Cohort 9 for Glioblastoma Multiforme (GBM)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Glioblastoma Multiforme (GBM)SONALA-001 (ALA) and Exablate device - CombinationProduct
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new cancer treatment called sonodynamic therapy (SDT) to see if it is safe and effective in people with brain tumors.

Eligible Conditions
  • Glioblastoma Multiforme (GBM)

Treatment Effectiveness

Study Objectives

4 Primary · 22 Secondary · Reporting Duration: 12 Months

12 Months
Progression-free survival rate at 12 Months
6 Months
Progression-free survival rate at 6 Months (Dose escalation only)
Progression-free survival rate at 6 Months (Expansion Cohort only)
Month 12
Objective Response (mRANO)
Month 12
Clinical benefit rate (CBR: CR, PR, and SD)
Duration of clinical benefit
Duration of response
Overall survival
Progression-free survival
Safety of ALA SDT
Time to response (TTR)
Day 1
Area under the plasma concentration vs time from Time 0 to infinity (AUC0-∞) of ALA in blood plasma
Area under the plasma concentration vs time from Time 0 to infinity (AUC0-∞) of PpIX in blood plasma
Area under the plasma concentration vs time from Time 0 to the last measurable timepoint (AUC0-t) of ALA in blood plasma
Area under the plasma concentration vs time from Time 0 to the last measurable timepoint (AUC0-t) of PpIX in blood plasma
Clearance of ALA in blood plasma
Clearance of PpIX in blood plasma
Elimination rate constant of ALA in blood plasma
Elimination rate constant of PpIX in blood plasma
Terminal elimination half-life (t1/2) of ALA in blood plasma
Terminal elimination half-life (t1/2) of PpIX in blood plasma
Time to maximum drug concentration (Tmax) of ALA in blood plasma
Time to maximum drug concentration (Tmax) of PpIX in blood plasma
Volume of distribution as steady state (Vss)
Day 29
MTD
Day 29
Determination of Recommended Phase 2 Schedule

Trial Safety

Trial Design

9 Treatment Groups

Cohort 9
1 of 9
Cohort 2
1 of 9
Cohort 8
1 of 9
Cohort 6
1 of 9
Cohort 7
1 of 9
Cohort 1
1 of 9
Cohort 3
1 of 9
Cohort 5
1 of 9
Cohort 4
1 of 9

Experimental Treatment

50 Total Participants · 9 Treatment Groups

Primary Treatment: Cohort 9 · No Placebo Group · Phase 1 & 2

Cohort 9
CombinationProduct
Experimental Group · 1 Intervention: SONALA-001 (ALA) and Exablate device · Intervention Types: CombinationProduct
Cohort 2
CombinationProduct
Experimental Group · 1 Intervention: SONALA-001 (ALA) and Exablate device · Intervention Types: CombinationProduct
Cohort 8
CombinationProduct
Experimental Group · 1 Intervention: SONALA-001 (ALA) and Exablate device · Intervention Types: CombinationProduct
Cohort 6
CombinationProduct
Experimental Group · 1 Intervention: SONALA-001 (ALA) and Exablate device · Intervention Types: CombinationProduct
Cohort 7
CombinationProduct
Experimental Group · 1 Intervention: SONALA-001 (ALA) and Exablate device · Intervention Types: CombinationProduct
Cohort 1
CombinationProduct
Experimental Group · 1 Intervention: SONALA-001 (ALA) and Exablate device · Intervention Types: CombinationProduct
Cohort 3
CombinationProduct
Experimental Group · 1 Intervention: SONALA-001 (ALA) and Exablate device · Intervention Types: CombinationProduct
Cohort 5
CombinationProduct
Experimental Group · 1 Intervention: SONALA-001 (ALA) and Exablate device · Intervention Types: CombinationProduct
Cohort 4
CombinationProduct
Experimental Group · 1 Intervention: SONALA-001 (ALA) and Exablate device · Intervention Types: CombinationProduct

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months

Who is running the clinical trial?

SonALAsense, Inc.Lead Sponsor
2 Previous Clinical Trials
48 Total Patients Enrolled
Stuart Marcus, MD, PhDPrincipal InvestigatorSonALAsense, Inc.
9 Previous Clinical Trials
1,126 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are 18 years or older.
You have primary (de novo) glioblastoma multiforme (GBM) that has recurred or progressed (first or second recurrence, including this recurrence) and resection not indicated.
You have a single supratentorial, contrast-enhancing, and bi-dimensionally measurable tumor that is 5 mL to 30 mL in volume, based on MRI within 14 days prior to Day 1.
You have a tumor that is not resectable, metastatic, or has a history of prior radiotherapy and temozolomide
You have no recurrence within 12 weeks of completion of radiotherapy.