Amplia Therapeutics (ASX: ATX) is expanding its narmafotinib program into ovarian cancer with a new investigator-initiated PRROSE trial in partnership with ANZGOG.
This study will evaluate narmafotinib combined with standard chemotherapy, specifically carboplatin and paclitaxel, in patients with high-grade serous ovarian cancer.
The trial specifically targets patients who have shown a poor response to initial platinum-based therapy prior to interval debulking surgery.
While the primary emphasis of the PRROSE trial is safety, it will also involve extensive biomarker collection from tissue and blood samples to assess narmafotinib’s mechanism of action and its potential to improve post-surgical outcomes.
The trial is expected to enrol between 15 and 20 patients and is led by Dr Gwo Yaw Ho of Monash Health and Monash University.
Pancreatic Cancer Trial Hit by DLTs
In April 2026, Amplia Therapeutics halted further recruitment in its AMPLICITY trial, which was evaluating narmafotinib alongside mFOLFIRINOX in advanced pancreatic cancer.
The decision followed the occurrence of three protocol-defined dose-limiting toxicities (DLTs) after eight patients had been dosed.
Crucially, Amplia has stated that these toxicities were not attributed to narmafotinib but rather to the mFOLFIRINOX chemotherapy regimen.
Patients already enrolled in the study will continue their treatment with ongoing safety monitoring.
Following this, the company announced it would redirect resources to explore other combination strategies for narmafotinib, moving away from FOLFIRINOX based combinations.
ACCENT Trial Shows Encouraging Efficacy
Prior to the ovarian cancer announcement, Amplia reported updated, centrally reviewed data from its ACCENT Phase 1b/2a trial in March 2026.
This trial is investigating narmafotinib plus gemcitabine/Abraxane in advanced pancreatic cancer.
The updated results showed an improved complete response rate of 7.8% (5/64 patients).
The objective response rate (ORR) for all patients in the stages 1b/2a on the 400 mg dose was 35.9% (23/64).
Furthermore, the median overall survival (mOS) improved to 11.1 months, which the company positioned as outperforming historical benchmarks for gemcitabine/Abraxane.
