A 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)
Latest Information Update: 05 Jul 2024
At a glance
- Drugs Aminolevulinic acid (Primary)
- Indications Diffuse intrinsic pontine glioma
- Focus Adverse reactions; First in man; Proof of concept
- Sponsors SonALAsense
- 04 Jun 2024 Interim Results(n=6 , between August 2022 and December 2023) studing sonodynamic therapy (SDT) using SONALA-001 together with MR-guided low-intensity focused ultrasound , presented at the 60th Annual Meeting of the American Society of Clinical Oncology
- 14 Feb 2024 Planned number of patients changed from 37 to 40.
- 29 Jan 2024 phase changed from 1\2 to 2,no arms change from 3 to 5,planned patient no changed from 27 to 37,addition of DMG group to treatment and patient inclusion criteria .