On April 19, 2023 Amplia Therapeutics reported that dosing of the first patient in Cohort 3 of the Company’s ongoing Phase 1b/2a ACCENT clinical trial of FAK inhibitor AMP945 in pancreatic cancer has begun (Press release, Amplia Therapeutics, APR 19, 2023, View Source;[email protected] [SID1234630265]).
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Cohort 3 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 2 was safe and well-tolerated. In the ACCENT trial, AMP945 is dosed orally (as a capsule) in the lead-up to, and between, standardised weekly dosing of gemcitabine and nab-paclitaxel chemotherapy.
Amplia CEO and Managing Director, Dr Chris Burns, commented: "We are very pleased with the recent progress in the ACCENT trial and moving rapidly to Cohort 3 is the next step in identifying a safe and effective dose to take forward to the Phase 2 stage of the trial. We are extremely grateful to the clinical trial sites for their hard work in progressing the trial so quickly, and to the patients and their loved ones for agreeing 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 stage of the trial (Phase 1b) is an 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 in first-line patients with advanced pancreatic cancer.
The second stage of the trial (Phase 2a) is also a single-arm, open-label study and is designed to determine the impact of AMP945 in combination with gemcitabine and nab-paclitaxel on patient outcomes. 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.