Amplia Therapeutics Limited announced that dosing of the first patient in Cohort 2 of the Company's ongoing Phase 1b/2a ACCENT clinical trial of focal adhesion kinase (FAK) inhibitor AMP945 has begun. Cohort 2 will consist of three patients receiving an increased dose of AMP945 after the safety committee's recent assessment that the AMP945 dose used in Cohort 1 was safe and well-tolerated. The protocol for the ACCENT trial is entitled "A Phase 1b/2a, Multicentre, Open Label Study of the Pharmacokinetics, Safety and Efficacy of AMP945 in Combination with Nab-paclitaxel and Gemcitabine in Pancreatic Cancer Patients".

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. 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 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.