Amplia and ANZGOG Finalise Protocol

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 2026 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.