Actively Recruiting
A Phase I, Multicenter Study to Assess the Safety, Tolerability, and Pharmacokinetics of Ascending Doses of AZD1390 in Combination With Radiation Therapy in Patients With Glioblastoma Multiforme and Brain Metastases from Solid Tumors
Led by AstraZeneca · Updated on 2025-12-22
180
Participants Needed
12
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the investigational drug AZD1390 combined with radiation therapy for treating brain tumors, including glioblastoma multiforme and brain metastases from solid tumors. This Phase 1, open-label study is the first to give AZD1390 to patients and aims to test the safety, tolerability, and how the drug is absorbed and processed in the body at increasing doses alongside different radiation therapy regimens. The study has three treatment arms with varying radiation schedules: Arm A uses 35 Gy of intensity-modulated radiation therapy (IMRT) over 2 weeks for recurrent glioblastoma; Arm B, now closed to recruitment, used 30 Gy of whole or partial brain radiation over 2 weeks for brain metastases; and Arm C uses 60 Gy of IMRT over 6 weeks for primary glioblastoma. AZD1390 is given in cycles before, during, and after radiation therapy, with some participants in Arm A undergoing an optional food effect assessment. Participants will undergo assessments including imaging scans every 8 weeks, blood tests to measure drug levels, and monitoring for side effects from treatment start until about 9 months after the last patient begins treatment. Researchers will track dose-limiting toxicities, adverse events, survival, and tumor response using established criteria. The study includes safety monitoring throughout and collects data on how the drug interacts with food in some participants.
CONDITIONS
Brief Title
A Study to Assess the Safety and Tolerability of AZD1390 Given With Radiation Therapy in Patients With Brain Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provision of formalin-fixed paraffin embedded tissue sample from primary or metastatic disease
- Karnofsky Performance Score of 60 or higher
- Histologically proven diagnosis of glioblastoma multiforme (GBM) or brain metastases as specified per arm
- Radiological diagnosis of recurrent, relapsed, or progressive disease according to RANO criteria for Arm A
- Completion of first-line radiation at least 6 months prior to treatment start for Arm A
- Well controlled tumor-induced seizures and willingness to receive anti-epileptic prophylaxis during study drug administration
- Histologically proven solid tumor malignancy with brain lesions for Arm B (closed to recruitment)
- No prior brain radiation to the treatment area for Arm B
- Histologically proven primary GBM with unmethylated MGMT promoter status and IDH1 mutational testing for Arm C
- No history of uncontrolled seizures after surgery for Arm C
- Specific fasting and dietary requirements for optional food effect assessment in Arm A
You will not qualify if you...
- Chemotherapy or investigational drugs within 28 days prior to treatment start, or carmustine/lomustine within 6 weeks for Arms A and C
- Checkpoint inhibitors within 28 days prior to treatment start and other agents within 7 days for Arm B
- History of severe brain injury or stroke
- Inability to undergo sequential MRI evaluations
- History of epileptic disorder or seizures unrelated to tumor
- Treatment with strong CYP3A4 inhibitors or inducers within 2 weeks prior to study drug
- Concurrent use of seizurogenic medications
- History or presence of interstitial lung disease, drug-induced ILD, or radiation pneumonitis requiring steroids
- Severe or uncontrolled medical conditions such as COPD
- Prior pneumotoxic drug treatment within the past year with lung toxicity
- History or presence of myopathy or elevated creatine kinase greater than 5 times upper limit of normal
- Cardiac dysfunction including recent myocardial infarction or unstable angina
- Active severe pulmonary infections (specific to Japan part)
- Unresolved toxicities greater than grade 1 except alopecia
- Prior treatment with ATM inhibitor with concurrent radiation for Arm A and Japan part
- Diabetes or systemic steroid treatment for food effect assessment in Arm A (not applicable in Japan part)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 weeks for Arm A and B; 6 weeks for Arm C
Participants receive AZD1390 in combination with radiation therapy according to their assigned arm. Treatment includes up to 3 cycles of AZD1390 dosing and radiation therapy that varies by arm.
Daily visits for radiation therapy over the treatment period plus dosing visits for AZD1390
Duration - Up to 9 months for Arms A and C; approximately 8 weeks for Arm B
Participants are monitored for safety, tolerability, and response after completion of treatment. Follow-up includes assessments over approximately 9 months for Arms A and C and about 8 weeks for Arm B.
Regular visits approximately every 8 weeks for response assessments starting 4 weeks after radiation therapy
Trial Site Locations
Total: 12 locations
1
Research Site
Boston, Massachusetts, United States, 02114
Actively Recruiting
2
Research Site
Boston, Massachusetts, United States, 02215
Actively Recruiting
3
Research Site
New York, New York, United States, 10065
Actively Recruiting
4
Research Site
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
5
Research Site
Richmond, Virginia, United States, 23298
Actively Recruiting
6
Research Site
Chūōku, Japan, 104-0045
Completed
7
Research Site
Hidaka-shi, Japan, 350-1298
Active, Not Recruiting
8
Research Site
Kyoto, Japan, 606-8507
Active, Not Recruiting
9
Research Site
Cambridge, United Kingdom, CB2 0QQ
Active, Not Recruiting
10
Research Site
Glasgow, United Kingdom, G12 0YN
Completed
11
Research Site
Leeds, United Kingdom, LS9 7TF
Actively Recruiting
12
Research Site
London, United Kingdom, W1T 7HA
Withdrawn
Research Team
A
AstraZeneca Clinical Study Information Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
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