Window of Opportunity Study of DSP-0390 in Gliomas (NCT06636162) | Clinical Trial Compass
RecruitingEarly Phase 1
Window of Opportunity Study of DSP-0390 in Gliomas
United States20 participantsStarted 2025-04-03
Plain-language 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. 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
* 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%
* 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 i…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This is a Phase 1 'window of opportunity' study, which means DSP-0390 is being given before surgery to measure how much of the drug actually reaches the tumor tissue — can you explain what that means for what we'd learn versus what direct benefit I might personally get from participating?
2Since the trial is specifically for IDH-mutant gliomas, can you confirm whether my tumor's IDH mutation status makes me a potential candidate to even discuss this trial with you?
3The study is measuring drug concentrations in non-enhancing tumor tissue and in blood plasma, so it sounds like it's focused on whether the drug can reach the tumor rather than whether it shrinks it — how does that affect how you'd think about this compared to standard treatment options for my specific situation?
4Because this is an early-phase study and DSP-0390 is being tested in people before its full safety profile is established, what side effects or unknowns should I be aware of when weighing this against more established treatment paths?
5Since this involves taking an experimental drug in the window before my planned surgery, could participating in this trial affect my surgical timeline or complicate the surgery itself in any way?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Unbound DSP-0390 concentration in non-enhancing tumor tissue
Timeframe: At time of surgery following treatment (estimated to be 2 weeks)
2
Changes in DSP-0390 concentration in plasma
Timeframe: From start of treatment through end of treatment (estimated to be 2 weeks)