Posted: 23 January
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 another patient cohort.
The first stage of the ACCENT trial is designed to identify the most suitable dose of AMP945 to combine with gemcitabine/nab-paclitaxel chemotherapy in patients with advanced pancreatic cancer. Accordingly, ascending doses of AMP945 are given in combination with standard gemcitabine/nabpaclitaxel chemotherapy while safety, pharmacokinetics and pharmacodynamics are monitored. Dose escalation of AMP945 will continue until either a dose-limiting safety signal is identified or the pharmacodynamic effect of AMP945 reaches a plateau. The Company expects that up to four cohorts of three patients may be required to identify the most suitable dose of AMP945.
Following completion of recruitment of the first cohort in late 2022, 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.
