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Anti-tumor antibiotic

DSP-0390 for Brain Tumors

Phase < 1

Waitlist Available

Led By Albert H Kim, M.D., Ph.D.

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

At least 18 years of age

Patient must be a candidate for surgical resection where the estimated resected tumor volume would be at least 8 cc

Must not have

Multifocal disease, leptomeningeal metastasis, or extracranial metastasis

Prior therapy with bevacizumab or other anti-VEGF treatments within 3 months prior to Day 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from start of treatment through 30 day follow-up (estimated to be 6 weeks)

Awards & highlights

No Placebo-Only Group

Summary

This trial will study how a drug called DSP-0390 affects the brain and blood of patients with a specific type of brain tumor. Tissue samples will be collected during surgery, and blood samples will

Who is the study for?

This trial is for patients with IDH-mutant WHO grade II or III glioma, a type of brain tumor. Participants must be scheduled for tumor resection surgery and willing to have tissue collected during the procedure. They should also agree to blood draws over two weeks of treatment.

What is being tested?

The study tests DSP-0390's effects in the brain and blood of glioma patients. It aims to see if this drug reaches effective levels in brain tumors and whether it can cause cancer cells to die by targeting cholesterol metabolism changes caused by mutant IDH.

What are the potential side effects?

Potential side effects are not explicitly listed but may include reactions related to altering cholesterol metabolism within the body, as well as typical risks associated with taking new medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am eligible for surgery to remove a tumor larger than 8 cc.

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My brain tumor is either suspected to be low-grade or confirmed to be a grade II or III IDH-mutant glioma.

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I am able to care for myself but may not be able to do active work.

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My blood counts and organ functions are within the required ranges.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer has spread to multiple areas, including the brain's lining or beyond.

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I haven't taken bevacizumab or similar drugs in the last 3 months.

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I do not have conditions like Crohn's that affect my ability to take or absorb drugs.

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I have never had an abnormal heart rhythm or Torsade de Pointes.

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I am not taking any prohibited medications and do not have an active eye condition.

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I do not have serious heart disease or other uncontrolled illnesses.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from start of treatment through 30 day follow-up (estimated to be 6 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from start of treatment through 30 day follow-up (estimated to be 6 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from start of treatment through 30 day follow-up (estimated to be 6 weeks) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Changes in DSP-0390 concentration in plasma

Unbound DSP-0390 concentration in non-enhancing tumor tissue

Secondary study objectives

Changes in L/Z ratio in blood

Changes in lathosterol levels in blood

Changes in zymostenol levels in blood

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: DSP-0390 240 mgExperimental Treatment1 Intervention

The next 10 patients will be assigned to DSP-0390 240 mg once daily by mouth for 2 weeks prior to surgical resection, with the final dose being administered the morning of surgery.

Group II: DSP-0390 120 mgExperimental Treatment1 Intervention

The first 10 patients will be assigned to DSP-0390 120 mg once daily by mouth for 2 weeks prior to surgical resection, with the final dose being administered the morning of surgery.

0 / 11Eligibility criteria met