What is the new clinical trial announced by Amplia Therapeutics (ASX:ATX)?

Amplia Therapeutics has partnered with the Australia New Zealand Gynaecological Oncology Group (ANZGOG) to launch the ORROSE trial. This study evaluates the company's lead drug candidate, narmafotinib, in combination with standard chemotherapy for patients with high-grade serous ovarian cancer (HGSOC).

Why is narmafotinib significant for Amplia Therapeutics (ASX:ATX) shareholders?

Narmafotinib is Amplia’s lead drug candidate and a Focal Adhesion Kinase (FAK) inhibitor. The drug aims to break down the fibrous nature of certain tumours that typically block chemotherapy from being effective.

What is the scale and timeline of the ORROSE trial?

The investigator-initiated trial is led by Dr Gwo Yaw Ho and aims to enrol approximately 15 to 20 patients across major hospitals in Australia and New Zealand. While specific completion dates aren't mentioned, the small patient cohort suggests an intensive Phase 1/2 style focus on safety and biomarker data.

How does this news affect the investment thesis for Amplia Therapeutics (ASX:ATX)?

This partnership diversifies Amplia’s clinical pipeline by moving into ovarian cancer, reducing the company's single-indication risk associated with pancreatic cancer. It demonstrates that the FAK-inhibition strategy has broader oncology applications, which could increase the company's appeal for future licensing deals or partnerships.

What are the key risks for investors following the ORROSE trial announcement?

The primary risk is clinical failure, as roughly 80% of ovarian cancer patients in this category do not respond well to existing treatments, making this a difficult "unmet need" to solve. Additionally, as a small-cap biotech, Amplia may require further capital raisings to fund extended trials if the ORROSE study requires expansion.

What specific medical outcome is the ORROSE trial trying to achieve?

The trial aims to increase the proportion of patients eligible for successful surgical resection (the surgical removal of a tumour). By using narmafotinib to inhibit FAK, the team hopes to make tumours more susceptible to chemotherapy, shrinking them enough for surgeons to operate. Improved post-surgical outcomes are the ultimate benchmark for the study's success.

Amplia and ANZGOG launch new ovarian cancer trial

Written by Heidi Cuthbert Published May. 8 2026Last Updated May. 8 2026

Melbourne-based Amplia Therapeutics (ASX:ATX) has partnered with the Australia New Zealand Gynaecological Oncology Group to launch a new clinical trial targeting high-grade serous ovarian cancer.

The study, titled the ORROSE trial, will evaluate the safety and efficacy of Amplia’s lead drug candidate, narmafotinib, when used in combination with standard-of-care chemotherapy.

The collaboration marks a critical step forward in addressing the unmet medical needs of patients who show a poor response to initial platinum-based treatments.

Led by Dr Gwo Yaw Ho of Monash Health and Monash University, the investigator-initiated trial aims to enrol between 15 and 20 patients across major hospitals in Australia and New Zealand.

The primary focus is on the role of focal adhesion kinase inhibition. Research indicates that HGSOC tumours often exhibit high levels of FAK expression and a fibrous nature, which can act as a barrier to conventional therapies.

By introducing narmafotinib—a best-in-class FAK inhibitor—the research team hopes to improve post-surgical outcomes and increase the proportion of patients eligible for successful surgical resection.

Dr Chris Burns, CEO of Amplia, expressed optimism regarding the study’s biological rationale, noting that the trial will also collect extensive tissue and blood biomarkers to further characterise narmafotinib’s mechanism of action.

At the time of reporting, Amplia Therapeutics' share price was $0.14.