Amplia initiates Phase 2b pancreatic cancer trial

Amplia Therapeutics (ASX:ATX) initiated the first stage of a registration-enabling Phase 2b clinical trial for its drug candidate, narmafotinib.

The new study is designed to evaluate a novel daily dosing regimen of the best-in-class focal adhesion kinase inhibitor, which has already received both orphan drug and fast track designations from the US FDA for the treatment of advanced pancreatic cancer.

Building upon compelling data from the previous Phase 1b/2a ACCENT study, this phase will investigate narmafotinib at two distinct daily dosing levels.

The drug will be administered in combination with the standard chemotherapy regimen of gemcitabine and Abraxane for newly diagnosed patients.

Historically, narmafotinib was given on an intermittent schedule, demonstrating encouraging efficacy signals without adding any significant tolerability burden beyond chemotherapy alone.

Amplia’s leadership believes transitioning to daily dosing will further unlock the drug's therapeutic potential.

The initial stage of the trial will enrol 12 patients across three to four clinical sites in Australia, split equally into two cohorts.

Beyond primary assessments of safety, tolerability, and pharmacokinetics, the trial will explore critical biomarkers and effects on tissue fibrosis—a major indicator of FAK activity.

Amplia accelerated the launch of this study by redeploying clinic-ready drug products and clinical resources following the conclusion of its AMPLICITY trial.

Patient enrolment is slated to commence by the fourth quarter of this year, with initial safety and pharmacokinetic assessments projected for completion by the second quarter of 2027.