Amplia Therapeutics (ASX:ATX) has announced the completion of enrolment of the third cohort of patients in the ongoing Phase 1b/2a ACCENT clinical trial in frontline patients with pancreatic cancer.
CEO and managing director Dr Chris Burns said, “We are very pleased to have completed recruitment of Cohort 3, despite the disruption of holidays in April. This achievement reflects the enthusiasm and commitment of the clinical trial sites in Melbourne, Sydney and Brisbane which has allowed recruitment for this cohort to be completed within one month of opening enrolment. As always, we thank the patients for consenting to be part of the trial.”
The company said the first stage of the ACCENT trial is designed to test ascending doses of AMP945 given in combination with standard-of-care chemotherapy of gemcitabine and nab-paclitaxel, in patients with advanced pancreatic cancer.
The trial will be conducted in two stages.
The first, Phase 1b stage of the trial, is a single-arm 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, Phase 2a, stage of the trial is also a single-arm open-label study. It is designed to assess the optimal dose of AMP945, in combination with gemcitabine and nabpaclitaxel, with the primary endpoint being Objective Response Rate (ORR).