Approval Probability
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Also known as [11C]AZD1390, ATM inhibitor
AZD1390 · 2 trials · 5 indications
Amount excreted (Ae) (urine)
Analysis of plasma: Maximum observed concentration (Cmax)
Analysis of urine: Cumulative amount excreted (CumAe)
Analysis of urine: Fraction (percentage) excreted (Fe)
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
For each adverse event CTCAE grade and causality (related to AZD1390 or radiotherapy) will be collected.
| Arm | Type | Description |
|---|---|---|
| AZD1390 | EXPERIMENTAL | Single dose of \[14C\]-AZD1390 |
| Arm A: AZD1390 + Radiation Therapy | EXPERIMENTAL | AZD1390 administration plus 35 Gy of Intensity-modulated radiation therapy (IMRT) administered at daily fractions of 3.5 Gy over 10 fractions (2 weeks) |
| Arm B: AZD1390 + Radiation Therapy | EXPERIMENTAL | 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). |
| Arm C: AZD1390 + Radiation Therapy | EXPERIMENTAL | AZD1390 administration plus 60 Gy of intensity- modulated radiation therapy (IMRT) administered at daily fractions of 2 Gy over 30 fractions (6 weeks) |
| Name | Type | Description |
|---|---|---|
| AZD1390 | DRUG | single dose |
| Radiation Therapy | RADIATION | 35 Gy of Intensity-modulated radiation therapy (IMRT) administered at daily fractions of 3.5 Gy over 10 fractions (2 weeks) |
Inclusion Criteria: * Participants with Histologically or cytologically documented, locally advanced or metastatic solid tumour, excluding lymphoma, no active anticancer treatment, * ECOG performance status of 0 or 1 with no deterioration over the 2 weeks, * Predicted life expectancy ≥ 12 weeks, * ...
AZD1390 is an investigational small molecule developed by AstraZeneca PLC (ticker AZN) as an oncology drug. It is being studied in advanced solid malignancies and recurrent glioblastoma multiforme, and it is designed to be given in combination with radiation therapy in patients with brain cancer.
AZD1390 targets ATM, the ataxia telangiectasia mutated kinase. By acting on ATM, the small molecule is being developed for use alongside radiation therapy in brain cancer and in advanced solid malignancies, where the combination is under study for safety and tolerability.
AstraZeneca PLC, which trades under the ticker AZN, is the developer of AZD1390. The company is running the clinical program for the drug in oncology, including a Phase 1 study of AZD1390 given with radiation therapy in patients with brain cancer.
AZD1390 is in Phase 1 clinical development. It is investigational and is being evaluated in early-stage trials, including a completed Phase 1 study of AZD1390 with radiation therapy in brain cancer and a Phase 1 human ADME study in advanced solid malignancies.
AZD1390 has been studied in NCT03423628, a completed Phase 1 trial of AZD1390 with radiation therapy in patients with brain cancer that enrolled 159 participants across the United States, Japan, and the United Kingdom. A Phase 1 human ADME study, NCT07643870, is also registered in advanced solid malignancies in the United Kingdom.
Yes, [11C]AZD1390 is another name for AZD1390. The carbon-11 label refers to a radiolabeled form used in study settings, and searches for either name refer to the same AstraZeneca investigational ATM-targeting small molecule in Phase 1 development for oncology indications.