Amplia Starts Dose Escalation of Narmafotinib with FOLFIRINOX in Pancreatic Cancer
Amplia Therapeutics has commenced dosing the first patient in its new pancreatic cancer trial combining narmafotinib with FOLFIRINOX chemotherapy, marking a key milestone in its drug development journey.
- First patient dosed in Amplia’s pancreatic cancer trial
- Trial combines FAK inhibitor narmafotinib with FOLFIRINOX chemotherapy
- Conducted across sites in Australia and the US
- Dose escalation phase expected to complete by Q1 2026
- Trial aims to assess safety, tolerability, pharmacokinetics, and efficacy
Trial Launch Marks a Milestone
Amplia Therapeutics Limited (ASX – ATX) has announced the dosing of the first patient in its new clinical trial targeting advanced pancreatic cancer. This trial explores the combination of Amplia’s leading FAK inhibitor, narmafotinib, with the established chemotherapy regimen FOLFIRINOX. The commencement of dosing signals a significant step forward in the development of narmafotinib, a drug designed to improve outcomes in a notoriously difficult-to-treat cancer.
Trial Design and Scope
The study is being conducted at multiple sites, including two in Australia and four soon-to-open locations in the United States. It is structured as a single-arm, open-label Phase 1b/2a trial, focusing initially on the safety, tolerability, and pharmacokinetics of escalating doses of narmafotinib combined with FOLFIRINOX, which is administered every two weeks. The dose-escalation phase is anticipated to conclude in the first quarter of 2026, after which the trial will identify the optimal dose for further studies.
Scientific Rationale and Previous Data
Narmafotinib targets focal adhesion kinase (FAK), a protein overexpressed in pancreatic cancer cells and implicated in tumor progression. Preclinical studies have demonstrated that adding narmafotinib to FOLFIRINOX improves survival in animal models compared to chemotherapy alone. Additionally, Amplia’s ongoing ACCENT trial has shown promising response rates when narmafotinib is combined with other chemotherapies, reinforcing the potential of this approach.
Regulatory and Strategic Context
The trial is being conducted under an open Investigational New Drug (IND) application from the US Food and Drug Administration (FDA) and incorporates principles from the FDA’s Project Optimus initiative, which aims to optimize oncology drug development. This regulatory alignment underscores Amplia’s commitment to rigorous clinical evaluation and efficient development pathways.
Looking Ahead
Amplia’s CEO, Dr Chris Burns, highlighted the importance of this milestone, thanking the teams involved in reaching this stage. As the trial progresses, investors and observers will be keenly watching for safety and efficacy data that could validate narmafotinib’s promise and pave the way for larger pivotal studies in pancreatic cancer.
Bottom Line?
Amplia’s pancreatic cancer trial initiation sets the stage for critical data that could reshape treatment options.
Questions in the middle?
- How will narmafotinib’s safety profile hold up in combination with FOLFIRINOX?
- What efficacy signals will emerge from the dose-escalation phase by early 2026?
- How might this trial influence Amplia’s broader clinical development strategy and partnerships?