Amplia Therapeutics Ltd (ASX:ATX) has completed the design for a Phase 2 clinical trial of its Focal Adhesion Kinase (FAK) inhibitor, AMP945 in newly diagnosed patients receiving first-line therapy for pancreatic cancer.
The pharmaceutical company plans to initiate patient recruitment at Australian sites in the first quarter of 2022.
“Desperately need new therapies”
The trial’s lead investigator from Sydney’s Westmead Hospital, Dr Adnan Nagrial, said: “Patients with advanced pancreatic cancer have very limited treatment options and we desperately need new therapies with novel mechanisms of action.
“Based on the evidence we have seen so far, FAK inhibitors deserve to be tested in the clinic and I am excited to be part of this trial”.
Trial design
The Phase 2 trial of AMP945 will be an open-label single-arm trial conducted in two stages.
In the first stage, an optimal dose of AMP945 will be selected and a preliminary assessment of efficacy will be performed in around 40 pancreatic cancer patients.
In the second stage, up to an additional 24 pancreatic cancer patients will be recruited to increase confidence in the preliminary results.
All patients are expected to receive multiple rounds of treatment.
The Phase 2 clinical trial will add AMP945 to chemotherapy with gemcitabine and nabpaclitaxel, which is a standard of care currently used to treat the majority of newly diagnosed advanced pancreatic cancer patients.
In the trial, designated AMP945-202, AMP945 will be administered orally to patients prior to each dose of their standard gemcitabine/nab-paclitaxel chemotherapy.
The trial design is based on studies conducted in collaboration with Professor Paul Timpson’s group at the Garvan Institute of Medical Research, Sydney, where it has been shown that intermittent dosing of AMP945 makes tumours more responsive to standard chemotherapy treatments in animal models of pancreatic cancer.
Largest relevant patient population
Conducting the Phase 2 clinical trial in first-line patients is expected to expedite recruitment for the trial and provides the best opportunity to detect any efficacy signal from the addition of AMP945 to chemotherapy.
The ability to test AMP945 in a first-line setting is also made possible by the excellent safety and tolerability profile demonstrated in Amplia’s recent Phase 1 clinical trial.
Amplia expects recruitment will take 18-24 months but it is working with vendors to accelerate key aspects of the trial.
The primary endpoint for the trial will be based on the objective response rate from treatment compared to historical controls.
Further, multiple other signals of efficacy will be assessed in the trial’s secondary and exploratory endpoints including duration of response, disease progression rates, survival and effects on biomarkers of disease.