Phase 1/2 DIPG
(SDT-201)
SonALAsense is conducting an ascending energy and drug dose-escalation study examining the safety, pharmacokinetics, and preliminary efficacy of sonodynamic therapy using SONALA-001 in combination with the Exablate 4000 Type-2 MR-Guided Focused Ultrasound device to treat patients diagnosed with DIPG.
Phase 1/2 DIPG Clinical Trial Design
This trial will be conducted using a special form of statistical analysis that allows a rapid drug dose and energy dose escalation while maintaining maximum safety standards. The trial will be a drug dose + focused ultrasound energy escalation study, where patients will be treated with 5, 10 or 15 mg/kg of SONALA-001 in combination with either 200, 400 or 800J of focused ultrasound.
The study will enroll 18-24 subjects in up to 9 cohorts of approximately 3 subjects each.
For more details visit our ClinicalTrials.gov listing: