Amplia Therapeutics Ltd (ASX:ATX) has received Human Research Ethics Committee (HREC) approval to start a Phase 2 clinical trial of its Focal Adhesion Kinase (FAK) inhibitor, AMP945, in first-line patients with advanced pancreatic cancer.
FAK plays a significant role in several chronic diseases, such as idiopathic pulmonary fibrosis (IPF), and ATX is advancing a pipeline of FAK inhibitors for cancer and fibrosis, with a particular focus in pancreatic and ovarian cancer.
With HREC approval, the company can focus on starting its recruitment process in the coming weeks, with the first patient expected to be dosed during April or May 2022.
The HREC approval allows the study to begin at sites in NSW, while a second application for HREC approval which will cover Victorian sites, has been submitted, with ATX expecting a final response shortly.
Two-part trial
The open-label single-arm Phase 2 clinical trial has two parts.
The first part is designed to identify the optimal dose of AMP945 in approximately 12 patients. First-line patients with advanced pancreatic cancer will be treated with a range of doses of AMP945. They will also be dosed with clinically established, current standard-of-care combination therapy consisting of gemcitabine and nab-paclitaxel.
Selection of the optimal dose will be based on safety, pharmacokinetic and pharmacodynamic measures and will be overseen by a Data Monitoring Committee.
Following this, ATX will treat approximately 26 first-line patients with the optimised dose of AMP945 in combination with gemcitabine and nab-paclitaxel.
Data from the trial will be used to conduct an interim analysis around mid-2023.
The primary endpoint of the trial will be patients’ Objective Response (OR) as measured using standardised RECIST criteria.
Cleared for take-off
“Today is a very exciting day for Amplia and we welcome the HREC’s clearance to commence the first clinical trial of AMP945 in pancreatic cancer patients,” Amplia’s CEO and managing director Dr John Lambert said.
“Given the challenges that have historically been faced in the clinic by new treatments for this devastating disease, we believe that the best opportunity to improve treatment outcomes is to enhance the efficacy of current standards of care.
"The preclinical data that we have generated to date has consistently indicated that AMP945 may be able to significantly improve the effectiveness of standard gemcitabine/nab-paclitaxel combination therapy.
“It’s a great tribute to our shareholders, the Amplia team, the original researchers and our Garvan collaborators that we are able to initiate this very important clinical trial and we are excited to see the results as they emerge.”