A Study of Sonodynamic Therapy Using SONALA-001 and Exablate 4000 Type 2.0 in Subjects With Recurrent GBM

Recurrent GBM Clinical Trial

Official title:
A Phase 1/2 Dose Escalation and Expansion Study of Sonodynamic Therapy With SONALA-001 in Combination With Exablate 4000 Type 2.0 MR-Guided Focused Ultrasound in Subjects With Progressive or Recurrent Glioblastoma Multiforme (rGBM)

Status Active, not recruiting

Clinical Trial Summary

The primary objectives of this trial are to evaluate the safety, dose-limiting toxicities, maximum tolerated dose (MTD), maximum administered dose (MAD) and recommended Phase 2 dose (RP2D) for future study after a single treatment of SONALA-001 in combination with MRgFUS and to evaluate preliminary efficacy of sonodynamic therapy (SDT) using SONALA-001 and Exablate Type 2.0 device in subjects with progressive or recurrent GBM.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05370508
Study type	Interventional
Source	SonALAsense, Inc.
Contact
Status	Active, not recruiting
Phase	Phase 1/Phase 2
Start date	February 6, 2023
Completion date	November 30, 2026

View Details

See also
Status	Clinical Trial	Phase
Terminated	`NCT04681677` - Recurrent GBM Treated With Neurosurgical Resection and IORT Using the Xoft Axxent eBx System and Bevacizumab	Phase 2
Terminated	`NCT04763031` - Recurrent GBM With Maximal Neurosurgical Removal and Treatment With IORT	N/A
No longer available	`NCT03068650` - Expanded Access (Compassionate Use) Treatment Protocol Rindopepimut	N/A