FIRST PATIENT DOSED IN NEW PANCREATIC CANCER TRIAL
Released
Released
Announcement PDF
4 SEPTEMBER 2025
ASX RELEASE
FIRST PATIENT DOSED IN NEW PANCREATIC CANCER TRIAL
HIGHLIGHTS
•
The first patient has been enrolled and has begun dosing in Amplia Therapeutics' new
pancreatic cancer trial
•
The trial is investigating the combination of Amplia's FAK inhibitor, narmafotinib, with the
chemotherapy FOLFIRINOX in patients with newly diagnosed metastatic pancreatic cancer
Melbourne, Australia: Amplia Therapeutics Limited (ASX: ATX) (“Amplia” or the “Company”) is pleased
to announce that the first patient has been enrolled and has begun dosing in the company's new
pancreatic cancer trial. 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.
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 doseescalation 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 overexpressed in pancreatic cancer and a drug target gaining increasing attention for its role in solid
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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 therapies 1. 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.
Investor Contact
Media Contact
Dr Chris Burns
Chief Executive Officer
chris@ampliatx.com
H^CK Director, Haley Chartres
haley@hck.digital
+61 423 139 163
About Amplia Therapeutics Limited
Amplia Therapeutics Limited is an Australian pharmaceutical company advancing a pipeline of Focal Adhesion
Kinase (FAK) inhibitors for cancer and fibrosis. FAK is an increasingly important target in the field of cancer and
Amplia has a particular development focus in fibrotic cancers such as pancreatic and ovarian cancer. FAK also
plays a significant role in a number of chronic diseases, such as idiopathic pulmonary fibrosis (IPF). For more
information visit www.ampliatx.com and follow Amplia on X (formerly Twitter) (@ampliatx) and LinkedIn.
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