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

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

Timeline

Start

2022-08-12

Primary completion

2024-07-30

Completion

2024-10-30

Outcome

Outcome not reported

Stopped (Business): “The study is suspended due to lack of funding but not due to safety concerns.”

Drugs

Indications