Window of Opportunity Study of DSP-0390 in Gliomas

Early Phase 1

Recruiting

• Conditions: Glioma, Malignant; Grade II Glioma; IDH Mutation
• Interventions: Drug: DSP-0390

• Registration Number: NCT06636162
• Lead Sponsor: Washington University School of Medicine

Brief Summary

This study focuses on determining the pharmacokinetic and pharmacodynamic effect of DSP-0390 in brain and blood from patients with IDH-mutant WHO grade II or III glioma undergoing tumor resection. Tissue will be collected during surgical resection. Blood will be drawn at various time points throughout the 2 weeks of treatment. The hypothesis is that DSP-0390 will accumulate in brain tumor tissue at pharmacologically relevant concentrations, and that alterations in cholesterol metabolism driven by mutant IDH will increase susceptibility to DSP-0390 and lead to tumor cell death.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-08
• Study First Submitted QC: 2024-10-08
• Study First Posted: 2024-10-10
• Status Verified: 2025-04
• Study Start: 2025-04-03
• Last Update Submitted: 2025-04-04
• Last Update Posted: 2025-04-06
• Primary Completion: 2026-04-17
• Study Completion: 2026-05-17

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
DSP-0390 240 mg	DSP-0390	The next 10 patients will be assigned to DSP-0390 240 mg once daily by mouth for 2 weeks prior to surgical resection, with the final dose being administered the morning of surgery.
DSP-0390 120 mg	DSP-0390	The first 10 patients will be assigned to DSP-0390 120 mg once daily by mouth for 2 weeks prior to surgical resection, with the final dose being administered the morning of surgery.

Primary Outcome Measures

Name	Time	Method
Unbound DSP-0390 concentration in non-enhancing tumor tissue	At time of surgery following treatment (estimated to be 2 weeks)	Unbound DSP-0390 concentration in non-enhancing tumor tissue will be quantified using tissue removed during resection after treatment.
Changes in DSP-0390 concentration in plasma	From start of treatment through end of treatment (estimated to be 2 weeks)	Unbound DSP-0390 concentration in plasma will be quantified using blood samples taken throughout treatment.

Secondary Outcome Measures

Name	Time	Method
Incidence of treatment emergent adverse events (TEAEs)	From start of treatment through 30 day follow-up (estimated to be 6 weeks)	Assessed using CTCAE v5.0
Incidence of grade 3 or higher study drug related adverse events (AEs)	From start of treatment through 30 day follow-up (estimated to be 6 weeks)	Assessed using CTCAE v5.0
Lathosterol levels in non-enhancing tumor tissue	At time of surgery following treatment (estimated to be 2 weeks)	Lathosterol levels in non-enhancing tumor tissue will be quantified using tissue removed during resection after treatment.
Changes in lathosterol levels in non-enhancing tumor tissue	Baseline and at time of surgery following treatment (estimated to be 2 weeks)	Lathosterol levels in non-enhancing tumor tissue will be quantified using tissue removed during resection after treatment.
Zymostenol levels in non-enhancing tumor tissue	At time of surgery following treatment (estimated to be 2 weeks)	Zymostenol levels in non-enhancing tumor tissue will be quantified using tissue removed during resection after treatment.
Changes in zymostenol levels in non-enhancing tumor tissue	Baseline and at time of surgery following treatment (estimated to be 2 weeks)	Zymostenol levels in non-enhancing tumor tissue will be quantified using tissue removed during resection after treatment.
Lathosterol/zymostenol (L/Z) ratio in non-enhancing tumor tissue	At time of surgery following treatment (estimated to be 2 weeks)	L/Z ratio in non-enhancing tumor tissue will be quantified using tissue removed during resection after treatment.
Changes in lathosterol/zymostenol (L/Z) ratio in non-enhancing tumor tissue	Baseline and at time of surgery following treatment (estimated to be 2 weeks)	L/Z ratio in non-enhancing tumor tissue will be quantified using tissue removed during resection after treatment.
Changes in lathosterol levels in blood	From start of treatment through day 16	Change in lathosterol levels in blood will be quantified after surgical resection.
Changes in zymostenol levels in blood	From start of treatment through day 16	Change in zymostenol levels in blood will be quantified after surgical resection.
Changes in L/Z ratio in blood	From start of treatment through day 16	Change in L/Z ratio in blood will be quantified after surgical resection.

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States