’ and is being conducted under an open IND from the US FDA.
Designed as a single-arm, open-label study, the trial will proceed in two parts, incorporating the principles of the FDA’s Project Optimus guidance for developing new oncology therapies1. Part A will explore a range of oral daily doses of narmafotinib (AMP945) in combination with modified FOLFIRINOX (administered every 14 days), for safety, tolerability, and pharmacokinetics. Part B of the trial is designed to identify the optimal daily dose of narmafotinib for future studies, by comparing two (2) doses identified from Part A, for safety, tolerability and efficacy.
The trial is being conducted initially at sites in Australia and the US. More information about the trial can be found at the Amplia Therapeutics website and at ClinicalTrials.gov under the identifier NCT07026279.
The Company has previously presented data from preclinical studies demonstrating that the addition of narmafotinib to FOLFIRINOX improves survival in animal models of pancreatic cancer compared to animals treated with FOLFIRINOX alone.