Posted: 7 July 2025
Amplia Therapeutics announced that dosing had been completed for the first group of patients in its ACCENT Phase 2 clinical study evaluating AMP945 combined with gemcitabine and nab-paclitaxel in advanced pancreatic cancer.
The ACCENT study, which had been conducted across multiple Australian clinical centres, had been designed to assess safety, tolerability, and preliminary efficacy of AMP945, a focal adhesion kinase (FAK) inhibitor, administered alongside standard chemotherapy in individuals with metastatic pancreatic ductal adenocarcinoma.
It was stated by Chief Medical Officer Dr Mark Devlin that the treatment had been well tolerated within the first cohort, and no dose-limiting toxicities had been observed. “The completion of Cohort 1 without any significant safety concerns has enabled the trial to progress as planned to the second cohort, where a higher dose of AMP945 will be administered,” Dr Devlin had said.
The study had utilised a dose-escalation design to determine the recommended dose of AMP945 for the planned Phase 2b expansion stage. Recruitment for the second cohort had already commenced following the independent safety committee’s approval to proceed.
Chief Executive Officer Dr Chris Burns had commented that this milestone was an important step forward for the programme. “We are encouraged by the safety data emerging from the trial and look forward to exploring the potential of AMP945 to enhance chemotherapy efficacy in this very challenging disease,” Dr Burns had stated.
Pancreatic cancer remains one of the most lethal cancers globally, and Amplia Therapeutics’ FAK inhibition strategy had been aimed at targeting the tumour microenvironment to improve patient outcomes.
The ACCENT trial had been partially funded by the Australian Government’s R&D Tax Incentive programme. Results from further cohorts were expected to inform Amplia’s clinical development pathway for AMP945 in oncology.
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