Amplia Therapeutics Ltd (ASX:ATX) has recruited the first patient for its phase 1b/2a ACCENT clinical trial of focal adhesion kinase (FAK) inhibitor AMP945 for the treatment of patients with advanced pancreatic cancer.
AMP945 targets FAK and its use in the ACCENT trial is intended to enhance the efficacy of gemcitabine/nab-paclitaxel chemotherapy for people with advanced pancreatic cancer undergoing first-line treatment.
Patients in the trial will receive AMP945 in addition to a standard treatment regimen with gemcitabine/nab-paclitaxel.
“Exciting milestone”
Amplia CEO and managing director Dr John Lambert “This is another exciting milestone marking the achievements and growth of our company and we’re very proud of our team’s efforts in starting up the ACCENT trial.
“The work we have done to date with AMP945 both in the clinic and in preclinical models of pancreatic cancer tells us that AMP945 deserves to be clinically tested in this dangerous type of cancer
“We are also grateful to our first patient and their family for consenting to join the trial.
“It is our sincere hope that addition of AMP945 to a standard of care in pancreatic cancer improves outcomes for all patients.”
ACCENT Trial
The trial is to be conducted in two stages, the first, Phase 1b stage of the trial, is a single-arm open-label study to select an optimal dose of AMP945 by assessing the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of AMP945 when dosed in combination with gemcitabine and nab-paclitaxel (Abraxane®) in first-line patients with advanced pancreatic cancer.
About, 12 patients will be recruited across 4-5 sites in Australia where ascending oral doses of AMP945 will be given together with a fixed dose combination of gemcitabine and nab-paclitaxel.
The second, Phase 2a, stage of the trial is also a single-arm open-label study and is designed to perform an assessment of the optimal dose of AMP945 (selected in the phase 1b part of the trial) in combination with gemcitabine and nab-paclitaxel
The primary endpoint of the Phase 2a trial is the objective response rate (ORR) of patients to treatment.
Further endpoints will assess efficacy by other means as well as safety and tolerability.