Posted: 12 April 2023
Amplia Therapeutics Limited is pleased to advise that following a review of safety data collected to date, the ACCENT clinical trial’s Safety Review Committee has approved dose escalation of AMP945 and recruitment of a third patient cohort.
The ACCENT trial explores whether addition of Amplia’s FAK inhibitor AMP945 to standard of care chemotherapy of gemcitabine/nab-paclitaxel in first-line pancreatic cancer patients improves patient outcomes in this devastating disease. The first stage of the trial is designed to identify the most suitable dose of AMP945 to combine with gemcitabine/nab-paclitaxel and thus ascending doses of AMP945 are given in combination with the chemotherapy while safety, pharmacokinetics and pharmacodynamics are monitored. Dose escalation of AMP945 will continue until either a doselimiting safety signal is identified or the pharmacodynamic effect of AMP945 reaches a plateau.
The second patient cohort in the ACCENT trial was recruited over one month in February 2023, and drug safety and tolerability was monitored for a minimum of one treatment cycle (28 days). The ACCENT trial’s Safety Review Committee has now examined the available safety, pharmacokinetic and pharmacodynamic data and concluded that dose escalation to a further cohort is warranted.
Amplia’s CEO and Managing Director Dr Chris Burns commented: “We are very pleased that the data collected from the trial to date supports further dose escalation to a third cohort of patients. The data is tracking as predicted from our previous Phase 1 healthy volunteer study and with preclinical models, and we believe we are closing in on a dose to take forward into stage 2 of the ACCENT trial.”
