Actively Recruiting

Early Phase 1
Age: 18Years +
All Genders
NCT06636162

Window of Opportunity Study of DSP-0390 in Gliomas

Led by Washington University School of Medicine · Updated on 2026-05-06

20

Participants Needed

1

Research Sites

110 weeks

Total Duration

On this page

Sponsors

W

Washington University School of Medicine

Lead Sponsor

S

Sumitomo Pharma America, Inc.

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Window of Opportunity Study of DSP-0390 in Gliomas

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients must have newly diagnosed suspected glioma or radiographic recurrence of histologically confirmed IDH-mutant glioma with grade II (ARM A) or grade III/IV (ARM B)
  • Candidate for surgical tumor resection
  • At least 18 years old
  • Karnofsky performance status of 70% or higher
  • Adequate bone marrow and organ function: neutrophils ≥ 1.5 K/cumm without growth factor support, platelets ≥ 100 K/cumm, hemoglobin ≥ 9 g/dL without transfusion or erythropoietin
  • Total bilirubin ≤ 1.5 x upper limit of normal (or ≤ 3 x for Gilbert's syndrome)
  • AST/ALT ≤ 3.0 x upper limit of normal
  • Coagulation labs (INR, PT, PTT, aPTT) ≤ 1.5 x upper limit; stable anticoagulant use allowed
  • Creatinine clearance ≥ 40 mL/min
  • Stable antiepileptic medication dose without seizures for 14 days prior to Day 1
  • Stable or decreasing corticosteroid dose for at least 5 days prior to Day 1
  • Agreement to use adequate contraception during study and for 6 months after last dose
  • Ability to understand and sign informed consent
Not Eligible

You will not qualify if you...

  • Prior therapy with bevacizumab or anti-VEGF treatments within 3 months prior to Day 1
  • Multifocal disease, leptomeningeal or extracranial metastasis
  • Significant abnormal ECG including QT prolongation or history of Torsade de Pointes
  • Conditions limiting oral drug absorption (dysphagia, short-gut syndrome, gastroparesis)
  • Active Crohn's disease or other inflammatory bowel disease
  • History of other malignancy unless disease-free for at least 2 years (exceptions apply)
  • Active treatment for other malignancy or investigational agents
  • History of allergic reactions to compounds similar to DSP-0390
  • Use of prohibited medications (certain CYP3A4 and CYP2D6 inhibitors/inducers) within 1 week or 5 half-lives prior to Day 1
  • Active retinal abnormalities
  • Significant cardiovascular disease (NYHA Class III/IV heart failure, recent MI, unstable angina, serious arrhythmias, recent stroke)
  • Uncontrolled illnesses affecting compliance or immunocompromised state
  • Pregnant or breastfeeding; women of childbearing potential must have negative pregnancy test
  • HIV patients with CD4+ < 350 cells/mcL or recent AIDS-defining infection
  • Detectable hepatitis C viral load or hepatitis B surface antigen
  • Recent major surgery within 4 weeks or anticipated major surgery during study
  • Minor surgery or biopsies within 7 days prior to Day 1
  • Recent chemotherapy or investigational anticancer therapy within 4 weeks (exceptions for certain agents)
  • Radiotherapy within 12 weeks prior to Day 1 unless relapse biopsy confirmed

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Washington University School of Medicine

St Louis, Missouri, United States, 63110

Actively Recruiting

Loading map...

Research Team

O

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

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here