Amplia and ANZGOG Finalise Protocol for Ovarian Cancer Trial
Released
Released
Announcement PDF
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
15 Sep 2026
ASX RELEASE
AMPLIA AND ANZGOG FINALISE PROTOCOL FOR OVARIAN CANCER CLINICAL TRIAL
HIGHLIGHTS
• The PRROSE trial will investigate the combination of narmafotinib with standard of care chemotherapy
in patients with advanced ovarian cancer
• Following close collaboration between ANZGOG and Amplia the clinical trial protocol has been finalised
• Ethics and site governance approvals will be submitted with the goal of opening trial sites before the
end of 2026
Melbourne, Australia: Amplia Therapeutics Limited (ASX:ATX; OTCQB:INNMF), (“Amplia” or the
“Company”), and the Australia New Zealand Gynaecological Oncology Group (ANZGOG) are
pleased to announce that the clinical trial protocol for the planned PRROSE Phase 2 ovarian cancer
study has been finalised, marking an important milestone toward study commencement.
The ANZGOG and Amplia teams have worked collaboratively over the last three months to finalise
the PRROSE trial protocol. With this completed, submission for ethics and site governance
approvals will be undertaken, with site activation and patient recruitment planned before the end
of 2026.
The PRROSE trial will explore the combination of Amplia’s FAK inhibitor, narmafotinib, in
combination with standard-of-care chemotherapy, in women with high-grade serous ovarian
cancer (HGSOC). The study will focus on patients whose tumours demonstrate a poor response
to chemotherapy prior to planned interval debulking surgery, a group with a significant unmet
medical need.
The study will be led by Dr Gwo Yaw Ho of Monash Health and Monash University and will be
sponsored and coordinated by ANZGOG. Approximately 26 patients across selected clinical sites
in Australia and New Zealand are expected to be enrolled into the trial.
Dr Chris Burns, CEO and Managing Director of Amplia, commented: “This is an important study
for a patient population who currently have limited treatment options. We are grateful to the
ANZGOG team, working closely with our clinical team at Amplia, for their diligent efforts to
complete the trial protocol. We now look forward to finalising ethics submissions with the goal of
opening trial sites before the end of the year.”
Dr Gwo Yaw Ho, Lead Investigator, said: “Completion of the study protocol enables us to move
towards evaluating this promising therapeutic approach in patients with high-grade serous
ovarian cancer who are at increased risk of poor outcomes. We look forward to initiating the study
and exploring the potential clinical benefit of combining narmafotinib with chemotherapy.”
The PRROSE study was first announced in May 20261
and is designed to explore the potential
role of FAK inhibition in improving outcomes for patients with ovarian cancer.
This ASX announcement was approved and authorised for release by ANZGOG and 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
Amplia Media Contact:
Tom Trezona, H^CK Acting MD
tom@hck.digital
+61 411 235 692
ANZGOG Media Contact:
Monique Cerreto
Monique.cerreto@anzgog.org.au
+61 416 282 464
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 the Australia New Zealand Gynaecological Oncology Group (ANZGOG)
ANZGOG is the peak national gynaecological cancer research organisation in Australia and New Zealand.
It’s more than 1650 members work in hospitals, research institutions, universities, government, the non-
profit sector, and industry. Members include surgeons, physicians, radiation oncologists, psychologists,
social workers, nurses, trial coordinators, pure researchers, allied health professionals and cancer
consumers who are based in all states of Australia and regions in New Zealand. ANZGOG’s vision is
Advancing research, saving lives and its mission is to improve outcomes and quality of life for everyone
with a lived experience of gynaecological cancer by conducting and promoting clinical trials and
multidisciplinary research. For more information, visit www.anzgog.org.au and follow ANZGOG on
LinkedIn
About the PRROSE trial
The PRROSE trial will evaluate the safety of narmafotinib in combination with standard-of-care
chemotherapy (carboplatin and paclitaxel) in HGSOC patients who have demonstrated poor response to
up-front standard-of-care platinum-based chemotherapy prior to planned interval debulking surgery.
Approximately one in five ovarian cancer patients do not respond adequately to initial chemotherapy,
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ASX Announcement May 8 2026
limiting their ability to undergo surgery and contributing to poor clinical outcomes. This study is designed
to address this significant unmet medical need. The study will therefore also explore whether the addition
of narmafotinib can increase the proportion of patients eligible for successful surgical resection.
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 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 achieved its desired outcome in achieving an objective response rate of
36%, superior to chemotherapy alone, and a mOS of 11.1 months has been reported.
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