Amplia Therapeutics Limited announced completion of enrolment of the second cohort of patients in the ongoing Phase 1b/2a ACCENT clinical trial in frontline patients with pancreatic cancer. The first stage of the ACCENT trial is designed to test ascending doses of AMP945 given in combination with standard gemcitabine/nab-paclitaxel chemotherapy in patients with advanced pancreatic cancer. After 1 month of treatment, the trial's Safety Committee will review the clinical data collected and, subject to the data, authorise dose escalation of AMP945 in a subsequent cohort.

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.

More information about the ACCENT trial, including a list of participating sites, can be found via website and at ClinicalTrials.gov under the identifier NCT05355298. The Company will provide further updates on the trial as recruitment proceeds.