Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AZD1390 · 3 trials · 6 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.
To assess if 11C AZD1390 crosses the blood brain barrier in healthy volunteers
| 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) |
| [11C]AZD1390 Microdose | OTHER | \[11C\]AZD1390 single dose not exceeding 10 ug by IV bolus |
| 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) |
| [11C]AZD1390 | DRUG | \[11C\]AZD1390 |
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 being studied for use in oncology. Clinical trials are evaluating it in recurrent glioblastoma multiforme, primary glioblastoma multiforme, brain neoplasms, leptomeningeal disease, and advanced solid malignancies. It is also being studied in healthy volunteer male subjects for microdosing research.
AZD1390 is being developed by AstraZeneca PLC, a biopharmaceutical company traded on the stock exchange under the ticker AZN. AstraZeneca is conducting clinical trials to assess the safety and tolerability of this investigational drug.
AZD1390 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. All studies of AZD1390 are early-stage trials focused on safety, tolerability, and drug metabolism.
AZD1390 is being studied in several Phase 1 trials. NCT03423628 is assessing safety and tolerability with radiation therapy in patients with brain cancer. NCT03215381 is a completed microdose study in healthy volunteers. NCT07643870 is a human ADME study in advanced solid malignancies.
AZD1390 is a small molecule designed to inhibit the ataxia telangiectasia mutated kinase. By targeting this kinase, the drug is being investigated for its potential to enhance the effects of radiation therapy in brain cancers.