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OncoMatch/Clinical Trials/NCT06636162

Window of Opportunity Study of DSP-0390 in Gliomas

Is NCT06636162 recruiting? Yes, currently enrolling (Sep 2026). This Early Phase 1 trial studies DSP-0390 for glioma, malignant.

Early Phase 1RecruitingWashington University School of MedicineNCT06636162Data as of Sep 2026

Treatment: DSP-0390This 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.

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Extracted eligibility criteria

Treatments studied

Other

DSP-0390

Cancer type

Glioblastoma

Biomarker criteria

Required: IDH1 mutation

Required: IDH2 mutation

Disease stage

Required: Stage II, III, IV

Grade: II, III, IV

ARM A: suspected lower grade glioma, or histologically confirmed grade II IDH-mutant glioma OR ARM B: suspected high grade glioma, or histologically confirmed grade III or IV glioma

Lab requirements

Blood counts

Absolute neutrophil count  1.5 K/cumm (no G-CSF or GM-CSF to achieve this ANC level); Platelets  100 K/cumm; Hemoglobin  9 g/dL (no transfusion or erythropoietin to obtain this Hgb level)

Kidney function

Creatinine Clearance of 40 mL/min per Cockroft-Gault formula or by a 24 hour urine

Liver function

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

Cardiac function

International normalized ratio (INR), prothrombin time (PT), partial thromboplastin time (PTT), or activated partial thromboplastin time (aPTT) 1.5 x ULN. The use of anticoagulants is permitted as long as the PT/(a)PTT is within therapeutic limits and the patient has been on a stable anticoagulant regimen for at least 2 weeks prior to Day 1.

Adequate bone marrow and organ function as defined below: ... see full text

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Washington University School of Medicine · St Louis, Missouri

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Frequently asked questions

Is NCT06636162 currently recruiting?

Yes, this trial is currently recruiting patients.

Does this trial require IDH1?

Yes, IDH1 mutation is a required biomarker for enrollment.

Does this trial require IDH2?

Yes, IDH2 mutation is a required biomarker for enrollment.

What disease stage is eligible?

Stage II or III or IV is required.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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