Window of Opportunity Study of DSP-0390 in Gliomas

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT06636162
Phase
EARLY_PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Glioma, Malignant
  • IDH Mutation

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • DSP-0390 — DRUG
    DSP-0390 will be administered orally with preferably 200 mL of water, or approximately one-half cup water. The patient will take DSP-0390 after a minimum of a 6-hour fast and will fast for 1 hour after taking the dose.

Study Details

This study focuses on determining the pharmacokinetic and pharmacodynamic effect of DSP-0390 in brain and blood from patients with IDH-mutant 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.

Key Dates

Start date
Apr 3, 2025
Status verified
Apr 2026
Primary completion
Apr 17, 2027
Completion
May 17, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A Low Grade Gliomas: DSP-0390 120 mg
    Patients will be assigned to DSP-0390 120 mg once daily by mouth for approximately 2 weeks and up to 17 days prior to surgical resection, with the final dose being administered the morning of surgery.
  • Experimental: Arm B High Grade Gliomas: DSP-0390 180 mg
    Patients will be assigned to DSP-0390 180 mg once daily by mouth for approximately 1 week prior to surgical resection, with the final dose being administered the morning of surgery.

Primary Outcome Measure

Unbound DSP-0390 concentration in non-enhancing tumor tissue [ Time Frame: At time of surgery following treatment (estimated to be 2 weeks) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110
Omar H Butt, M.D., Ph.D.
[email protected]
314-747-4241
Omar H Butt, M.D., Ph.D. (PRINCIPAL_INVESTIGATOR)
Ryan Cleary, M.D. (SUB_INVESTIGATOR)
Albert H Kim, M.D., Ph.D. (SUB_INVESTIGATOR)
Jingqin (Rosy) Luo, Ph.D. (SUB_INVESTIGATOR)

Find similar trials in St Louis, MO

By research site
Washington University School of Medicine· St Louis, MO

Related Studies