Cohort 9 for Glioblastoma Multiforme (GBM)

Phase-Based Progress Estimates

Effectiveness

Safety

Glioblastoma Multiforme (GBM)SONALA-001 (ALA) and Exablate device - CombinationProduct

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Eligibility

18+

All Sexes

What conditions do you have?

Select

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

Effectiveness Progress

1 of 3

DSP-0390

CV01-delivered ultrasound

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

Safety Progress

1 of 3

DSP-0390

CV01-delivered ultrasound

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