MedTrace Logo

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

NCT05370508 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2024-07-26

No results posted yet for this study

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.

Conditions

  • Recurrent GBM

Interventions

COMBINATION_PRODUCT

SONALA-001 (ALA) and MR-Guided Focused Ultrasound device (MRgFUS)

SONALA-001(ALA) given 6-12 hours prior to receiving the MRgFUS

Sponsors & Collaborators

  • SonALAsense, Inc.

    lead INDUSTRY

Principal Investigators

  • Corina Andresen, MD · SonALAsense, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-06
Primary Completion
2024-06-11
Completion
2024-07-08
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05370508 on ClinicalTrials.gov