Australian pharmaceutical company Amplia Therapeutics (ASX: ATX) has completed the design for a phase 2 clinical trial of its focal adhesion kinase (FAK) inhibitor AMP945 for the treatment of advanced pancreatic cancer.
The design is based on studies conducted at Sydney’s Garvan Institute of Medical Research in animal models of pancreatic cancer, which have shown intermittent dosing of AMP945 can make tumours more responsive to standard chemotherapy treatments.
The primary endpoint will be based on the objective response rate from treatment compared to historical controls.
Multiple other signals of efficacy will be assessed in secondary and exploratory endpoints including duration of response, disease progression rates, survival and effects on biomarkers of disease.
Amplia’s trial (designated AMP945-202) will recruit newly-diagnosed Australian patients receiving first-line therapy and will be conducted as an open-label single arm exercise over two stages.
In the first stage, an optimal dose of AMP945 will be selected and a preliminary assessment of efficacy will be performed in approximately 40 patients.
In the second stage, up to 24 additional patients will be recruited to increase confidence in the preliminary results.
AMP945 will be administered orally to patients prior to each dose of standard of care chemotherapy for advanced pancreatic cancer using a combination of gemcitabine plus nab-paclitaxel.
All patients are expected to receive multiple rounds of treatment.
Amplia chief executive officer Dr John Lambert said the use of first-line patients is expected to expedite recruitment and provides the best opportunity to detect any efficacy signal from the addition of AMP945 to chemotherapy.
“Clinical evaluation of AMP945 as part of a first-line treatment for pancreatic cancer significantly de-risks our program and makes the drug relevant for a much larger patient base,” he said.
“The ability to test AMP945 in this setting has been made possible by the excellent safety and tolerability profile demonstrated in our recent phase 1 clinical trial.”
Pancreatic cancer affects approximately 60,000 people in the US and nearly 4,000 people in Australia each year.
It is believed to be one of the most deadly forms of cancer and the subtlety of symptoms means diagnosis is often not achieved until it has spread beyond the original site.
Currently the only potential cure available for pancreatic cancer is surgical excision; however, only around 20% of patients are eligible for surgery with the remainder having either localised, non-resectable (cannot be surgically removed) or metastatic disease.
For these patients, the standard first-line treatment is chemotherapy and less than 50% will go on to receive a second line therapy, for which there is no standard treatment.
“Patients with advanced pancreatic cancer have very limited treatment options and there is an unmet need for new therapies with novel mechanisms of action,” Dr Lambert said.
“If we are able to see positive signs that AMP945 improves the leading current treatment option, we will commence discussions with regulators and potential partners concerning future trials required to support product approval.”