RecruitingEarly Phase 1NCT06636162

Window of Opportunity Study of DSP-0390 in Gliomas

Early Phase 1 Window of Opportunity Study of Oral DSP-0390 in Gliomas


Sponsor

Washington University School of Medicine

Enrollment

20 participants

Start Date

Apr 3, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new drug called DSP-0390 in people who have a type of brain tumor called a glioma — specifically lower-grade or recurring gliomas with a particular genetic change (IDH mutation). The drug is given before surgery so researchers can study how it affects tumor tissue. **You may be eligible if...** - You are 18 or older with a suspected or confirmed lower-grade or recurring IDH-mutant glioma - You are scheduled for brain surgery to remove or biopsy the tumor - Your blood counts, liver, and kidney function are within acceptable ranges - You are in generally good health (able to perform most daily activities) **You may NOT be eligible if...** - You have received bevacizumab (an anti-cancer drug) in the past 3 months - Your tumor has spread to multiple areas of the brain or outside the brain - You have a serious heart condition or abnormal heart rhythm - You are pregnant or breastfeeding - You are currently on certain medications that interact with the study drug (e.g., carbamazepine, phenytoin) - You have active hepatitis B or C Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDSP-0390

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.


Locations(1)

Washington University School of Medicine

St Louis, Missouri, United States

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NCT06636162


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