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A phase 2b/3 clinical trial assessing narmafotinib in pancreatic cancer

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Trial Profile

A phase 2b/3 clinical trial assessing narmafotinib in pancreatic cancer

Status: Planning
Phase of Trial: Phase II/III

Latest Information Update: 13 Feb 2026

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At a glance

  • Drugs Narmafotinib (Primary) ; Gemcitabine; Paclitaxel
  • Indications Pancreatic cancer
  • Focus Registrational; Therapeutic Use

Most Recent Events

  • 30 Jan 2026 According to an Amplia Therapeutics Limited media release, this quarter, the Company announced that it had received positive feedback from the US FDA supporting the dose optimisation strategy for narmafotinib in its planned registration enabling Phase 2b/3 trial in pancreatic cancer. Proposed amendments to the trial design are not expected to impact the overall development timeline.
  • 20 Nov 2025 According to an Amplia Therapeutics Limited media release, the company has received positive response from the USFDA during a Type D meeting regarding this planned phase 2b/3 study combining narmafotinib with gemcitabine and Abraxane for pancreatic cancer. The FDA supports the two-dose comparison envisaged in the Phase 2b study, leading into the pivotal Phase 3 stage of the trial, and the minor changes proposed will have minimal effect on the planned timeline.
  • 20 Nov 2025 According to an Amplia Therapeutics Limited media release, the trial protocol will be prepared for FDA review in H1 2026, while the company aims to start this registration-enabling study in late 2026.

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