Amplia has announced that the final patient in an expanded third cohort of the current Phase 1b stage of the ACCENT trial has been recruited and began dosing yesterday.
At this time 12 patients have been dosed and all have elected to stay on the drug after completion of the first full cycle of treatment (28 days). The cohort has been expanded to include an additional three patients, and once all patients have completed their first full cycle of treatment, the combined data will be reviewed by the Safety Committee to determine whether further dose-escalation is warranted.
The first, Phase 1b stage of the trial will determine 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.
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, a valuable contribution to medical research, and I look forward to reporting the outcomes from the Safety Committee meeting next month.”
Click here to read today’s ASX release.