Amplia's Pancreatic Cancer Trial Expands to US, Boosting Hope for New Therapy

MELBOURNE, Australia – February 11, 2026 – Australian biotech firm Amplia Therapeutics has initiated a significant expansion of its clinical trial for a promising pancreatic cancer drug into the United States, a move that could accelerate the search for new treatments against one of the world’s deadliest cancers. The company announced that two prestigious US medical centers have been activated for its AMPLICITY trial, which is evaluating the investigational drug narmafotinib in patients with advanced pancreatic cancer.

A Strategic Leap Across the Pacific

The first two US sites to begin trial initiation activities are the University of California, Irvine, and The Cleveland Clinic. These centers join two existing Australian sites—the Epworth Hospital in Melbourne and Genesis Care in Sydney—that are already recruiting patients. Amplia also confirmed that three additional US sites are expected to open in the coming weeks, a clear signal of the company's strategy to expedite enrollment and advance the drug's development timeline.

This expansion is more than just a logistical step; it represents a critical strategic push into the world's largest pharmaceutical and healthcare market. By establishing a clinical footprint in the US, Amplia not only gains access to a larger and more diverse patient population but also increases its visibility among American investors and key opinion leaders in oncology.

“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,” said Dr. Chris Burns, CEO of Amplia Therapeutics, in the official announcement. “With these two sites, and shortly an additional three sites, we expect to be able to enroll the ongoing study as efficiently as possible.”

For a company with a market capitalization of approximately AUD 61.5 million, this international expansion is an ambitious and necessary undertaking. Clinical trials are notoriously expensive and time-consuming, and accelerating patient recruitment is paramount to achieving results efficiently and managing cash burn. With a reported AUD 31.5 million in cash at the end of 2025, bolstered by a recent capital raise, Amplia appears well-positioned to fund this crucial phase of development into 2027.

Targeting a Tenacious Tumor Microenvironment

The AMPLICITY trial is investigating narmafotinib in combination with modified FOLFIRINOX, a potent multi-drug chemotherapy regimen often used as a first-line treatment for advanced pancreatic cancer in patients who are fit enough to tolerate it. The scientific rationale behind this combination lies in narmafotinib’s unique mechanism of action.

Narmafotinib is a highly selective inhibitor of Focal Adhesion Kinase (FAK), an enzyme that has garnered increasing attention in oncology. In pancreatic cancer, the tumor is often protected by a dense, fibrous fortress known as the stroma. This fibrotic microenvironment acts as a physical barrier, preventing chemotherapy drugs from effectively reaching and killing cancer cells, and also contributes to immune suppression and metastasis.

FAK is a key player in building and maintaining this protective stroma. By inhibiting FAK, narmafotinib is designed to dismantle this barrier, making the tumor more permeable and vulnerable to the effects of chemotherapy. Preclinical studies conducted by Amplia have already shown that adding narmafotinib to FOLFIRINOX led to significantly improved survival in animal models of pancreatic cancer compared to FOLFIRINOX alone, providing a strong foundation for the current human trials.

Building on a Foundation of Promising Data

The optimism surrounding the AMPLICITY trial is not based on preclinical data alone. It is heavily supported by encouraging results from another of Amplia's ongoing studies, the ACCENT trial. This separate trial evaluates narmafotinib in combination with a different chemotherapy standard-of-care, gemcitabine and Abraxane®, also in first-line patients with advanced pancreatic cancer.

Results from the ACCENT trial have been highly promising. The study met its primary endpoint, demonstrating a confirmed objective response rate (ORR) of 35% in patients treated with the narmafotinib combination. This figure significantly outperforms the 23% ORR reported in the historical MPACT study, which established gemcitabine and Abraxane as a standard of care. Furthermore, interim data from ACCENT showed a median progression-free survival (PFS) of 7.6 months, a notable improvement over the 5.5-month PFS seen in the MPACT trial.

These positive signals earned narmafotinib a Fast Track Designation from the U.S. Food and Drug Administration (FDA), a program designed to facilitate the development and expedite the review of drugs that treat serious conditions and fill an unmet medical need. By now testing narmafotinib with FOLFIRINOX in the AMPLICITY trial, Amplia is systematically exploring its drug's potential across the two primary chemotherapy backbones used in pancreatic cancer, a comprehensive strategy aimed at maximizing its potential clinical utility.

The High Stakes of Pancreatic Cancer Drug Development

The urgent need for innovation in pancreatic cancer cannot be overstated. The disease has one of the lowest survival rates of all cancers, with an overall five-year survival rate hovering around a dismal 12-13%. For patients diagnosed with metastatic disease, that figure plummets to just over 3%. Even with modern chemotherapy regimens like FOLFIRINOX and gemcitabine/Abraxane, the median overall survival for many patients remains under a year.

Developing new drugs in this space is a high-risk, high-reward endeavor, a reality reflected in the volatility of Amplia's stock (ASX: ATX). Despite positive clinical news, the company's share price has seen fluctuations, underscoring investor awareness of the long and arduous path to drug approval and commercialization.

The design of the AMPLICITY trial itself reflects a modern, rigorous approach to oncology research. The Phase 1b/2a study incorporates principles from the FDA's Project Optimus initiative, which guides companies to identify the optimal dose that maximizes efficacy while minimizing toxicity early in development. The trial's first part will focus on determining the safest and most effective dose of narmafotinib to use with FOLFIRINOX. The second part will then compare two selected doses to confirm the optimal choice for future, larger studies. This careful, data-driven methodology is essential for navigating the complex challenges of developing a new therapy for such a devastating disease.