Amplia Therapeutics Enrolls First 26 Subjects for Phase IIa ACCENT Trial

Amplia Therapeutics Enrolls First 26 Subjects for Phase IIa ACCENT Trial

Luisa Hernandez
2 min read

Amplia Therapeutics Advances Phase IIa Trial for Narmafotinib in Pancreatic Cancer Treatment

Amplia Therapeutics has made substantial progress in its clinical trial for narmafotinib, an innovative treatment for advanced pancreatic cancer. The company has successfully enrolled 26 subjects for the Phase IIa trial, following the completion of a Phase Ib study which established the safety and tolerability of a 400mg daily oral dose of narmafotinib. The trial utilizes Simon’s Two-Stage Trial design and will conduct an interim analysis after evaluating responses from the initial 26 patients. Should the analysis reveal positive responses from six or more patients, the trial will be expanded to include an additional 24 participants, totaling 50 patients. Dr. Chris Burns, CEO of Amplia, has expressed optimism about the trial's progress and anticipates interim results by early Q4 2024. Furthermore, Amplia has received FDA approval to commence a new clinical trial combining narmafotinib with the chemotherapy regimen FOLFIRINOX, aiming to improve treatment options for pancreatic cancer.

Key Takeaways

  • Amplia Therapeutics initiates Phase IIa trial with 26 patients for narmafotinib in advanced pancreatic cancer.
  • The Phase IIa trial follows a successful Phase Ib trial that confirmed the safety and tolerability of a 400mg daily dose.
  • An interim analysis is planned after the initial responses from the 26 patients to determine potential trial expansion.
  • The trial will expand to include 50 patients if six or more show partial or complete responses.
  • Amplia aims to report interim analysis results by early Q4 2024.


Amplia Therapeutics' Phase IIa trial for narmafotinib in pancreatic cancer could have significant implications for stakeholders, including investors and healthcare providers. Success in the trial may boost Amplia's stock and attract additional funding, while also providing a potential new treatment option for patients. The interim analysis, crucial for the trial's continuation, will guide future drug development and market positioning. Long-term positive outcomes could reshape pancreatic cancer therapy, impacting pharmaceutical competition and patient outcomes.

Did You Know?

  • Amplia Therapeutics:
    • Amplia Therapeutics is a biopharmaceutical company dedicated to developing innovative therapeutics for various cancers. They are currently conducting clinical trials for narmafotinib, a drug designed to treat advanced pancreatic cancer.
  • Narmafotinib:
    • Narmafotinib is a novel drug under development by Amplia Therapeutics for evaluating its effectiveness and safety in treating advanced pancreatic cancer. The drug has successfully completed a Phase Ib trial, establishing a safe daily oral dose of 400mg.
  • Simon’s Two-Stage Trial Design:
    • Simon’s Two-Stage Trial design is a statistical method utilized in clinical trials, especially in phase II trials, to efficiently assess the efficacy of a new treatment. The trial is conducted in two stages: the first stage evaluates a small number of patients, and if a predetermined level of efficacy is met, the trial proceeds to the second stage with a larger patient population. This design aids in efficiently allocating resources and determining the potential benefits of a new treatment.

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