Melbourne, Australia — February 11, 2026 — Leads & Copy — Amplia Therapeutics Limited (ASX:ATX; OTCQB:INNMF) has initiated two U.S.-based sites for its AMPLICITY trial in pancreatic cancer, joining two Australian sites already recruiting patients.
The sites, at the University of California, Irvine, and The Cleveland Clinic, will soon begin recruitment activities. Three additional U.S. sites are expected to open in the coming weeks.
The AMPLICITY trial is studying Amplia’s drug, narmafotinib, in advanced pancreatic cancer patients.
Amplia CEO Dr. Chris Burns said the U.S. sites will expand the patient base for the AMPLICITY trial and enhance the company’s presence in the United States from a clinical and investor perspective. He thanked the trial sites and clinical teams for their efforts in completing the pre-trial activities.
The AMPLICITY trial is investigating narmafotinib, a FAK inhibitor, combined with the chemotherapy FOLFIRINOX in advanced pancreatic cancer. The trial is open at Epworth Hospital (Melbourne) and Genesis Care (Sydney) in Australia. Details can be found at amplicitytrial.com.
Amplia Therapeutics is an Australian pharmaceutical company developing Focal Adhesion Kinase (FAK) inhibitors for cancer and fibrosis, focusing on fibrotic cancers like pancreatic and ovarian cancer. FAK is also relevant in chronic diseases like idiopathic pulmonary fibrosis (IPF).
Narmafotinib (AMP945) is Amplia’s FAK inhibitor, showing promise in preclinical cancer studies. It is being studied in two pancreatic cancer clinical trials. The ACCENT trial, investigating narmafotinib with gemcitabine and Abraxane®, achieved a confirmed response rate of 35%, compared to 23% in the MPACT study for gemcitabine and Abraxane alone. An interim median PFS of 7.7 months was reported.
The AMPLICITY trial assesses the safety, tolerability, efficacy, and pharmacokinetics of narmafotinib with modified FOLFIRINOX in newly diagnosed patients with advanced pancreatic cancer. The trial, titled “A Phase 1b/2a, Multicenter, Open Label Study of the Safety, Efficacy and Pharmacokinetics of narmafotinib in Combination with modified FOLFIRINOX in Pancreatic Cancer Patients,” is being conducted under an open IND from the US FDA.
The trial is a single-arm, open-label study in two parts, following FDA’s Project Optimus guidance. Part A will explore doses of narmafotinib with modified FOLFIRINOX for safety, tolerability, and pharmacokinetics.
Part B will identify the optimal daily dose of narmafotinib by comparing two doses from Part A for safety, tolerability, and efficacy.
The trial is initially at sites in Australia and the US. More information is available at the Amplia Therapeutics website; ClinicalTrials.gov (identifier NCT07026279); and amplicitytrial.com.
Preclinical studies showed that narmafotinib added to FOLFIRINOX improved survival in animal models of pancreatic cancer compared to FOLFIRINOX alone.
Source: Amplia Therapeutics Limited
