OncoMatch/Clinical Trials/NCT06636162
Window of Opportunity Study of DSP-0390 in Gliomas
Is NCT06636162 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies DSP-0390 for glioma, malignant.
Treatment: DSP-0390 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Glioblastoma
Biomarker criteria
Required: IDH1 mutation
Required: IDH2 mutation
Disease stage
Grade: IIIII
grade II or III IDH-mutant glioma
Prior therapy
Cannot have received: anti-vascular endothelial growth factor therapy (bevacizumab)
prior therapy with bevacizumab or other anti-vascular endothelial growth factor (VEGF) treatments within 3 months prior to Day 1
Cannot have received: chemotherapy
received chemotherapy or investigational anticancer therapy within 4 weeks (except 6 weeks for nitrosoureas and immunotherapy, or 8 weeks for an implanted nitrosoureas wafer) prior to Day 1
Cannot have received: immunotherapy
received chemotherapy or investigational anticancer therapy within 4 weeks (except 6 weeks for nitrosoureas and immunotherapy, or 8 weeks for an implanted nitrosoureas wafer) prior to Day 1
Cannot have received: nitrosoureas
received chemotherapy or investigational anticancer therapy within 4 weeks (except 6 weeks for nitrosoureas and immunotherapy, or 8 weeks for an implanted nitrosoureas wafer) prior to Day 1
Cannot have received: radiation therapy
Exception: unless relapse is confirmed by tumor biopsy
had radiotherapy within 12 weeks prior to Day 1, unless relapse is confirmed by tumor biopsy
Lab requirements
Blood counts
Absolute neutrophil count ≥ 1.5 K/cumm (no G-CSF or GM-CSF to achieve this); Platelets ≥ 100 K/cumm; Hemoglobin ≥ 9 g/dL (no transfusion or erythropoietin to obtain this)
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
clinically significant abnormal ECG, including QTcF >450 msec for males and >470 msec for females; history of Torsade de Pointes
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 ... Creatinine Clearance of ≥40 mL/min per Cockroft-Gault formula or by a 24 hour urine ... 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.
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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