On January 31, 2023 Amplia Therapeutics Limited (ASX: ATX) (Amplia or the Company) reported the dosing of 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 (Press release, Amplia Therapeutics, FEB 1, 2023, View Source;[email protected] [SID1234626679]).
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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. Amplia CEO and Managing Director, Dr Chris Burns, commented: "Identifying a safe and welltolerated dose of AMP945 that effectively shuts down FAK activity is a critical part of the Phase 1b arm of the ACCENT trial. Based on our extensive preclinical studies, we are hopeful that AMP945 used in conjunction with standard-of-care drugs gemcitabine/nab-paclitaxel, will improve patient outcomes. As always, we are grateful to the patients and their loved ones for consenting to take part in this trial."
About the ACCENT Trial
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 nabpaclitaxel. 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 our website and at ClinicalTrials.gov under the identifier NCT05355298. The Company will provide further updates on the trial as recruitment proceeds.
This ASX announcement was approved and authorised for release by the Board of Amplia Therapeutics.