Amplia Therapeutics (ASX:ATX) has taken a step forward in its clinical expansion strategy, announcing the opening of two U.S. trial sites for its AMPLICITY pancreatic cancer study.
The move strengthens the company’s presence in the United States while broadening access to patients eligible for the trial.
The newly initiated sites, the University of California, Irvine, and the Cleveland Clinic, will soon begin recruiting patients, joining two Australian centres already enrolling participants in the study. Three additional U.S. sites are expected to open in the coming weeks, further accelerating the trial’s global rollout.
The AMPLICITY trial is evaluating narmafotinib, Amplia’s focal adhesion kinase (FAK) inhibitor, in combination with the modified FOLFIRINOX chemotherapy regimen for newly diagnosed patients with advanced pancreatic cancer. Conducted under an open Investigational New Drug (IND) application with the U.S. Food and Drug Administration, the Phase 1b/2a study is designed to assess safety, tolerability, pharmacokinetics, and preliminary efficacy of the combination therapy.
Pancreatic cancer remains one of the most challenging solid tumours to treat, particularly in advanced stages where therapeutic options are limited, and survival outcomes remain poor. FAK has emerged as an increasingly important target in oncology, especially in fibrotic cancers such as pancreatic and ovarian malignancies. Narmafotinib, a highly potent and selective inhibitor of FAK, has demonstrated promising activity in preclinical models and is currently being investigated in multiple clinical settings.
The AMPLICITY trial follows encouraging results from Amplia’s ACCENT study, which examined narmafotinib in combination with gemcitabine and Abraxan® in first-line advanced pancreatic cancer. That trial achieved a confirmed response rate of 35 per cent, exceeding the 23 per cent benchmark reported in the historical MPACT study for chemotherapy alone, along with an interim median progression-free survival of 7.7 months.
In AMPLICITY, the study will proceed in two stages consistent with the FDA’s Project Optimus principles for oncology drug development. Part A will explore escalating oral daily doses of narmafotinib combined with modified FOLFIRINOX, administered every 14 days, to determine safety and pharmacokinetic parameters. Part B will compare two selected dose levels to identify the optimal regimen for future trials.
Preclinical data have shown that adding narmafotinib to FOLFIRINOX significantly improves survival in animal models of pancreatic cancer compared with chemotherapy alone, providing a strong mechanistic rationale for the combination.
Chief Executive Officer Dr Chris Burns described the activation of the U.S. sites as a major step toward efficient enrolment and broader clinical visibility. Expanding into leading American institutions not only increases access to eligible patients but also enhances Amplia’s profile in one of the world’s most important biotechnology markets.