GlioblastomaEarly Phase 1NCT05182905
AZD1390 in Recurrent and Newly Diagnosed WHO Grade 4 Glioma Patients
A Early Phase 1 study testing AZD1390 in people with Glioblastoma and Glioma, run by Nader Sanai at 1 site in United States.
Trial summary
This is an open-label, single-center Phase 0/1b study that will enroll at least 27 participants with recurrent WHO Grade 4 Glioma requiring re-radiation and approximately 35 participants with newly-diagnosed WHO Grade 4 glioma (nGBM). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma, Glioma, Glioblastoma Multiforme
- What is being tested?
- AZD1390
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteUnited States
- Study dates
- 27 May 2022to 10 Dec 2026
- 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
- 1a. Arm C only: Participants undergoing resection for a suspected newly diagnosed WHO Grade 4 glioma. Participants will also need to have radiation planned as part of the post-surgical treatment plan; OR,
- 1b. Arms A and B only: Participants who have had a prior resection of diagnosed glioma (2021 WHO grade IV), 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.
- 2. Participants must have measurable disease preoperatively, defined as at least 1 contrast-enhancing lesion, with 2 perpendicular measurements of at least 1 cm.
- 3. 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.
- 4. Age ≥18 at time of consent. 5. Have a performance status (PS) of ≤2 on the Eastern Cooperative Oncology (Group (ECOG) scale1.
- 6. Ability to swallow oral medications. 7. Participant has adequate bone marrow and organ function as defined by the following laboratory values (as assessed by the local laboratory for eligibility):
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- Adequate bone marrow function:
- absolute neutrophil count ≥1,500/mcL
- Platelets (at time of surgery) ≥100,000/mcL
- hemoglobin ≥9.0 g/dL Participants may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator. Initial treatment must not begin earlier than the day after the erythrocyte transfusion.
- Adequate hepatic function:
- o total bilirubin ≤1.5 X ULN. Participants with Gilbert's syndrome with a total bilirubin ≤2.0 times ULN and direct bilirubin within normal limits are permitted.
- o AST(SGOT) ≤2.5 X institutional ULN
- o ALT(SGPT) ≤2.5 X institutional ULN
- Adequate pancreatic function:
- o Amylase within normal limits (WNL)
- o Lipase within normal limits (WNL)
- Adequate renal function:
- Serum creatinine ≤1.5 X ULN or estimated creatinine clearance ≥ 60 mL/min (calculated using Institutional standard method) 8. Participants with tumor-induced seizures must be well-controlled on a stable anti-epileptic treatment.
- 9. 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) 10. 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.
- 11. 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.
- 12. 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.
- 13. Agreement to adhere to Lifestyle Considerations (see Section 5.3) throughout study duration.
Who cannot join
- Current use of coumarin-derived anticoagulant for treatment, prophylaxis or otherwise, that cannot be discontinued prior to surgery. Therapy with heparin, low molecular weight heparin (LMWH) or fondaparinux is allowed.
- Pregnancy or lactation.
- Known allergic reactions to components of the AZD1390.
- 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.
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- 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 < 470 msec at baseline and after discussion with the Medical Monitor.
- History of epileptic disorder or any seizure history unrelated to tumor.
- History or presence of myopathy or raised creatine kinase (CK) >5 x upper limit of normal (ULN) on 2 occasions at screening.
- Past medical history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease.
- 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 <30ml/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 ATM kinase inhibitors.
- 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 v5.0) Grade 1 at the time of starting study treatment and patients with chronic Grade 2 unresolved toxicities may be eligible following discussion with the Medical Monitor.
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, Single Center, Clinical Trial With an Expansion Phase of AZD1390 Plus Fractionated Radiotherapy in Recurrent and Newly Diagnosed WHO Grade 4 Glioma Patients
This is an open-label, single-center Phase 0/1b study that will enroll at least 27 participants with recurrent WHO Grade 4 Glioma requiring re-radiation and approximately 35 participants with newly-diagnosed WHO Grade 4 glioma (nGBM). The trial will be composed of a Phase 0 component (subdivided into Arms A - C), and an expansion Phase 1b. Patients with tumors demonstrating a positive PK response in the Phase 0 component of the study will be eligible to graduate to an expansion phase that combines therapeutic dosing of AZD1390 plus standard-of-care fractionated radiotherapy (RT).
- Conditions
- Glioblastoma, Glioma, Glioblastoma Multiforme, Glioma, Malignant
- Being tested
- AZD1390
- Medical subject headings
- Glioblastoma, Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD1390Drug
Phase 0: AZD1390 administered orally daily for 3 days prior to resection
Phase 1b: AZD1390 administered daily for 5 days concurrently with standard of care radiation therapy
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Recurrent Grade 4 Glioma Surgical Cohort Time Escalation | Experimental | Not described Receives: Drug: AZD1390 |
| Arm B: Recurrent Grade 4 Glioma Dose Escalation | Experimental | Not described Receives: Drug: AZD1390 |
| Arm C: Newly-diagnosed Grade 4 Glioma | Experimental | Not described Receives: Drug: AZD1390 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 0: The relative pharmacokinetics (PK) of AZD1390 in tumor tissue from Grade 4 glioma participants treated with AZD1390
For PK analysis, total and unbound AZD1390 concentration in Gd-enhancing and Gd-non-enhancing tumor tissue.
Measured: Phase 0 Intraoperative
Phase 1b: Examine the rate of 6-month progression-free survival glioma participants with demonstrated PK effect.
The rate of 6-month progression-free survival (PFS6) measured from time of surgery to date of recurrence or death, whichever occurs first, will be summarized.
Measured: From the date of Phase 0 surgery to the date of progression
Secondary outcomes (6)
Phase 0: To evaluate the relative pharmacokinetics (PK) of AZD1390 in CSF
AZD1390 level in CSF will be determined.
Measured: Phase 0 Intraoperative
Drug-related toxicity
Incidence of drug-related toxicity
Measured: Through study completion, an average of once a week
Adverse events
Number of adverse events through study completion
Measured: Through study completion, an average of once a week
Deaths
Number and incidence of deaths
Measured: Every 3 months for up to 12 months after completing study treatment
Incidence of clinical laboratory abnormalities per CTCAE
Number of clinical laboratory abnormalities per CTCAE
Measured: Through study completion, an average of once a week
Phase 1b: Overall survival
Median overall survival
Measured: From the date of Phase 0 surgery to the date of death due to any cause
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2022
- Study start27 May 2022
- Primary completion10 Jun 2026 (estimated)
- Study completion10 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies 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
- 97 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nader Sanai
- Sponsor type
- University, hospital or other
- Collaborators
- Barrow Neurological Institute, Ivy Brain Tumor Center, AstraZeneca
- Responsible party
- Sponsor-investigator, Nader Sanai, St. Joseph's Hospital and Medical Center, Phoenix
- Investigators
- Nader Sanai, MD, Principal investigator, Chief Scientific Officer/Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05182905
- Sponsor's protocol ID
- Ivy 2020-10
- Status last verified
- Mar 2026
- First submitted
- 22 Dec 2021
- Last updated
- 9 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 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 0/1b, Single Center, Clinical Trial With an Expansion Phase of AZD1390 Plus Fractionated Radiotherapy in Recurrent and Newly Diagnosed WHO Grade 4 Glioma Patients
- ClinicalTrials.gov ID
- NCT05182905
- Acronym / sponsor ID
- Ivy 2020-10
- Conditions
- Glioblastoma, Glioma, Glioblastoma Multiforme, Glioma, Malignant
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 97 participants (estimated)
- Lead sponsor
- Nader SanaiUniversity, hospital or other
- Collaborators
- Barrow Neurological Institute, Ivy Brain Tumor Center, AstraZeneca
- Study start
- 27 May 2022 (actual)
- Primary completion
- 10 Jun 2026 (estimated)
- Study completion
- 10 Dec 2026 (estimated)
- First posted
- 10 Jan 2022 (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, single-center Phase 0/1b study that will enroll at least 27 participants with recurrent WHO Grade 4 Glioma requiring re-radiation and approximately 35 participants with newly-diagnosed WHO Grade 4 glioma (nGBM). The trial will be composed of a Phase 0 component (subdivided into Arms A - C), and an expansion Phase 1b. Patients with tumors demonstrating a positive PK response in the Phase 0 component of the study will be eligible to graduate to an expansion phase that combines therapeutic dosing of AZD1390 plus standard-of-care fractionated radiotherapy (RT).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A: Recurrent Grade 4 Glioma Surgical Cohort Time Escalation | Experimental | Drug: AZD1390 |
| Arm B: Recurrent Grade 4 Glioma Dose Escalation | Experimental | Drug: AZD1390 |
| Arm C: Newly-diagnosed Grade 4 Glioma | Experimental | Drug: AZD1390 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- 1a. Arm C only: Participants undergoing resection for a suspected newly diagnosed WHO Grade 4 glioma. Participants will also need to have radiation planned as part of the post-surgical treatment plan; OR,
- 1b. Arms A and B only: Participants who have had a prior resection of diagnosed glioma (2021 WHO grade IV), 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.
- 2. Participants must have measurable disease preoperatively, defined as at least 1 contrast-enhancing lesion, with 2 perpendicular measurements of at least 1 cm.
- 3. 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.
- 4. Age ≥18 at time of consent. 5. Have a performance status (PS) of ≤2 on the Eastern Cooperative Oncology (Group (ECOG) scale1.
Key exclusion criteria (20 listed)
- Current use of coumarin-derived anticoagulant for treatment, prophylaxis or otherwise, that cannot be discontinued prior to surgery. Therapy with heparin, low molecular weight heparin (LMWH) or fondaparinux is allowed.
- Pregnancy or lactation.
- Known allergic reactions to components of the AZD1390.
- 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.
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 |
|---|---|---|
| AZD1390Phase 0: AZD1390 administered orally daily for 3 days prior to resection Phase 1b: AZD1390 administered daily for 5 days concurrently with standard of care radiation therapy | Drug | Arm A: Recurrent Grade 4 Glioma Surgical Cohort Time Escalation, Arm B: Recurrent Grade 4 Glioma Dose Escalation, Arm C: Newly-diagnosed Grade 4 Glioma |
Primary outcome
Phase 0: The relative pharmacokinetics (PK) of AZD1390 in tumor tissue from Grade 4 glioma participants treated with AZD1390
Time frame: Phase 0 Intraoperative
For PK analysis, total and unbound AZD1390 concentration in Gd-enhancing and Gd-non-enhancing tumor tissue.
Phase 1b: Examine the rate of 6-month progression-free survival glioma participants with demonstrated PK effect.
Time frame: From the date of Phase 0 surgery to the date of progression
The rate of 6-month progression-free survival (PFS6) measured from time of surgery to date of recurrence or death, whichever occurs first, will be summarized.
6 secondary outcomes
Phase 0: To evaluate the relative pharmacokinetics (PK) of AZD1390 in CSF
Time frame: Phase 0 Intraoperative
Drug-related toxicity
Time frame: Through study completion, an average of once a week
Adverse events
Time frame: Through study completion, an average of once a week
Deaths
Time frame: Every 3 months for up to 12 months after completing study treatment
Incidence of clinical laboratory abnormalities per CTCAE
Time frame: Through study completion, an average of once a week
Phase 1b: Overall survival
Time frame: From the date of Phase 0 surgery to the date of death due to any cause
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 9 Mar 2026.
- Ivy Brain Tumor Center WebsiteLink provided by the sponsor.
- 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
Chief Scientific Officer/Director
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 AZD1390 in people with Glioblastoma and Glioma, 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 23 inclusion and 20 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 9 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?
Phase 0: The relative pharmacokinetics (PK) of AZD1390 in tumor tissue from Grade 4 glioma participants treated with AZD1390 (time frame: Phase 0 Intraoperative). 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 9 Mar 2026.