NCT05123534

A Phase 2 Study of Sonodynamic Therapy Using SONALA-001 and Exablate 4000 Type 2.0 in Patients with DIPG

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: Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: SonALAsense, Inc. · Industry
• Sex: All
• Age: 5 Years
• Healthy volunteers: Not accepted

Summary

The primary objectives of this trial are to evaluate the safety and tolerability of sonodynamic therapy (SDT) using SONALA-001 and Exablate Type 2.0 device and to determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of MR-Guided Focused Ultrasound (MRgFUS) energy in combination with SONALA-001 in subjects with diffuse intrinsic pontine glioma Funding Source - FDA OOPD

Conditions

• Diffuse Intrinsic Pontine Glioma
• Diffuse Midline Glioma

Interventions

Type	Name	Description
COMBINATION_PRODUCT	SONALA-001 (ALA) and MR-Guided Focused Ultrasound device (MRgFUS)	SONALA-001(ALA) given 6-12 hours prior to receiving the MRgFUS.

Timeline

• Start date: 2022-08-12
• Primary completion: 2024-07-30
• Completion: 2024-10-30
• First posted: 2021-11-17
• Last updated: 2024-09-19

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study