High Grade GliomaEarly Phase 1NCT05023551
Study of DSP-0390 in Patients With Recurrent High-Grade Glioma
A Early Phase 1 study testing DSP-0390 in people with High Grade Glioma and Glioblastoma Multiforme, run by Sumitomo Pharma America, Inc. at 9 sites in 2 countries.
Trial summary
This is a study of DSP-0390 in patients with recurrent high grade glioma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- High Grade Glioma, Glioblastoma Multiforme
- 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
- 39 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 8 Sep 2021to 31 Oct 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
- Estimated life expectancy >+3 months Recovery from toxic effects of prior therapy to NCI CTCAE v5.0 Grade 1 (non-hematologic toxicities) or Grade <=2(hematologic toxicities, except deep vein thrombosis) KPS >=70%
- Adequate organ function as determined by:
- Absolute Neutrophil ≥1500/microliter (may not use G-CSF or GM CSF)
- Platelet ≥100 × 103/microliter
- Hemoglobin ≥9 g/dL (may not transfuse or use erythropoietin to obtain this Hgb level)
- Creatinine Clearance ≥ 40ml/min (Cockcroft-Gault)
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- Total bilirubin ≤1.5 times ULN (or ≤ 2 times ULN for patients with known Gilbert's syndrome)
- AST ≤ 3 times ULN
- ALT ≤ 3 times ULN
- INR, PT, PTT, or aPTT ≤1.5 x ULN Note: 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 study Day 1.
- If on antiepileptic drug; dose must be stable and no seizures 14 days prior to study Day 1 If on corticosteroids at baseline, dose must be stable or decreasing for at least 5 days prior to study Day 1. For the dose expansion part of the study, the dose must be ≤ 4 mg dexamethasone per day (or equivalent dose if other corticosteroids are used). A higher stable dose of corticosteroids, if used as HRT, may be allowed upon discussion with the Medical Monitor.
- Females of childbearing potential must have a negative serum or urine pregnancy test Male or female patients of child-producing potential must agree to use contraception or use prevention of pregnancy measures or agreement to refrain completely from heterosexual intercourse during the study and for 6 months (females \& males) after the last dose of study drug
Who cannot join
- Prior therapy with bevacizumab or other anti-vascular endothelial growth factor (VEGF) treatments within 3 months prior to study Day 1, Multifocal disease, leptomeningeal metastasis, or extracranial metastasis Abnormal ECGs that are clinically significant, including those where QT prolongation (QTcF>450 msec for males and >470 msec for females); and/or history of Torsade de Pointes Left ventricular ejection fraction <40% as determined by ECHO or MUGA Known dysphagia, short-gut syndrome, gastroparesis, or other conditions that limit the ingestion or gastrointestinal absorption of drugs administered orally Know active Crohn's or other inflammatory bowel disease History of another primary cancer within the 2 years prior to study Day 1, except for the following: non-melamona skin cancer, cervical carcinoma in situ, superficial bladder cancer that has been removed or curatively treated.
- Have a known detectable viral load for HIV or HVC, or evidence of a HBV surface antigen, all being indicative of active infection. [Note: Female breastfeeding patients may be enrolled if they interrupt breastfeeding. Breastfeeding should not be resumed for at least 6 months after the last dose of study drug.]
- The presence of any active retinal abnormality determined by screening tests using visual acuity, visual field, fundoscopy, and OCT
- Significant cardiovascular disease, including NYHA Class III or IV congestive heart failure, myocardial infarction, unstable angina, poorly controlled cardiac arrhythmias, or stroke in the preceding 6 months prior to study Day 1
- Uncontrolled intercurrent illness including, but not limited to, psychiatric illness/social situations that would limit compliance with study requirements, or disorders associated with significant immunocompromised state
- Major surgical procedure, surgical resection, open biopsy, or significant traumatic injury within 4 weeks prior to study Day 1 or anticipation of need for major surgical procedure during the course of the study
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- Minor surgical procedures, fine needle aspirations, or core biopsies within 7 days prior to study Day 1
- Evidence of CNS hemorrhage on baseline MRI or CT scan (except for postsurgical, asymptomatic, Gr 1 hemorrhage that has been stable at least 4 weeks for enrolled patients) Chemotherapy or investigational anticancer therapy administered within 4 weeks (except 6 weeks for nitrosoureas and immunotherapy, or 8 weeks for an implanted nitrosoureas wafer) prior to study Day 1
- Radiotherapy within 12 weeks prior to study Day 1, unless relapse is confirmed by tumor biopsy or new lesion outside of radiation field, or if there are 2 MRIs (performed 8 weeks apart) confirming progressive disease
- Concurrent use of prohibited medications: carbamazepine, phenytoin, phenobarbital, and other strong or moderate CYP3A4 inhibitors or inducers, and strong CYP2D6 inhibitors. These should be discontinued 1 week or 5 half-lives (whichever is greater) prior to study Day 1
- Concurrent treatment with Tumor Treatment Field (Optune) is not allowed. Patients must stop Optune 1 day prior to the first dose of study drug. Any wounds from Optune must be healed adequately prior to study Day 1
- History of, within 6 months of study Day 1:
- Pneumonitis or interstitial lung disease
- Any other lung condition that in the investigators' judgement may put the patient at an increased risk for lung toxicity (including, but not limited to, suspected interstitial lung disease or radiation-induced lung injury)
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
United States6 sites
Dana Farber Cancer Institute
Boston, Massachusetts, 10032
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601
Columbia University
New York, New York, 10032
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, 84112
University of California at San Francisco
San Francisco, California, 94143
Washington University School of Medicine
St Louis, Missouri, 63110
Japan3 sites
National Cancer Center Hospital
Chuo Ku, Tokyo, 104-0045
Kyoto University Hospital
Kyoto, Sakyo-ku, 606-8507
Hokkaido University Hospital
Sapporo, Hokkaido, 060-8648
About this study
Official title: A Phase 1 Study of DSP-0390 in Patients With Recurrent High-Grade Glioma
This is a study of DSP-0390 in patients with recurrent high grade glioma.
Read the detailed description
This study will evaluate the safety and efficacy of DSP-0390 in patients with recurrent high grade glioma.
- Conditions
- High Grade Glioma, Glioblastoma Multiforme
- Being tested
- DSP-0390
- Keywords
- High grade glioma, Glioblastoma Multiforme (GMB), Brain Tumor, Emopamil binding protein, 3-beta-hydroxysteroid-Delta(8),Delta(7)-isomerase
- Medical subject headings
- Glioma, Glioblastoma, 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 administered orally
| Study group | Role | What they receive |
|---|---|---|
| Single arm DSP-0390 | Experimental | Arm Description [*] DSP-0390 by oral administration Receives: Drug: DSP-0390 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Escalation: Assess safety of DSP-0390 by Incidence of TEAEs and SAEs in adult patients with recurrent high-grade glioma
Occurrence of DLTs by Incidence of TEAEs and SAEs, as assessed by NCI CTCAE v5.0
Measured: From date of treatment through 30 days after End of Treatment an average of 6 months
Dose Escalation: Assess safety of DSP-0390 by severity of TEAEs and SAEs in adult patients with recurrent high-grade glioma
Occurrence of DLTs by severity of TEAEs and SAEs, as assessed by NCI CTCAE v5.0
Measured: From date of treatment through 30 days after End of Treatment an average of 6 months
Dose Escalation: Determine the MTD and/or RDE of DSP-0390
Incidence of dose-limiting toxicities
Measured: From date of first treatment through Cycle 1 (28-day cycle) DLT monitoring period
Dose Expansion: Evaluate the change in Baseline tumor activity of DSP-0390 using radiologic assessments.
Evaluate the change in baseline tumor activity of DSP-0390 using radiologic assessments evaluated by RANO 2010 Evaluation Criteria
Measured: From date of first treatment, assessed by radiologic examination performed at 8-week intervals through study completion, an average of 6 months
Dose Expansion: Evaluate the safety of the Recommended Phase 2 Dose of DSP-0390 by assessment of incidence of TEAEs and SAEs
Assess the safety of the Recommended Phase 2 Dose of DSP-0390 by assessment of incidence of TEAEs and SAEs
Measured: From date of first treatment through study completion, an average of 6 months
Dose Expansion: Evaluate the safety of the Recommended Phase 2 Dose by assessment of severity of TEAEs and SAEs
Assess the safety of the Recommended Phase 2 Dose of DSP-0390 by assessment of severity of TEAEs and SAEs
Measured: From date of first treatment through study completion, an average of 6 months
Assess safety of DSP-0390 by Incidence of SAEs in adult patients with recurrent high-grade glioma consented under Protocol Amendment 5
Incidence of SAEs, as assessed by NCI CTCAE v5.0
Measured: From date of treatment through 30 days after End of Treatment an average of 12 months
Assess safety of DSP-0390 by Incidence of AEs resulting in study discontinuation in adult patients with recurrent high-grade glioma consented under Protocol Amendment 5
Incidence of AEs resulting in study discontinuation, as assessed by NCI CTCAE v5.0
Measured: From date of treatment through 30 days after End of Treatment an average of 12 months
Secondary outcomes (6)
Dose Escalation: Characterize the PK profile for AUC
PK assessed for AUC
Measured: Cycle 1 Day 1 and Cycle 2 Day 1- 0, 30 min, and 1, 2, 4, 6, 8, 10, 12 hrs, each cycle is 28 days
Dose Escalation: Characterize the PK profile for Cmax
PK assessed for Cmax
Measured: Cycle 1 Day 1 and Cycle 2 Day 1 -0, 30 min, and 1, 2, 4, 6, 8, 10, 12 hrs , each cycle is 28 days
Dose Escalation: Characterize the PK profile for tmax
PK assessed for tmax
Measured: Cycle 1 Day 1 and Cycle 2 Day 1- 0, 30 min, and 1, 2, 4, 6, 8, 10, 12 hrs , each cycle is 28 days
Dose Escalation: Characterize the PK profile for t1/2
PK assessed for t1/2
Measured: From date of first treatment, Cycle 1 Day 1 and Cycle 2 Day 1- 0, 30 min, and 1, 2, 4, 6, 8, 10, 12 hrs , each cycle is 28 days]
Dose Escalation: Characterize the PK profile for Racc
PK assessed for Racc
Measured: Cycle 1 Day 8, 15 and 22 and Cycle 2 Day 1, each cycle is 28 days
Dose Escalation: Evaluate preliminary antitumor activity
Objective response (complete or partial response) and duration of response assessed by RANO criteria.
Measured: From date of first treatment, assessed by radiologic examination performed at 8-week intervals through study completion, an average of 6 months]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2021
- Study start8 Sep 2021
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Grade GliomaStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- This is a Phase 1 dose-escalation study with a Part 2 expansion to evaluate the safety, PK, PD, and preliminary antitumor activity of orally administered DSP 0390 in patients with recurrent high-grade glioma. Patients in this study will receive DSP-0390 orally once daily. The study will be divided into 28-day cycles for safety and response assessments. Patients will continue treatment until progression of disease, unacceptable toxicity, withdrawal of consent, loss to follow-up, or discontinuation of the patient by the investigator. Dose-escalation will evaluate increasing dose levels of DSP-0390 to determine the MTD and/or a suitable lower dose for expansion (the RDE) in patients with recurrent WHO Grade III or IV malignant glioma. Once the MTD and/or RDE has been established, the dose escalation (Part 2) will evaluate preliminary clinical activity and the safety and tolerability of DSP-0390 in patients with recurrent WHO Grade 4 glioblastoma multiforme (GBM).
- Masking
- None (open label)
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sumitomo Pharma America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jian Li, MD, Study director, Sumitomo Pharma America, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05023551
- Sponsor's protocol ID
- DSP-0390-101
- Status last verified
- Jul 2026
- First submitted
- 27 Jul 2021
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of DSP-0390 in Patients With Recurrent High-Grade Glioma
- ClinicalTrials.gov ID
- NCT05023551
- Acronym / sponsor ID
- DSP-0390-101
- Conditions
- High Grade Glioma, Glioblastoma Multiforme
- Keywords
- High grade glioma, Glioblastoma Multiforme (GMB), Brain Tumor, Emopamil binding protein, 3-beta-hydroxysteroid-Delta(8),Delta(7)-isomerase
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Sumitomo Pharma America, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Sep 2021 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 26 Aug 2021 (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 is a study of DSP-0390 in patients with recurrent high grade glioma.
Detailed description
This study will evaluate the safety and efficacy of DSP-0390 in patients with recurrent high grade glioma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a Phase 1 dose-escalation study with a Part 2 expansion to evaluate the safety, PK, PD, and preliminary antitumor activity of orally administered DSP 0390 in patients with recurrent high-grade glioma. Patients in this study will receive DSP-0390 orally once daily. The study will be divided into 28-day cycles for safety and response assessments. Patients will continue treatment until progression of disease, unacceptable toxicity, withdrawal of consent, loss to follow-up, or discontinuation of the patient by the investigator. Dose-escalation will evaluate increasing dose levels of DSP-0390 to determine the MTD and/or a suitable lower dose for expansion (the RDE) in patients with recurrent WHO Grade III or IV malignant glioma. Once the MTD and/or RDE has been established, the dose escalation (Part 2) will evaluate preliminary clinical activity and the safety and tolerability of DSP-0390 in patients with recurrent WHO Grade 4 glioblastoma multiforme (GBM).
| Arm | Type | Receives |
|---|---|---|
| Single arm DSP-0390 | Experimental | Drug: DSP-0390Arm Description [*] DSP-0390 by oral administration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Estimated life expectancy >+3 months Recovery from toxic effects of prior therapy to NCI CTCAE v5.0 Grade 1 (non-hematologic toxicities) or Grade <=2(hematologic toxicities, except deep vein thrombosis) KPS >=70%
- Absolute Neutrophil ≥1500/microliter (may not use G-CSF or GM CSF)
- Platelet ≥100 × 103/microliter
- Hemoglobin ≥9 g/dL (may not transfuse or use erythropoietin to obtain this Hgb level)
- Creatinine Clearance ≥ 40ml/min (Cockcroft-Gault)
Key exclusion criteria (14 listed)
- Prior therapy with bevacizumab or other anti-vascular endothelial growth factor (VEGF) treatments within 3 months prior to study Day 1, Multifocal disease, leptomeningeal metastasis, or extracranial metastasis Abnormal ECGs that are clinically significant, including those where QT prolongation (QTcF>450 msec for males and >470 msec for females); and/or history of Torsade de Pointes Left ventricular ejection fraction <40% as determined by ECHO or MUGA Known dysphagia, short-gut syndrome, gastroparesis, or other conditions that limit the ingestion or gastrointestinal absorption of drugs administered orally Know active Crohn's or other inflammatory bowel disease History of another primary cancer within the 2 years prior to study Day 1, except for the following: non-melamona skin cancer, cervical carcinoma in situ, superficial bladder cancer that has been removed or curatively treated.
- Have a known detectable viral load for HIV or HVC, or evidence of a HBV surface antigen, all being indicative of active infection. [Note: Female breastfeeding patients may be enrolled if they interrupt breastfeeding. Breastfeeding should not be resumed for at least 6 months after the last dose of study drug.]
- The presence of any active retinal abnormality determined by screening tests using visual acuity, visual field, fundoscopy, and OCT
- Significant cardiovascular disease, including NYHA Class III or IV congestive heart failure, myocardial infarction, unstable angina, poorly controlled cardiac arrhythmias, or stroke in the preceding 6 months prior to study Day 1
- Uncontrolled intercurrent illness including, but not limited to, psychiatric illness/social situations that would limit compliance with study requirements, or disorders associated with significant immunocompromised state
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 administered orally | Drug | Single arm DSP-0390 |
Primary outcome
Dose Escalation: Assess safety of DSP-0390 by Incidence of TEAEs and SAEs in adult patients with recurrent high-grade glioma
Time frame: From date of treatment through 30 days after End of Treatment an average of 6 months
Occurrence of DLTs by Incidence of TEAEs and SAEs, as assessed by NCI CTCAE v5.0
Dose Escalation: Assess safety of DSP-0390 by severity of TEAEs and SAEs in adult patients with recurrent high-grade glioma
Time frame: From date of treatment through 30 days after End of Treatment an average of 6 months
Occurrence of DLTs by severity of TEAEs and SAEs, as assessed by NCI CTCAE v5.0
Dose Escalation: Determine the MTD and/or RDE of DSP-0390
Time frame: From date of first treatment through Cycle 1 (28-day cycle) DLT monitoring period
Incidence of dose-limiting toxicities
Dose Expansion: Evaluate the change in Baseline tumor activity of DSP-0390 using radiologic assessments.
Time frame: From date of first treatment, assessed by radiologic examination performed at 8-week intervals through study completion, an average of 6 months
Evaluate the change in baseline tumor activity of DSP-0390 using radiologic assessments evaluated by RANO 2010 Evaluation Criteria
Dose Expansion: Evaluate the safety of the Recommended Phase 2 Dose of DSP-0390 by assessment of incidence of TEAEs and SAEs
Time frame: From date of first treatment through study completion, an average of 6 months
Assess the safety of the Recommended Phase 2 Dose of DSP-0390 by assessment of incidence of TEAEs and SAEs
Dose Expansion: Evaluate the safety of the Recommended Phase 2 Dose by assessment of severity of TEAEs and SAEs
Time frame: From date of first treatment through study completion, an average of 6 months
Assess the safety of the Recommended Phase 2 Dose of DSP-0390 by assessment of severity of TEAEs and SAEs
Assess safety of DSP-0390 by Incidence of SAEs in adult patients with recurrent high-grade glioma consented under Protocol Amendment 5
Time frame: From date of treatment through 30 days after End of Treatment an average of 12 months
Incidence of SAEs, as assessed by NCI CTCAE v5.0
Assess safety of DSP-0390 by Incidence of AEs resulting in study discontinuation in adult patients with recurrent high-grade glioma consented under Protocol Amendment 5
Time frame: From date of treatment through 30 days after End of Treatment an average of 12 months
Incidence of AEs resulting in study discontinuation, as assessed by NCI CTCAE v5.0
6 secondary outcomes
Dose Escalation: Characterize the PK profile for AUC
Time frame: Cycle 1 Day 1 and Cycle 2 Day 1- 0, 30 min, and 1, 2, 4, 6, 8, 10, 12 hrs, each cycle is 28 days
Dose Escalation: Characterize the PK profile for Cmax
Time frame: Cycle 1 Day 1 and Cycle 2 Day 1 -0, 30 min, and 1, 2, 4, 6, 8, 10, 12 hrs , each cycle is 28 days
Dose Escalation: Characterize the PK profile for tmax
Time frame: Cycle 1 Day 1 and Cycle 2 Day 1- 0, 30 min, and 1, 2, 4, 6, 8, 10, 12 hrs , each cycle is 28 days
Dose Escalation: Characterize the PK profile for t1/2
Time frame: From date of first treatment, Cycle 1 Day 1 and Cycle 2 Day 1- 0, 30 min, and 1, 2, 4, 6, 8, 10, 12 hrs , each cycle is 28 days]
Dose Escalation: Characterize the PK profile for Racc
Time frame: Cycle 1 Day 8, 15 and 22 and Cycle 2 Day 1, each cycle is 28 days
Dose Escalation: Evaluate preliminary antitumor activity
Time frame: From date of first treatment, assessed by radiologic examination performed at 8-week intervals through study completion, an average of 6 months]
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 29 Jul 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Jian Li, MD study director
Sumitomo Pharma America, Inc.
9 sites in 2 countries: 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 High Grade Glioma and Glioblastoma Multiforme, run by Sumitomo Pharma America, Inc. at 9 sites in 2 countries.
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 12 inclusion and 14 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: under way, not looking for participants, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Japan. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Escalation: Assess safety of DSP-0390 by Incidence of TEAEs and SAEs in adult patients with recurrent high-grade glioma (time frame: From date of treatment through 30 days after End of Treatment an average of 6 months). The study lists 8 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 29 Jul 2026.