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A Phase 2 Dose-escalation Study Examining the Safety, Pharmacokinetics, and Preliminary Efficacy of Ascending Drug and Energy Dose Combinations for Sonodynamic Therapy Using SONALA-001 in Combination with Exablate 4000 Type 2.0 MR-Guided Focused Ultrasound in Subjects with Diffuse Intrinsic Pontine Glioma (DIPG) and Diffuse Midline Glioma (DMG)

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Trial Profile

A Phase 2 Dose-escalation Study Examining the Safety, Pharmacokinetics, and Preliminary Efficacy of Ascending Drug and Energy Dose Combinations for Sonodynamic Therapy Using SONALA-001 in Combination with Exablate 4000 Type 2.0 MR-Guided Focused Ultrasound in Subjects with Diffuse Intrinsic Pontine Glioma (DIPG) and Diffuse Midline Glioma (DMG)

Status: Suspended
Phase of Trial: Phase II

Latest Information Update: 26 Sep 2024

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At a glance

  • Drugs Aminolevulinic acid (Primary)
  • Indications Diffuse intrinsic pontine glioma
  • Focus Adverse reactions; First in man; Proof of concept
  • Sponsors SonALAsense

    • Most Recent Events

    • 10 Sep 2024 Planned End Date changed from 12 Aug 2025 to 30 Oct 2024.
    • 10 Sep 2024 Status changed from discontinued to suspended.
    • 02 Aug 2024 Status changed from active, no longer recruiting to discontinued due to lack of funding.

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