Amplia Gains US Ethics Approval for Pancreatic Cancer Trial
Released
Released
Announcement PDF
ABN 16 165 160 841
ASX RELEASE
24 June 2025
AMPLIA RECEIVES US ETHICS CLEARANCE FOR PANCREATIC CANCER TRIAL
HIGHLIGHTS
•
Institutional Review Board (ethics) approval received to initiate Phase 2 clinical trial of
narmafotinib in the US
•
The trial will explore narmafotinib in combination with the chemotherapy FOLFIRINOX in
advanced pancreatic cancer patients
•
The trial will be undertaken at selected sites in the US and Australia
Amplia Therapeutics Limited (ASX: ATX) (“Amplia” or the “Company”) is pleased to announce that it
has received US ethics approval of the protocol for the forthcoming Phase 2 clinical trial of
narmafotinib in combination with the chemotherapy FOLFIRINOX.
The ethics approval was received from the central US Institutional Review Board (IRB). The Principal
Investigators for each selected US site will now submit to their local authorities for final approval to
commence the trial at their site. The Company is working with its contracted clinical trials organisation
to identify up to six (6) trial sites in the US. A separate ethics approval for two (2) clinical trial sites in
Australia is also being sought.
The open-label Phase 2a clinical trial will explore the combination of the Company’s FAK inhibitor
narmafotinib with the chemotherapy FOLFIRINOX in first-line patients with advanced pancreatic
cancer. This trial differs from the ACCENT trial currently underway in Australia and Korea where
narmafotinib is combined with the chemotherapies gemcitabine and Abraxane. FOLFIRINOX is a
chemotherapy cocktail of four drugs used in the treatment of advanced pancreatic cancer, and in the
US is the preferred treatment for newly diagnosed patients.
The focus of the new trial is identification of the optimal dose of daily, orally-dosed narmafotinib when
combined with FOLFIRINOX which is administered intravenously every two (2) weeks. It is anticipated
the trial will recruit 60-70 patients, depending on the number of dose-levels explored.
Dr Chris Burns, Amplia’s CEO and Managing Director commented: “Receiving the protocol approval
from the IRB is a critical step in initiating the US trial of narmafotinib in combination with FOLFIRINOX.
Importantly, results from this trial will complement the existing positive data emerging from our
current ACCENT trial, aiming to establish narmafotinib as the optimal combination partner for
chemotherapy in this challenging disease.”
This ASX announcement was approved and authorised for release by the Board of Amplia
Therapeutics.
Level 17, 350 Queen Street, Melbourne VIC 3000
Email info@ampliatx.com
www.ampliatx.com
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
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 undergoing a clinical trial (the ACCENT
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 superior to chemotherapy alone. In particular, 2 complete responses have
been recorded in this study.
About the FOLFIRINOX Trial
Narmafotinib, in combination with the modified FOLFIRINOX chemotherapy regimen, will 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 doses of narmafotinib (AMP945), taken once daily 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 the US and Australia.
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.
The Company will provide further updates on the trial as activity progresses.
Investor Contact:
Dr Chris Burns
Chief Executive Officer
chris@ampliatx.com
Media Contact:
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 Twitter
(@ampliatx) and LinkedIn.
1
https://www.fda.gov/about-fda/oncology-center-excellence/project-optimus
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