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Window of Opportunity Study of DSP-0390 in Gliomas | Clinical Trials | Clareo Health

RECRUITINGEARLY_PHASE1

Window of Opportunity Study of DSP-0390 in Gliomas

Early Phase 1 Window of Opportunity Study of Oral DSP-0390 in Grade II and III Gliomas

NCT06636162•Washington University School of Medicine

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Either newly diagnosied, suspected lower grade glioma per radiographic features, or radiographic recurrence of a histologically confirmed grade II or III IDH-mutant glioma.
•Patient must be a candidate for surgical resection
•At least 18 years of age.
•Karnofsky ≥ 70%
•Adequate bone marrow and organ function as defined below:
•* Absolute neutrophil count ≥ 1.5 K/cumm (patient may not use G-CSF or GM-CSF to achieve this ANC level)
•* Platelets ≥ 100 K/cumm
•* Hemoglobin ≥ 9 g/dL (patient may not receive transfusion or use erythropoietin to obtain this Hgb level)
•* Total bilirubin ≤ 1.5 x IULN (or ≤ 3 x IULN for patients with known Gilbert's syndrome)
•* AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN
+6 more criteria

Exclusion Criteria

•Patient has had prior therapy with bevacizumab or other anti-vascular endothelial growth factor (VEGF) treatments within 3 months prior to Day 1.
•Patient has multifocal disease, leptomeningeal metastasis, or extracranial metastasis.
•Patient has a clinically significant abnormal ECG, including those where QT prolongation is determined by the Fridericia formula (QTcF \>450 msec for males and \>470 msec for females); and/or the patient has a history of Torsade de Pointes.
•Patient is known to have dysphagia, short-gut syndrome, gastroparesis, or other condition that may limit the ingestion or gastrointestinal absorption of drugs administered orally.
•Patient is known to have active Crohn's or other inflammatory bowel disease.
•A history of other malignancy for which all treatment was completed at least 2 years before Day 1 and the patient has no evidence of disease. Exceptions include non-melanoma skin cancer, cervical carcinoma in situ, and superficial bladder cancer that has been removed or curatively treated.
•On active treatment for other, unrelated malignancy or currently receiving any other investigational agents.
•A history of allergic reactions attributed to compounds of similar chemical or biologic composition to DSP-0390.
•Patient has taken concurrent use of prohibited medications: carbamazepine, phenytoin, phenobarbital, and other strong or moderate CYP3A4 inhibitors or inducers, and strong CYP2D6 inhibitors within 1 week or 5 half-lives (whichever is greater) prior to Day 1 or expects to use them during the study. Note both oral and IV ondansetron at doses ≤ 8mg q6 hours are permitted.
•The presence of any active retinal abnormality determined by screening ophthalmologic examination.
+9 more criteria

Locations (1)

Washington University School of Medicine

St Louis, Missouri, United States

Key Dates

Start Date

April 3, 2025

Primary Completion Date

April 17, 2026

Completion Date

May 17, 2026

Last Updated

February 23, 2026

Enrollment

ESTIMATED participants

Conditions

Glioma, MalignantGrade II GliomaIDH Mutation

Interventions

DSP-0390

DRUG

Contacts

Omar H Butt, M.D., Ph.D.

CONTACT

314-747-4241 omarhbutt@wustl.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 23, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Window of Opportunity Study of DSP-0390 in Gliomas

Inclusion Criteria

Exclusion Criteria

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