Glioma, MalignantEarly Phase 1NCT06636162
Window of Opportunity Study of DSP-0390 in Gliomas
A Early Phase 1 study testing DSP-0390 in people with Glioma, Malignant and IDH Mutation, run by Washington University School of Medicine at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioma, Malignant, IDH Mutation
- What is being tested?
- DSP-0390
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Apr 2025to 17 May 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have either newly diagnosed and suspected glioma per radiographic features, or radiographic recurrence of a histologically confirmed IDH-mutant glioma with the following grade requirements:
- 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.
- Patient must be a candidate for surgical resection
- At least 18 years of age.
- Karnofsky ≥ 70%
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- 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
- 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 (according to the local institution standard) and the patient has been on a stable anticoagulant regimen for at least 2 weeks prior to Day 1.
- Creatinine Clearance of ≥40 mL/min per Cockroft-Gault formula or by a 24 hour urine.
- If a patient is using an antiepileptic medication, the patient is on a stable dose and without seizures for 14 days prior to Day 1. The antiepileptic medication used must not fall under any prohibited therapy category as defined in the protocol.
- If the patient is receiving corticosteroids at baseline, the dose administered is stable or decreasing for at least 5 days prior to Day 1. A higher stable dose of corticosteroids, if used as hormone replacement therapy, may be allowed upon discussion with the sponsor-investigator.
- The effects of DSP-0390 on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception (2 forms of acceptable contraception, including one barrier method) prior to study entry, for the duration of study participation, and for 6 months after the last dose of DSP-0390. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
- Ability to understand and willingness to sign an IRB approved written informed consent document.
Who cannot join
- 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.
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- 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.
- Patient has significant cardiovascular disease, including New York Heart Association (NYHA) Class III or IV congestive heart failure, myocardial infarction, unstable angina, pectoris, clinically significant cardiac arrhythmias, or stroke in the preceding 6 months prior to Day 1.
- Uncontrolled intercurrent illness including, but not limited to, psychiatric illness/social situations that would limit compliance with study requirements, disorders associated with significant immunocompromised state, or ongoing or active infection.
- Pregnant and/or breastfeeding. Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose of DSP-0390.
- Patients with HIV are eligible unless their CD4+ T-cell counts are <350 cells/mcL or they have a history of AIDS-defining opportunistic infection within the 12 months prior to registration. Concurrent treatment with effective ART according to DHHS treatment guidelines is recommended, as long as the ART agents do not fall under exclusion #8.
- Patient has a known detectable viral load for hepatitis C, or evidence of a hepatitis B surface antigen.
- Patient has had a major non-neurologic surgical procedure, surgical resection, open biopsy, or significant traumatic injury within 4 weeks prior to Day 1 or anticipates needing a major surgical procedure during the course of the study.
- Patient has had a minor surgical procedure, fine needle aspirations, or core biopsies within 7 days prior to Day 1.
- Patient has 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.
- Patient has had radiotherapy within 12 weeks prior to Day 1, unless relapse is confirmed by tumor biopsy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Omar H Butt, M.D., Ph.D., 314-747-4241, omarhbutt@wustl.edu
Omar H Butt, M.D., Ph.D.
About this study
Official title: Early Phase 1 Window of Opportunity Study of Oral DSP-0390 in Gliomas
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
- Glioma, Malignant, IDH Mutation
- Being tested
- DSP-0390
- Keywords
- DSP-0390, IDH-mutant glioma, brain tumor, brain cancer, low grade glioma, high grade glioma
- Medical subject headings
- Glioma, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DSP-0390Drug
DSP-0390 will be administered orally with preferably 200 mL of water, or approximately one-half cup water. The patient will take DSP-0390 after a minimum of a 6-hour fast and will fast for 1 hour after taking the dose.
| Study group | Role | What they receive |
|---|---|---|
| Arm A Low Grade Gliomas: DSP-0390 120 mg | Experimental | Patients will be assigned to DSP-0390 120 mg once daily by mouth for approximately 2 weeks and up to 17 days prior to surgical resection, with the final dose being administered the morning of surgery. |
| Arm B High Grade Gliomas: DSP-0390 180 mg | Experimental | Patients will be assigned to DSP-0390 180 mg once daily by mouth for approximately 1 week prior to surgical resection, with the final dose being administered the morning of surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unbound DSP-0390 concentration in non-enhancing tumor tissue
Unbound DSP-0390 concentration in non-enhancing tumor tissue will be quantified using tissue removed during resection after treatment.
Measured: At time of surgery following treatment (estimated to be 2 weeks)
Changes in DSP-0390 concentration in plasma
Unbound DSP-0390 concentration in plasma will be quantified using blood samples taken throughout treatment.
Measured: From start of treatment through end of treatment (estimated to be 2 weeks)
Secondary outcomes (23)
Incidence of treatment emergent adverse events (TEAEs)
Assessed using CTCAE v5.0
Measured: From start of treatment through 30 day follow-up (estimated to be 6 weeks)
Incidence of grade 3 or higher study drug related adverse events (AEs)
Assessed using CTCAE v5.0
Measured: From start of treatment through 30 day follow-up (estimated to be 6 weeks)
Lathosterol levels in non-enhancing tumor tissue
Lathosterol levels in non-enhancing tumor tissue will be quantified using tissue removed during resection after treatment.
Measured: At time of surgery following treatment (estimated to be 2 weeks)
Changes in lathosterol levels in non-enhancing tumor tissue
Lathosterol levels in non-enhancing tumor tissue will be quantified using tissue removed during resection after treatment.
Measured: Baseline and at time of surgery following treatment (estimated to be 2 weeks)
Zymostenol levels in non-enhancing tumor tissue
Zymostenol levels in non-enhancing tumor tissue will be quantified using tissue removed during resection after treatment.
Measured: At time of surgery following treatment (estimated to be 2 weeks)
Changes in zymostenol levels in non-enhancing tumor tissue
Zymostenol levels in non-enhancing tumor tissue will be quantified using tissue removed during resection after treatment.
Measured: Baseline and at time of surgery following treatment (estimated to be 2 weeks)
Lathosterol/zymostenol (L/Z) ratio in non-enhancing tumor tissue
L/Z ratio in non-enhancing tumor tissue will be quantified using tissue removed during resection after treatment.
Measured: At time of surgery following treatment (estimated to be 2 weeks)
Changes in lathosterol/zymostenol (L/Z) ratio in non-enhancing tumor tissue
L/Z ratio in non-enhancing tumor tissue will be quantified using tissue removed during resection after treatment.
Measured: Baseline and at time of surgery following treatment (estimated to be 2 weeks)
Changes in lathosterol levels in blood
Change in lathosterol levels in blood will be quantified after 5 days of DSP-0390 dosing.
Measured: From start of treatment through 5 days of treatment
Changes in lathosterol levels in blood
Change in lathosterol levels in blood will be quantified after 10 days of DSP-0390 dosing.
Measured: From start of treatment through 10 days of treatment
Changes in lathosterol levels in blood
Change in lathosterol levels in blood will be quantified after 11 days of DSP-0390 dosing.
Measured: From start of treatment through 11 days of treatment
Changes in lathosterol levels in blood
Change in lathosterol levels in blood will be quantified after 15 days of DSP-0390 dosing.
Measured: From start of treatment through day 15
Changes in lathosterol levels in blood
Change in lathosterol levels in blood will be quantified after surgical resection.
Measured: From start of treatment through day 16
Changes in zymostenol levels in blood
Change in zymostenol levels in blood will be quantified after 5 days of DSP-0390 dosing.
Measured: From start of treatment through 5 days of treatment
Changes in zymostenol levels in blood
Change in zymostenol levels in blood will be quantified after 10 days of DSP-0390 dosing.
Measured: From start of treatment through 10 days of treatment
Changes in zymostenol levels in blood
Change in zymostenol levels in blood will be quantified after 11 days of DSP-0390 dosing.
Measured: From start of treatment through 11 days of treatment
Changes in zymostenol levels in blood
Change in zymostenol levels in blood will be quantified after 15 days of DSP-0390 dosing.
Measured: From start of treatment through day 15
Changes in zymostenol levels in blood
Change in zymostenol levels in blood will be quantified after surgical resection.
Measured: From start of treatment through day 16
Changes in L/Z ratio in blood
Change in L/Z ratio in blood will be quantified after 5 days of DSP-0390 dosing.
Measured: From start of treatment through 5 days of treatment
Changes in L/Z ratio in blood
Change in L/Z ratio in blood will be quantified after 10 days of DSP-0390 dosing.
Measured: From start of treatment through 10 days of treatment
Changes in L/Z ratio in blood
Change in L/Z ratio in blood will be quantified after 11 days of DSP-0390 dosing.
Measured: From start of treatment through 11 days of treatment
Changes in L/Z ratio in blood
Change in L/Z ratio in blood will be quantified after 15 days of DSP-0390 dosing.
Measured: From start of treatment through day 15
Changes in L/Z ratio in blood
Change in L/Z ratio in blood will be quantified after surgical resection.
Measured: From start of treatment through day 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start3 Apr 2025
- Primary completion17 Apr 2027 (estimated)
- Study completion17 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioma, MalignantStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Sumitomo Pharma America, Inc., The Foundation for Barnes-Jewish Hospital
- Responsible party
- Sponsor
- Investigators
- Omar H Butt, M.D., Ph.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06636162
- Sponsor's protocol ID
- 202412002
- Status last verified
- Apr 2026
- First submitted
- 8 Oct 2024
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Phase 1 Window of Opportunity Study of Oral DSP-0390 in Gliomas
- ClinicalTrials.gov ID
- NCT06636162
- Acronym / sponsor ID
- 202412002
- Conditions
- Glioma, Malignant, IDH Mutation
- Keywords
- DSP-0390, IDH-mutant glioma, brain tumor, brain cancer, low grade glioma, high grade glioma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Sumitomo Pharma America, Inc., The Foundation for Barnes-Jewish Hospital
- Study start
- 3 Apr 2025 (actual)
- Primary completion
- 17 Apr 2027 (estimated)
- Study completion
- 17 May 2027 (estimated)
- First posted
- 10 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A Low Grade Gliomas: DSP-0390 120 mg | Experimental | –Patients will be assigned to DSP-0390 120 mg once daily by mouth for approximately 2 weeks and up to 17 days prior to surgical resection, with the final dose being administered the morning of surgery. |
| Arm B High Grade Gliomas: DSP-0390 180 mg | Experimental | –Patients will be assigned to DSP-0390 180 mg once daily by mouth for approximately 1 week prior to surgical resection, with the final dose being administered the morning of surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Patients must have either newly diagnosed and suspected glioma per radiographic features, or radiographic recurrence of a histologically confirmed IDH-mutant glioma with the following grade requirements:
- 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:
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DSP-0390DSP-0390 will be administered orally with preferably 200 mL of water, or approximately one-half cup water. The patient will take DSP-0390 after a minimum of a 6-hour fast and will fast for 1 hour after taking the dose. | Drug | – |
Primary outcome
Unbound DSP-0390 concentration in non-enhancing tumor tissue
Time frame: At time of surgery following treatment (estimated to be 2 weeks)
Unbound DSP-0390 concentration in non-enhancing tumor tissue will be quantified using tissue removed during resection after treatment.
Changes in DSP-0390 concentration in plasma
Time frame: From start of treatment through end of treatment (estimated to be 2 weeks)
Unbound DSP-0390 concentration in plasma will be quantified using blood samples taken throughout treatment.
23 secondary outcomes
Incidence of treatment emergent adverse events (TEAEs)
Time frame: From start of treatment through 30 day follow-up (estimated to be 6 weeks)
Incidence of grade 3 or higher study drug related adverse events (AEs)
Time frame: From start of treatment through 30 day follow-up (estimated to be 6 weeks)
Lathosterol levels in non-enhancing tumor tissue
Time frame: At time of surgery following treatment (estimated to be 2 weeks)
Changes in lathosterol levels in non-enhancing tumor tissue
Time frame: Baseline and at time of surgery following treatment (estimated to be 2 weeks)
Zymostenol levels in non-enhancing tumor tissue
Time frame: At time of surgery following treatment (estimated to be 2 weeks)
Changes in zymostenol levels in non-enhancing tumor tissue
Time frame: Baseline and at time of surgery following treatment (estimated to be 2 weeks)
Lathosterol/zymostenol (L/Z) ratio in non-enhancing tumor tissue
Time frame: At time of surgery following treatment (estimated to be 2 weeks)
Changes in lathosterol/zymostenol (L/Z) ratio in non-enhancing tumor tissue
Time frame: Baseline and at time of surgery following treatment (estimated to be 2 weeks)
Changes in lathosterol levels in blood
Time frame: From start of treatment through 5 days of treatment
Changes in lathosterol levels in blood
Time frame: From start of treatment through 10 days of treatment
Changes in lathosterol levels in blood
Time frame: From start of treatment through 11 days of treatment
Changes in lathosterol levels in blood
Time frame: From start of treatment through day 15
Changes in lathosterol levels in blood
Time frame: From start of treatment through day 16
Changes in zymostenol levels in blood
Time frame: From start of treatment through 5 days of treatment
Changes in zymostenol levels in blood
Time frame: From start of treatment through 10 days of treatment
Changes in zymostenol levels in blood
Time frame: From start of treatment through 11 days of treatment
Changes in zymostenol levels in blood
Time frame: From start of treatment through day 15
Changes in zymostenol levels in blood
Time frame: From start of treatment through day 16
Changes in L/Z ratio in blood
Time frame: From start of treatment through 5 days of treatment
Changes in L/Z ratio in blood
Time frame: From start of treatment through 10 days of treatment
Changes in L/Z ratio in blood
Time frame: From start of treatment through 11 days of treatment
Changes in L/Z ratio in blood
Time frame: From start of treatment through day 15
Changes in L/Z ratio in blood
Time frame: From start of treatment through day 16
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Omar H Butt, M.D., Ph.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing DSP-0390 in people with Glioma, Malignant and IDH Mutation, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Omar H Butt, M.D., Ph.D. (314-747-4241, omarhbutt@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unbound DSP-0390 concentration in non-enhancing tumor tissue (time frame: At time of surgery following treatment (estimated to be 2 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.