Posted: 7 August 2023
Amplia Therapeutics Limited (ASX: ATX), (“Amplia” or the “Company”), is pleased to provide an update on progress in the ongoing Phase 1b/2a ACCENT clinical trial in first-line patients with advanced pancreatic cancer.
The current Phase 1b stage of the ACCENT trial is designed to test ascending doses of AMP945 in patients, given in combination with gemcitabine and nab-paclitaxel. The dose-escalation stage will cease, and a recommended dose for the Phase 2a stage of the trial identified, when either two or more dose-limiting toxicities (DLTs) are observed and/or when the pharmacokinetic and pharmacodynamic profiles are predicted to be optimised.
We are currently dosing the third cohort of patients in the dose-escalation phase of the trial. At this time 12 patients have been dosed across the 3 cohorts and have completed their first full cycle of treatment (28 days). Notably all patients, in consultation with their physicians, elected to stay on the study drug after completion of the first cycle of treatment. A DLT signal was reported in one patient in the current cohort, and consistent with the trial protocol, we expanded this third cohort with an additional three patients. We are now pleased to report the final patient in this cohort has been recruited and began dosing yesterday. Importantly, all other patients in this cohort have completed their first full 28-day cycle and continue to remain on drug at this dose. In line with the study protocol, we will continue to collect the data for this expanded cohort to determine whether further doseescalation is warranted. The combined data will be reviewed by the Safety Committee once all patients in this cohort have been dosed for a complete 28-day cycle.
Amplia’s CEO and Managing Director Dr Chris Burns commented: “While the cohort expansion has resulted in a delay for the complete data from this cohort to be reviewed by the safety committee, we continue to be encouraged by the data reported from all trial sites. We are grateful for the patients who are participating in the trial, and I look forward to reporting the outcomes from the Safety Committee meeting next month.”
