Amplia Therapeutics clinical trial update: two studies running, three in late-stage start-up
Amplia Therapeutics (ASX:ATX; OTCQB:INNMF) has updated the market on narmafotinib, its lead drug, with two ongoing studies underway and three clinical trials in late-stage start-up. The update covers the ACCENT, AMPLICITY, ACCENT-Mini and PRROSE trials.
The four highlights from the 22 October 2026 release were:
- ACCENT: one patient remains on study, with 2 patients having completed 24 months on study.
- AMPLICITY: one patient remains on study, with 1 confirmed and 1 unconfirmed partial response (PR) recorded to date.
- ACCENT-Mini: ethics approval is expected imminently.
- PRROSE: ethics approval has been submitted.
For investors, the pipeline is moving from mature data into new trials. ACCENT-Mini data is also intended to feed a protocol submission to the US Food and Drug Administration (FDA).
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ACCENT and AMPLICITY: what the data shows
ACCENT trial: durable responses
The ACCENT trial is investigating narmafotinib combined with gemcitabine and nab-paclitaxel (Abraxane) chemotherapy in newly diagnosed metastatic pancreatic cancer patients. Amplia said mature data from the study, previously reported, demonstrated promising efficacy, what it described as “an unprecedented level of confirmed complete responses,” and good tolerability.
One patient remains on study (currently at 19 months), while two patients have completed 2 years on study.
A genetic analysis of tumours from a subset of patients suggests responses do not appear to depend on commonly assessed tumour characteristics, including mutations in the KRAS gene. KRAS (Kirsten rat sarcoma viral oncogene homolog) is a gene mutated in ~85% of pancreatic cancer patients.
Additional biomarker studies are underway, and a scientific paper describing the trial and data is currently being drafted. The company’s background notes cite a response rate of 36%, superior to chemotherapy alone, and a median overall survival (mOS) of 11.1 months.
Dr Jason Lickliter, Chief Medical Officer
“It is exciting to be moving forward with these trials as the Company builds on the positive clinical data from the ACCENT trial and the promising preclinical data underpinning the PRROSE and Lilly combination studies.”
AMPLICITY trial: early signals, recruitment halted
The AMPLICITY trial is investigating narmafotinib combined with modified FOLFIRINOX chemotherapy in newly diagnosed metastatic pancreatic cancer patients. Recruitment was halted after three dose-limiting toxicities, attributed to the chemotherapy, were observed (ASX announcement, 7 April 2026).
The trial has recorded 1 confirmed partial response and 1 unconfirmed partial response, and one patient remains on study.
Trial summary
| Trial | Combination | Status | Key data |
|---|---|---|---|
| ACCENT | Narmafotinib with gemcitabine and Abraxane | One patient remains on study (19 months) | 2 patients completed 24 months on study |
| AMPLICITY | Narmafotinib with modified FOLFIRINOX | Recruitment halted; one patient remains on study | 1 confirmed and 1 unconfirmed PR |
| ACCENT-Mini | Daily narmafotinib with gemcitabine and Abraxane | Ethics approval submitted, expected imminently | Safety and pharmacokinetic data due late Q1/early Q2 2027 |
| PRROSE | Narmafotinib with carboplatin and paclitaxel | Protocol finalised; ethics approval submitted | Not applicable |
Understanding FAK inhibitors and the registrational pathway
Focal Adhesion Kinase (FAK) is a protein that Amplia describes as over-expressed in pancreatic cancer and a drug target gaining increasing attention for its role in solid tumours. Amplia has a particular development focus in fibrotic cancers such as pancreatic and ovarian cancer. A FAK inhibitor is a drug designed to block this protein’s activity.
A registrational study is a trial intended to support a regulatory submission for drug approval. In this case, safety and pharmacokinetic data (how the body absorbs and processes a drug) from ACCENT-Mini will be included in the company’s protocol submission to the FDA for the registrational study of narmafotinib plus gemcitabine and Abraxane in pancreatic cancer.
That makes ACCENT-Mini the bridge between the early data and a potential late-stage trial.
Investors exploring the registrational pathway can read our detailed coverage of the FDA-aligned ACCENT-Mini trial design, which sets out the 12-patient daily dosing study, its Australian sites, and the orphan and fast track designations held by narmafotinib.
What’s next: ACCENT-Mini, PRROSE and the Lilly combination
The announcement points to four upcoming developments:
- ACCENT-Mini: daily narmafotinib with gemcitabine and Abraxane. Three clinical trial sites in Australia have been selected, and ethics approval has been submitted and is expected imminently (ASX announcement, 19 May 2026).
- ACCENT-Mini data: safety and pharmacokinetic data will be available late Q1/early Q2 2027 and will be included in the protocol submission to the FDA for the registrational study of narmafotinib plus gemcitabine and Abraxane in pancreatic cancer.
- PRROSE: narmafotinib with carboplatin and paclitaxel in ovarian cancer patients who have had limited or no response to chemotherapy in the initial treatment setting. The protocol is finalised and ethics approval is submitted, with the study run as a sponsored study by ANZGOG at sites in Australia and New Zealand (ASX announcement, 8 May 2026).
- Lilly combination: narmafotinib with Lilly’s investigational kRAS G12C inhibitor olomorasib in patients with advanced non-small cell lung cancer. A separate announcement will be released to the market (earlier ASX announcement, 4 August 2026).
Taken together, the update shows Amplia broadening narmafotinib across pancreatic, ovarian and lung cancer while building toward a registrational study in pancreatic cancer.
Ready to Learn More About Amplia’s Narmafotinib Pipeline?
Amplia Therapeutics is advancing narmafotinib from mature ACCENT data into ACCENT-Mini, PRROSE and a Lilly combination study, with a registrational pathway in pancreatic cancer in view. The pipeline now spans pancreatic, ovarian and lung cancer.
Investors can explore the Amplia Therapeutics website to review the company’s clinical programs and development strategy. Visit the site to see how narmafotinib could progress towards late-stage trials.