A Phase 1 interventional study of Radiation Therapy and AZD1390 in Recurrent Glioblastoma Multiforme, Primary Glioblastoma Multiforme and Brain Neoplasms, Malignant, sponsored by AstraZeneca. Completed at 11 sites in 3 countries. Open to participants aged 18 Years to 130 Years. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by AstraZeneca · Phase 1, Interventional, and Treatment
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Among 1,302 studies in Glioblastoma with a site in United States — 195 open to participants now, 326 under way, 16 of them phase 3. Glioblastoma · United States.
Among the 1,302 studies in Glioblastoma with a site in United States, this one is the 92nd largest by enrollment of the 1,155 interventional ones that give a count, is one of 71 that started in 2018, is one of 481 in phase 1, and was the 825th registered.
2,135 studies on the registry are indexed under Glioblastoma; 467 are open to participants now.
Browse Glioblastoma studies →195 of the 1,302 studies in Glioblastoma with a site in United States are open now. Recruiting first, the newest first:
Macarena De La Fuente, MD · Sites in United States
Ages 18+
Alpheus Medical, Inc. · Sites in United States
Ages 18–80
Beijing Inno Medicine Co., Ltd. · Sites in United States, China
Ages 18–70
City of Hope Medical Center · Sites in United States
Ages 18+ · Healthy volunteers
Inova Health Care Services · Sites in United States
Ages 18–98
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 339 Glioblastoma studies recruiting now, 234 (69%) set no upper age limit and 65 (19%) stop at 75 or younger; 27 take children under 18; 13 take healthy volunteers.
This study: 18 Years to 130 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
1,302 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 671 · Phase 2 592 · Phase 3 55 · Phase 4 4
First in 1979; this study’s year is marked. 71 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 159 is above the median of 36 across 1,756 interventional studies indexed under Glioblastoma.
Median enrollment 33 across the 1,155 interventional studies, 60 across the 79 observational. Of the 881 that completed or were terminated, 344 (39%) have results posted.
This tab as a report to print or save as PDF → With an account.
321 of 1,302 have an industry lead sponsor. The 10 most frequent:
AstraZeneca is the lead sponsor of 3,503 studies on the registry; 273 are open to participants now.
Of its 369 completed or terminated interventional studies of FDA-regulated products, 178 (48%) have results posted.
AstraZeneca has 7 studies filed under Glioblastoma — fewer than ten, so there is no comparison to draw.
105 of the studies in Glioblastoma with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05271240Phase 3Northwell HealthRepeated Superselective Intraarterial Cerebral Infusion (SIACI) of Bevacizumab With Temozolomide and Radiation Compared to Temozolomide and Radiation Alone in Newly Diagnosed GBM | 2027-04-01 |
| NCT03743662Memorial Sloan Kettering Cancer CenterNivolumab With Radiation Therapy and Bevacizumab for Recurrent MGMT Methylated Glioblastoma | 2026-11 |
| NCT04574856University of Michigan Rogel Cancer CenterMultiparametric MR-Guided High Dose Adaptive Radiotherapy With Concurrent Temozolomide in Patients With Newly Diagnosed Glioblastoma | 2026-11-19 |
| NCT02704858Neonc Technologies, Inc.Safety and Efficacy Study in Recurrent or Progressive Grade III or IV IDH1 Mutated Glioma | 2026-11-30 |
| NCT05781321Mayo ClinicShort Course Radiotherapy for the Treatment of Patients With Glioblastoma, SAGA Study | 2026-11-30 |
Add all 105 to your calendar (.ics) → With an account.
Among the 1,302 studies in Glioblastoma with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This study will test an investigational drug called AZD1390 in combination with radiation therapy for the treatment of brain tumors. This is the first time AZD1390 is being given to patients. This study will test safety, tolerability and PK (how the drug is absorbed, distributed and eliminated) of ascending doses of AZD1390 in combination with distinct regimens of radiation therapy
This first time-in patients (FTIP), open-label, multicentre study of AZD1390 will be conducted in the United States, the United Kingdom and Japan. It consists of three treatment arms: Arm A, B, C. The Japan dose confirmation part (Japan part) is a sub-study of Arm A. Sites from Japan will only participate in the Japan part. This Phase 1 study will assess safety and tolerability of AZD1390 in combination with radiation therapy (RT) in brain malignancies. The combination cohorts have been designed to assess escalating cumulative doses of AZD1390 in settings with 3 different radiation treatment regimens:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Additional Inclusion Criteria Specific for Arm A and Japan:
**Arm B has now closed to recruitment**
Receiving PBRT (rather than WBRT) during Cycle 1 as standard of care for brain metastases
Additional Inclusion criteria for Food Effect Assessment (Arm A):
*Note: the optional food effect assessment is currently open to enrolment*
Exclusion Criteria:
Additional Exclusion criteria for Food Effect Assessment (Arm A) (Not applicable for the Japan Part):
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
AZD1390 administration plus 35 Gy of Intensity-modulated radiation therapy (IMRT) administered at daily fractions of 3.5 Gy over 10 fractions (2 weeks)
Radiation: Radiation Therapy · Drug: AZD1390
AZD1390 administration plus 30 Gy of whole brain radiation therapy (WBRT) or partial brain radiation therapy (PBRT) administered at daily fractions of 3 Gy over 10 fractions (2 weeks).
Radiation: Radiation Therapy · Drug: AZD1390
AZD1390 administration plus 60 Gy of intensity- modulated radiation therapy (IMRT) administered at daily fractions of 2 Gy over 30 fractions (6 weeks)
Radiation: Radiation Therapy · Drug: AZD1390
35 Gy of Intensity-modulated radiation therapy (IMRT) administered at daily fractions of 3.5 Gy over 10 fractions (2 weeks)
Also known as: Radiotherapy, Radiation treatment, RT
AZD1390 Administered in 3 Cycles depending on arm: Cycle 0: 1 dose prior to Radiation Therapy. Cycle 1: 2 weeks Intermittent or continuous dosing during Radiation Therapy. Cycle 2: 2 weeks adjuvant treatment after Radiation Therapy. For optional food effect assessment in Arm A, 2 doses prior to RT under both fed and fasted conditions. Note: the food effect assessment is currently open to recruitment. Arm A includes the Japan part following the same dosing administration.
Also known as: ATM inhibitor
30 Gy of whole brain radiation therapy (WBRT) or partial brain radiation therapy (PBRT) administered at daily fractions of 3 Gy over 10 fractions (2 weeks).
Also known as: Radiotherapy, Radiation treatment, RT
60 Gy of intensity- modulated radiation therapy (IMRT) administered at daily fractions of 2 Gy over 30 fractions (6 weeks)
Also known as: Radiotherapy, Radiation treatment, RT
AZD1390 administered in 1 Cycle. AZD1390 administration concomitantly with RT (2 weeks). Cycle 1 also contains an additional 5 days (post completion of RT with AZD1390 administration). Arm is Closed.
Also known as: ATM inhibitor
AZD1390 Administered in 3 Cycles depending on arm: Cycle 0: 1 dose prior to Radiation Therapy. Cycle 1: 6 weeks Intermittent or continuous dosing during Radiation Therapy. Cycle 2: 2 weeks adjuvant treatment after Radiation Therapy. Arm is closed.
Also known as: ATM inhibitor
Incidence of dose-limiting toxicities (DLTs)
DLTs will be used to calculate the maximum tolerated dose (MTD). In each arm, the MTD of AZD1390 is the highest dose at which the predicted probability of a DLT is less than 25% in that specific RT setting
Time frame: From the start of treatment until the end of the DLT period (approximately 6 weeks for Arm A, 3 weeks for Arm B and 10 weeks for Arm C)
Incidence of adverse events (AEs) and serious adverse events (SAEs)
For each adverse event CTCAE grade and causality (related to AZD1390 or radiotherapy) will be collected.
Time frame: From the start of treatment until the end of the study (approximately 9 months after the last patient has started treatment)
Event free survival (EFS) for Arms A and C only
Defined as the time from the first dose of AZD1390 until the occurrence of any of the following events: 1. Tumor progression or recurrence based on RANO criteria 2. Secondary malignancy 3. Change in tumor treatment due to increase clinical symptoms 4. Death due to any cause
Time frame: From the start of treatment until the patient is off study (approximately 9 months after the last patient has started treatment)
Objective response rate defined by RANO criteria for Arms A and C only
The proportion of patients achieving a complete or partial tumor response (CR or PR) according to RANO criteria.
Time frame: Every 8 weeks starting from 4 weeks after RT until the end of the study (approximately 9 months after the last patient has started treatment)
Objective response rate defined by RANO-BM criteria for Arm B only. **Arm B has now closed to recruitment**
The proportion of patients achieving a complete or partial tumor response (CR or PR) according to RANO-BM criteria.
Time frame: From screening until the patient is off study, approximately 8 weeks
Objective response rate defined by RECIST 1.1 criteria for Arm B only. **Arm B has now closed to recruitment**
The proportion of patients achieving a complete or partial tumor response (CR or PR) according to RECIST 1.1 criteria.
Time frame: From screening until the patient is off study, approximately 8 weeks
Maximum Observed Plasma Concentration (Cmax) of AZD1390
Blood samples will be collected to assess plasma concentrations of AZD1390 at a series of timepoints to derive Cmax
Time frame: At predefined intervals throughout the AZD1390 treatment period (approximately 5 weeks for Arm A, 2 weeks for Arm B and 9 weeks for Arm C)
Time to observed Cmax (Tmax) for AZD1390
Blood samples will be collected to assess plasma concentrations of AZD1390 at a series of timepoints to derive Tmax
Time frame: At predefined intervals throughout the AZD1390 treatment period (approximately 5 weeks for Arm A, 2 weeks for Arm B and 9 weeks for Arm C)
Area under the plasma concentration-time curve (AUC) for AZD1390
Blood samples will be collected to assess plasma concentrations of AZD1390 at a series of timepoints to derive AUC
Time frame: At predefined intervals throughout the AZD1390 treatment period (approximately 5 weeks for Arm A, 2 weeks for Arm B and 9 weeks for Arm C)
Overall survival for Arms A and C only
Defined as the time from the first dose of AZD1390 until death from any cause
Time frame: From start of treatment until the patient dies, withdraws or the end of study is reached (approximately 9 months after the last patient has started treatment)
Assessment of the food effect of AZD1390 at the MTD for Arm A (if conducted)
Blood samples will be collected to assess plasma concentrations of AZD1390 at a series of timepoints under fed and fasted conditions to derive Cmax, Tmax, and AUC
Time frame: At two predefined intervals during cycle 0 (at least 5 days apart)
Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Data sharing details ↗ · astrazenecagroup-dt.pharmacm.com
No publications or documents are linked to this record.
Ran from Apr 2018 to primary completion in Aug 2026, 100 months.
Of 82 industry-sponsored phase 1 interventional studies under Glioblastoma, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 64. This study's 100 months is above that.
Counting every sponsor, half of 322 studies reached it within 44 months; a quarter within 29 and three quarters within 73.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 15, 2026: primary completion Sep 2026 → Aug 2026 and completion Sep 2026 → Aug 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: AZD1390