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Phase 2 pivotal registrational study of BCB-276

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Trial Profile

Phase 2 pivotal registrational study of BCB-276

Status: Planning
Phase of Trial: Phase II

Latest Information Update: 14 Jan 2025

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At a glance

  • Drugs BCB 276 (Primary)
  • Indications Diffuse intrinsic pontine glioma
  • Focus Registrational; Therapeutic Use
  • Most Recent Events

    • 14 Jan 2025 New trial record
    • 07 Jan 2025 According to BrainChild Bio media release, company look forward to the initiation of the BCB-276 pivotal trial by the end of 2025.
    • 07 Jan 2025 According to BrainChild Bio media release, company plans to advance BCB-276 in a single pivotal registration trial designed to accelerate the path to submit a Biologics License Application for the treatment of children and young adults with DIPG. This clinical plan is based on alignment with the FDA at a Type B meeting. This potentially accelerated clinical path for BCB-276 is supported by the preliminary data for BCB-276 from a Phase 1 clinical trial conducted by Seattle Children.

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