Amplia Therapeutics expands AMPLICITY pancreatic cancer trial footprint into the United States
Amplia Therapeutics has announced the opening of Amplia Therapeutics AMPLICITY US Trial Sites (ASX: ATX), with two US-based clinical sites now initiated and preparing to recruit patients for its pancreatic cancer investigation. The sites, University of California, Irvine and The Cleveland Clinic, join two existing Australian sites at Epworth Hospital Melbourne and Genesis Care Sydney. An additional three US sites are expected to open in the coming weeks, bringing the potential total to seven active recruitment locations.
The geographic expansion into the US healthcare system accelerates patient recruitment timelines and raises the company’s profile among US-based investors and potential partners. With five sites anticipated to be operational shortly, Amplia Therapeutics is positioned to enrol patients more efficiently across multiple jurisdictions.
What is a FAK inhibitor and why does it matter for pancreatic cancer?
Focal Adhesion Kinase (FAK) is a protein that becomes overexpressed in pancreatic cancer cells, where it contributes to tumour growth and resistance to standard treatments. Think of FAK as a signal that tells cancer cells to survive and spread. When FAK is blocked, cancer cells become more vulnerable to chemotherapy.
Narmafotinib is Amplia’s “best-in-class” FAK inhibitor designed to target this mechanism. By combining FAK inhibition with the chemotherapy regimen FOLFIRINOX, the company aims to improve outcomes for patients with advanced pancreatic cancer. FAK inhibitors represent an emerging class of cancer therapeutics, positioning Amplia in a growing market segment addressing significant unmet medical need in one of the most difficult-to-treat cancer types.
AMPLICITY trial design and pathway to results
The AMPLICITY trial follows a Phase 1b/2a design structured in two distinct parts. Part A serves as the dose exploration phase, testing multiple daily doses of narmafotinib combined with modified FOLFIRINOX (administered every 14 days) to assess safety, tolerability and pharmacokinetics. Part B is the dose optimisation phase, comparing two doses identified from Part A for safety, tolerability and efficacy.
The trial operates as a single-arm, open-label study and follows FDA Project Optimus guidance for oncology drug development. Amplia is conducting the investigation under an open Investigational New Drug (IND) application with the US FDA.
| Trial Component | Purpose |
|---|---|
| Part A | Dose exploration for safety, tolerability, pharmacokinetics |
| Part B | Dose optimisation comparing two doses for efficacy |
The structured approach aligns with FDA guidance, potentially smoothing the regulatory pathway if results are positive. More information about the trial can be found at amplicitytrial.com and on ClinicalTrials.gov under identifier NCT07026279.
Preclinical foundation supports the combination approach
Amplia has previously presented preclinical data demonstrating that narmafotinib plus FOLFIRINOX significantly improved survival in animal models of pancreatic cancer compared to FOLFIRINOX alone. This preclinical validation supports the scientific rationale underpinning the clinical programme and provides credibility for the combination strategy being tested in AMPLICITY.
CEO perspective on US expansion
Management has explicitly linked the Amplia Therapeutics AMPLICITY US Trial Sites expansion to both operational efficiency and investor relations objectives.
Dr Chris Burns, CEO
“These two excellent clinical trial sites in the US help to significantly expand our potential patient base for the AMPLICITY trial, while also contributing to enhancing our presence in the United States both from a clinical and investor perspective. With these two sites, and shortly an additional three sites, we expect to be able to enrol the ongoing study as efficiently as possible.”
The comment reflects the dual benefit of geographic expansion: accelerated patient access for the trial and enhanced visibility among US-based institutional investors and potential pharmaceutical partners. The US represents the world’s largest oncology market, making in-country clinical presence strategically valuable for future commercialisation discussions.
Amplia’s broader pancreatic cancer pipeline
AMPLICITY is not Amplia’s only pancreatic cancer trial. The company is also conducting the ACCENT trial, which investigates narmafotinib in combination with gemcitabine and Abraxane in first-line advanced pancreatic cancer patients.
ACCENT has already achieved notable milestones:
- Primary endpoint achieved
- 35% confirmed response rate (versus 23% benchmark in the MPACT study)
- Interim median progression-free survival (PFS) of 7.7 months reported
The positive data from ACCENT provides validation for narmafotinib’s clinical potential and de-risks the broader development programme, including AMPLICITY. When a drug candidate demonstrates efficacy in one trial design, confidence in related studies typically increases among investors and pharmaceutical industry observers.
What’s next for the AMPLICITY trial
Near-term milestones centre on the opening of three additional US sites in the coming weeks. With seven potential recruitment locations across Australia and the United States, Amplia expects to accelerate enrolment progress throughout 2025.
Further information regarding trial eligibility and participating sites can be found at amplicitytrial.com and ClinicalTrials.gov (NCT07026279). The company has not provided specific guidance on when interim data from AMPLICITY might become available, as the trial is currently in its dose-finding phase.
The expansion into the US healthcare system represents a significant operational step for Amplia Therapeutics, providing access to a larger patient population and establishing clinical credibility in the world’s largest oncology market.
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