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Montserrat

Amplia Therapeutics Limited

Amplia Therapeutics is developing a class of drug called a FAK inhibitor. If you have been diagnosed with pancreatic cancer you may be eligible to participate in our clinical trial. The ACCENT trial will test if narmafotinib helps people with pancreatic cancer have a better response to standard of care chemotherapies gemcitabine and nab-paclitaxel.

The ACCENT Clinical Trial (AMP945-PC-201) has strict entry criteria. Please note, Amplia is not recruiting patients directly and all enquiries for involvement must be made via the clinical trial sites.

Clinical trials provide a pathway to determine the effectiveness of a treatment or therapy related to the diagnosis, prevention or management of a disease or condition. 

Before treatments can be used by the general public they must undergo a series of clinical trials, called phases, and be approved by relevant regulatory agencies (such as the FDA in the United States and the TGA in Australia). There are typically four phases of clinical trials starting with Phase 1 which focuses on the safety and appropriate dose of the treatment, Phase II will then determine the effectiveness and side effects of the treatment. Phase III sees the expansion of the trial to a larger participant cohort and will compare the new treatment to existing treatments. A successful Phase III trial can lead to drug approval. Phase IV will monitor the long- term effects of the approved treatment.

Those taking part in clinical trials are called trial participants and they are volunteers who may be healthy or have a specific illness or condition.

Amplia is currently involved in clinical trials to develop new treatments for people with pancreatic and ovarian cancer.

The FDA has cleared Amplia's Investigational New Drug (IND) application to allow for a clinical trial in pancreatic cancer in the US with narmafotinib used in combination with the chemotherapy Folfirinox.

The trial is underway at sites in Melbourne and Sydney, Australia and will shortly open at selected sites in the US.

Orphan Drug Designation and Fast Track Designation has been granted to narmafotinib in pancreatic cancer in the US.

Our pre-clinical data demonstrates the potential of narmafotinib in the treatment of ovarian cancer. We are continuing to explore options for initiating a trial in ovarian cancer and, subject to funding, plan to commence recruitment in late 2025/early 2026.

Amplia's Compassionate Use Policy