Glioblastoma WHO Grade IVEarly Phase 1NCT06824662
Phase 0 With Expansion Phase Clinical Trial of Quisinostat Plus Radiotherapy in Newly-diagnosed and Recurrent Grade 4 IDH-Wildtype Glioblastomas
A Early Phase 1 study testing Quisinostat in people with Glioblastoma WHO Grade IV, run by Nader Sanai at 1 site in United States.
Trial summary
This is an open-label, multi-center Phase 0/1b study that will enroll up to 18 participants with recurrent WHO grade 4 glioblastoma (rGBM) IDH-wildtype (IDH-WT), Arm A, and 12 participants with presumed newly-diagnosed WHO grade 4 glioblastoma (nGBM) IDH-WT, Arm B. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma WHO Grade IV
- What is being tested?
- Quisinostat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Sep 2025to 14 Jan 2028
- 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
- For Arm A: Participants who have had a prior resection of diagnosed glioblastoma, IDH wildtype (2021 WHO grade 4), defined as participants who have progressed on or following standard therapy, which includes maximal surgical resection, temozolomide, and fractionated radiotherapy. Participants will also need to have radiation planned as part of the post-surgical treatment plan; OR, for Arm B only: Participants undergoing resection for a suspected newly diagnosed WHO Grade 4 glioblastoma, IDH wildtype. Participants will also need to have radiation planned as part of the post-surgical treatment plan.
- Participants must have measurable disease preoperatively, defined as at least 1 contrast-enhancing lesion, with 2 perpendicular measurements of at least 1 cm.
- Provision of signed and dated, written informed consent (personally or by the legally authorized representative, if applicable) prior to any study specific procedures, sampling and analyses.
- Age ≥18 at time of consent
- Have a performance status (PS) of ≤2 on the Eastern Cooperative Oncology Group (ECOG) scale.
- Ability to swallow oral medications.
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- Participant has adequate bone marrow and organ function as defined by the following laboratory values (as assessed by the local laboratory for eligibility):
- Participants with tumor-induced seizures must be well-controlled on a stable anti-epileptic treatment.
- Participants must be willing to receive prophylaxis with levetiracetam for the duration of study drug administration (or alternative anti-epileptic if agreed with Medical Monitor).
- Confirmed negative serum pregnancy test (β-hCG) before starting study treatment or participant who is no longer of childbearing potential due to surgical, chemical, or natural menopause.
- For females of reproductive potential: use of highly effective contraception and agreement to use such a method during study participation until the end of treatment administration and for 16 weeks after the last dose of study drug.
- For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner until the end of treatment administration and for 16 weeks after the last dose of study drug.
- Agreement to adhere to Lifestyle Considerations throughout study duration.
Who cannot join
- Pregnancy or lactation.
- Known allergic reactions to components of the quisinostat.
- Known to have active (acute or chronic) or uncontrolled severe infection, liver disease such as cirrhosis, decompensated liver disease, and active and chronic hepatitis, as determined by the investigator.
- Known active systemic bacterial infection (requiring intravenous [IV] antibiotics or fever >38.5°C at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C [for example, hepatitis B surface antigen positive]. Screening of viral infection is not required for enrollment.
- The participant has a personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest.
- Any of the following cardiac criteria: cardiac dysfunction defined as myocardial infarction within six months of study entry, NYHA Class II/III/IV heart failure, unstable angina or unstable cardiac arrhythmias; mean resting corrected QT interval (QTcF) > 470 msec obtained from 3 electrocardiograms (ECGs) (QTc interval will be calculated using Fridericia's formula); any clinically important abnormalities in rhythm, conduction or morphology of resting ECG, e.g., complete left bundle branch block, third degree heart block; any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years-of-age (patients stable on concomitant medications known to prolong the QT interval may be allowed to participate in the study provided that their mean resting corrected QT interval (QTcF) is < 450 msec in males or < 470msec in females at baseline and after discussion with the Principal Investigator); use of medications that may cause Torsades de Pointes.
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- History or presence of myopathy or raised creatine kinase (CK) > 5 x upper limit of normal (ULN) on 2 occasions at screening.
- Participant has serious and/or uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, severe renal impairment [e.g. estimated creatinine clearance <30 ml/min], history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea).
- Prior therapy with histone-deacetylase inhibitor therapy; more than 3 prior lines of therapy.
- Treatment with strong inhibitors or inducers of CYP3A4 within 2 weeks prior to receiving study drug.
- Prior treatment with pneumotoxic drugs, e.g. busulfan, bleomycin, within the past year. If prior therapy in lifetime, then excluded if history of pulmonary toxicities from administration. Patients who have received treatment with nitrosoureas (e.g., BCNU, CCNU) in the year before study entry without experiencing lung toxicity are allowed on study.
- Treatment with another investigational drug or other intervention within 5 half-lives of the investigational product, whichever is longer.
- With the exception of alopecia, any unresolved toxicities from prior therapy greater than National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 5.0) Grade 1 at the time of starting study treatment and patients with chronic Grade 2 unresolved toxicities may be eligible following discussion with the Principal Investigator.
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013
About this study
Official title: A Phase 0/1b 'Trigger' Clinical Trial With an Expansion Phase of Quisinostat Plus Fractionated Radiotherapy in Newly-diagnosed and Recurrent Grade 4 IDH-WT Glioblastomas
This is an open-label, multi-center Phase 0/1b study that will enroll up to 18 participants with recurrent WHO grade 4 glioblastoma (rGBM) IDH-wildtype (IDH-WT), Arm A, and 12 participants with presumed newly-diagnosed WHO grade 4 glioblastoma (nGBM) IDH-WT, Arm B. The trial will be composed of a Phase 0 component (subdivided into Arms A and B), and an Expansion Phase 1b. Patients with tumors demonstrating a positive pharmacokinetic (PK) response in the Phase 0 component of the study will graduate to an Expansion Phase that combines therapeutic dosing of quisinostat plus standard-of-care fractionated radiotherapy (RT).
Read the detailed description
Eligible participants (rGBM in Arm A and nGBM in Arm B) will enroll in the Phase 0 study and receive quisinostat prior to a planned resection. Arm A includes a 3+3 design to determine optimal time interval (OTI) of final dose prior to surgery. Further rGBM participants and nGBM participants will enroll at OTI once established. Blood, tumor, and cerebrospinal fluid (CSF) samples will be collected during surgery, and blood and CSF samples will be collected after surgery, to measure the amount of drug that is present in the samples. Participants with tumors demonstrating PK response will continue with therapeutic dosing of quisinostat treatment on Monday, Wednesday, Friday of 5-day cycles after surgery concurrently with their standard of care (SOC) fractionated RT. Participants will continue to receive quisinostat and SOC RT for their physician-directed duration of RT, (2-3 weeks for rGBM and 5-6 weeks form nGBM).
The Phase 0 Primary Objective is to evaluate concentration of quisinostat in gadolinium-non-enhancing tumor tissue, and the Expansion Phase Primary Objective is to determine the 6-month progression free survival (PFS6) rate in rGBM participants who had positive PK response in Phase 0.
The Phase 0 Secondary Objective is to evaluate concentration of quisinostat in CSF, and the Expansion Phase Secondary Objectives are to monitor safety and tolerability of quisinostat and examine overall survival (OS) in participants.
- Conditions
- Glioblastoma WHO Grade IV
- Being tested
- Quisinostat
- Keywords
- IDH-WT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuisinostatDrug
a highly potent and orally active HDAC inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Recurrent WHO Grade 4 Glioblastoma IDH-WT | Experimental | Not described Receives: Drug: Quisinostat |
| Newly-Diagnosed WHO Grade 4 Glioblastoma IDH-WT | Experimental | Not described Receives: Drug: Quisinostat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quisinostat Concentration in Tumor Tissue
Total and unbound quisinostat concentration will be quantified in Gd-enhancing and Gd-non-enhancing tumor tissue collected during Phase 0 surgery.
Measured: Phase 0 surgery
6-Month Progression Free Survival (PFS6) Rate in Participants
The rate of 6-month progression-free survival of participants that had a positive PK response (defined as unbound concentrations of quisinostat equal or greater than 0.5 nM in Gd-non-enhancing tumor tissue) will be quantified.
Measured: From date of Phase 0 surgery to date of disease recurrence or death, assessed over 16 months
Secondary outcomes (7)
Quisinostat Concentration in Cerebrospinal Fluid (CSF)
Quisinostat concentration will be quantified in cerebrospinal fluid collected during Phase 0 surgery and throughout study duration of participants with an Ommaya reservoir and shunt placed during surgery.
Measured: From date of Phase 0 surgery through study completion, assessed over 4 months
Number of Participants with Drug-Related Toxicity
Safety and tolerability of quisinostat will be assessed by tabulating the number of drug-related toxicities (graded per CTCAE version 5) which include:
- Grade 2 or higher cardiac disorder
- Grade 4 or higher hematological or nonhematological toxicity
- Febrile neutropenia
- Unacceptable toxicity as determined by the Investigator
- Any Grade 3 or higher non-hematologic toxicity, excluding the following: Grade 3 nausea, vomiting, or diarrhea for less than 72 hours with adequate supportive care; Grade 3 fatigue for longer than 1 week; Grade 3 or higher electrolyte abnormality lasting up to 72 hours, is not clinically complicated, and resolves spontaneously or responds to conventional treatment
Measured: From date of first dose until 30 days after last dose, assessed over 4 months
Number of Treatment-Emergent Adverse Events
Safety and tolerability of quisinostat will be assessed by tabulating participants that had treatment-emergent adverse events according to the highest Grade observed per patient for each event or category (graded per CTCAE version 5).
Measured: From date of enrollment until 30 days after last dose, assessed over 6 months
Number of Treatment-Related Adverse Events
Safety and tolerability of quisinostat will be assessed by tabulating participants that had treatment-related adverse events (defined as those events definitely, probably, or potentially related to study treatment) according to the highest Grade observed per patient for each event or category (graded per CTCAE version 5).
Measured: From date of first dose until 30 days after last dose, assessed over 4 months
Number of Participants with Clinical Laboratory Abnormalities
Safety and tolerability of quisinostat will be assessed by tabulating participants that had clinical laboratory abnormalities stratified by each event or abnormal result.
Measured: From date of first dose until 30 days after last dose, assessed over 4 months
Number of Serious Adverse Events and Deaths
Safety and tolerability of quisinostat will be assessed by aggregating and tabulating participants that died during study participation (due to any cause), and participants that had serious adverse events according to the highest Grade observed per patient for each event or category (graded per CTCAE version 5).
Measured: From date of enrollment until 30 days after last dose, assessed over 6 months
Overall Survival during Expansion Phase
Overall Survival of participants that had a positive PK response (defined as unbound concentrations of quisinostat equal or greater than 0.5 nM in Gd-non-enhancing tumor tissue) will be summarized using Kaplan-Meier Curves and Estimates.
Measured: From date of surgery until death, assessed up to 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2025
- Study start4 Sep 2025
- Primary completion15 Jul 2026 (estimated)
- Study completion14 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioblastoma WHO Grade IVStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nader Sanai
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nader Sanai, St. Joseph's Hospital and Medical Center, Phoenix
- Investigators
- Nader Sanai, MD, Principal investigator, Ivy Brain Tumor Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06824662
- Sponsor's protocol ID
- 2023-18
- Status last verified
- Mar 2026
- First submitted
- 4 Feb 2025
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 0/1b 'Trigger' Clinical Trial With an Expansion Phase of Quisinostat Plus Fractionated Radiotherapy in Newly-diagnosed and Recurrent Grade 4 IDH-WT Glioblastomas
- ClinicalTrials.gov ID
- NCT06824662
- Acronym / sponsor ID
- 2023-18
- Conditions
- Glioblastoma WHO Grade IV
- Keywords
- IDH-WT
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Nader SanaiUniversity, hospital or other
- Study start
- 4 Sep 2025 (actual)
- Primary completion
- 15 Jul 2026 (estimated)
- Study completion
- 14 Jan 2028 (estimated)
- First posted
- 13 Feb 2025 (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 an open-label, multi-center Phase 0/1b study that will enroll up to 18 participants with recurrent WHO grade 4 glioblastoma (rGBM) IDH-wildtype (IDH-WT), Arm A, and 12 participants with presumed newly-diagnosed WHO grade 4 glioblastoma (nGBM) IDH-WT, Arm B. The trial will be composed of a Phase 0 component (subdivided into Arms A and B), and an Expansion Phase 1b. Patients with tumors demonstrating a positive pharmacokinetic (PK) response in the Phase 0 component of the study will graduate to an Expansion Phase that combines therapeutic dosing of quisinostat plus standard-of-care fractionated radiotherapy (RT).
Detailed description
Eligible participants (rGBM in Arm A and nGBM in Arm B) will enroll in the Phase 0 study and receive quisinostat prior to a planned resection. Arm A includes a 3+3 design to determine optimal time interval (OTI) of final dose prior to surgery. Further rGBM participants and nGBM participants will enroll at OTI once established. Blood, tumor, and cerebrospinal fluid (CSF) samples will be collected during surgery, and blood and CSF samples will be collected after surgery, to measure the amount of drug that is present in the samples. Participants with tumors demonstrating PK response will continue with therapeutic dosing of quisinostat treatment on Monday, Wednesday, Friday of 5-day cycles after surgery concurrently with their standard of care (SOC) fractionated RT. Participants will continue to receive quisinostat and SOC RT for their physician-directed duration of RT, (2-3 weeks for rGBM and 5-6 weeks form nGBM).
The Phase 0 Primary Objective is to evaluate concentration of quisinostat in gadolinium-non-enhancing tumor tissue, and the Expansion Phase Primary Objective is to determine the 6-month progression free survival (PFS6) rate in rGBM participants who had positive PK response in Phase 0.
The Phase 0 Secondary Objective is to evaluate concentration of quisinostat in CSF, and the Expansion Phase Secondary Objectives are to monitor safety and tolerability of quisinostat and examine overall survival (OS) in participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recurrent WHO Grade 4 Glioblastoma IDH-WT | Experimental | Drug: Quisinostat |
| Newly-Diagnosed WHO Grade 4 Glioblastoma IDH-WT | Experimental | Drug: Quisinostat |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- For Arm A: Participants who have had a prior resection of diagnosed glioblastoma, IDH wildtype (2021 WHO grade 4), defined as participants who have progressed on or following standard therapy, which includes maximal surgical resection, temozolomide, and fractionated radiotherapy. Participants will also need to have radiation planned as part of the post-surgical treatment plan; OR, for Arm B only: Participants undergoing resection for a suspected newly diagnosed WHO Grade 4 glioblastoma, IDH wildtype. Participants will also need to have radiation planned as part of the post-surgical treatment plan.
- Participants must have measurable disease preoperatively, defined as at least 1 contrast-enhancing lesion, with 2 perpendicular measurements of at least 1 cm.
- Provision of signed and dated, written informed consent (personally or by the legally authorized representative, if applicable) prior to any study specific procedures, sampling and analyses.
- Age ≥18 at time of consent
- Have a performance status (PS) of ≤2 on the Eastern Cooperative Oncology Group (ECOG) scale.
Key exclusion criteria (13 listed)
- Pregnancy or lactation.
- Known allergic reactions to components of the quisinostat.
- Known to have active (acute or chronic) or uncontrolled severe infection, liver disease such as cirrhosis, decompensated liver disease, and active and chronic hepatitis, as determined by the investigator.
- Known active systemic bacterial infection (requiring intravenous [IV] antibiotics or fever >38.5°C at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C [for example, hepatitis B surface antigen positive]. Screening of viral infection is not required for enrollment.
- The participant has a personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest.
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 |
|---|---|---|
| Quisinostata highly potent and orally active HDAC inhibitor | Drug | Newly-Diagnosed WHO Grade 4 Glioblastoma IDH-WT, Recurrent WHO Grade 4 Glioblastoma IDH-WT |
Primary outcome
Quisinostat Concentration in Tumor Tissue
Time frame: Phase 0 surgery
Total and unbound quisinostat concentration will be quantified in Gd-enhancing and Gd-non-enhancing tumor tissue collected during Phase 0 surgery.
6-Month Progression Free Survival (PFS6) Rate in Participants
Time frame: From date of Phase 0 surgery to date of disease recurrence or death, assessed over 16 months
The rate of 6-month progression-free survival of participants that had a positive PK response (defined as unbound concentrations of quisinostat equal or greater than 0.5 nM in Gd-non-enhancing tumor tissue) will be quantified.
7 secondary outcomes
Quisinostat Concentration in Cerebrospinal Fluid (CSF)
Time frame: From date of Phase 0 surgery through study completion, assessed over 4 months
Number of Participants with Drug-Related Toxicity
Time frame: From date of first dose until 30 days after last dose, assessed over 4 months
Number of Treatment-Emergent Adverse Events
Time frame: From date of enrollment until 30 days after last dose, assessed over 6 months
Number of Treatment-Related Adverse Events
Time frame: From date of first dose until 30 days after last dose, assessed over 4 months
Number of Participants with Clinical Laboratory Abnormalities
Time frame: From date of first dose until 30 days after last dose, assessed over 4 months
Number of Serious Adverse Events and Deaths
Time frame: From date of enrollment until 30 days after last dose, assessed over 6 months
Overall Survival during Expansion Phase
Time frame: From date of surgery until death, assessed up to 16 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 17 Mar 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.
Nader Sanai, MD principal investigator
Ivy Brain Tumor Center
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 Quisinostat in people with Glioblastoma WHO Grade IV, run by Nader Sanai 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 13 inclusion and 13 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 17 Mar 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?
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?
Quisinostat Concentration in Tumor Tissue (time frame: Phase 0 surgery). 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 17 Mar 2026.