US Sites For AMPLICITY Pancreatic Cancer Trial Open
ABN 16 165 160 841
+61 (0) 3 9123 1140 | info@ampliatx.com
Level 5, 90 William Street, Melbourne VIC 3000 Australia
www.ampliatx.com
11 FEBRUARY 2026
ASX RELEASE
AMPLIA THERAPEUTICS ANNOUNCES OPENING OF US SITES FOR AMPLICITY PANCREATIC
CANCER TRIAL
HIGHLIGHTS
• Two US-based sites have completed trial initiation activities for the AMPLICITY trial in pancreatic cancer
• These sites join the two Australian sites already open and recruiting patients
• Three additional US sites are expected to be open in the coming weeks
Melbourne, Australia: Amplia Therapeutics Limited (ASX:ATX; OTCQB:INNMF), (“Amplia” or the
“Company”), announces that two (2) sites in the US have been initiated and will shortly be commencing
recruitment activities for the AMPLICITY trial.
The two sites – University of California, Irvine (Irvine, Calif.) and The Cleveland Clinic (Cleveland, Oh.) – join
the two (2) sites already open in Australia as part of the Company’s AMPLICITY trial, which is investigating
Amplia’s lead drug, narmafotinib, in advanced pancreatic cancer patients. An additional three (3) sites in
the US will be initiated in the near future as recruitment to the trial continues.
Dr Chris Burns, CEO of Amplia, commented: “These two excellent clinical trial sites in the US help to
significantly expand our potential patient base for the AMPLICITY trial, while also contributing to enhancing
our presence in the United States both from a clinical and investor perspective. With these two sites, and
shortly an additional three sites, we expect to be able to enrol the ongoing study as efficiently as possible.
We thank the trial sites and clinical teams for their diligent efforts in completing the pre-trial activities.”
The AMPLICITY trial is investigating narmafotinib, the Company’s best-in-class FAK inhibitor, in
combination with the chemotherapy FOLFIRINOX in advanced pancreatic cancer. The trial is already open
at two sites in Australia, at the Epworth Hospital (Melbourne) and Genesis Care (Sydney). Further
information regarding the AMPLICITY trial can be found at the trial website amplicitytrial.com.
This ASX announcement was approved and authorised for release by the Board of Amplia Therapeutics.
Investor Contact:
Dr Chris Burns
Chief Executive Officer
chris@ampliatx.com
U.S. Contact:
Robert Giordano
rjgiordano@ggrouplifesciences.com
+1 917 327 3938
Media Contact:
H^CK Director, Haley Chartres
haley@hck.digital
+61 423 139 163
U.S. Media:
media@ampliatx.com
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 (@ampliatx) and
LinkedIn.
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 two clinical trials in pancreatic cancer. The
most advanced clinical trial (ACCENT) investigates a combination with the chemotherapies gemcitabine and
Abraxane®
in first-line patients with advanced pancreatic cancer. The trial has already achieved its primary
endpoint in achieving a confirmed response rate of 35%, superior to 23% reported in the benchmark MPACT
study for gemcitabine and Abraxane alone. An interim median PFS of 7.7 months has also been reported.
About AMPLICITY
The AMPLICITY trial explores the safety, tolerability, efficacy and pharmacokinetics of the combination of
narmafotinib with the chemotherapy regimen known as modified FOLFIRINOX in newly-diagnosed patients
with advanced 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 . Part A will explore a range
of oral daily doses of narmafotinib 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; ClinicalTrials.gov under the identifier NCT07026279; and at
amplicitytrial.com.
The Company has previously presented data from preclinical studies demonstrating that the addition of
narmafotinib to FOLFIRINOX significantly improves survival in animal models of pancreatic cancer
compared to animals treated with FOLFIRINOX alone.
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