Clinical Trials

AZD1390 is being evaluated across several clinical trials ranging from Early Phase 1 through Phase 3 to assess safety, pharmacokinetics, and combination regimens with radiotherapy. These studies target central nervous system malignancies, including glioblastoma and leptomeningeal disease, advanced solid tumors such as non-small cell lung cancer, and healthy volunteers. Led by AstraZeneca in collaboration with academic institutions and research coalitions, trial recruitment statuses currently range from actively recruiting to completed.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT03970447 RECRUITING
Glioblastoma
Global Coalition for Adaptive Research
2019-07-30 PHASE2; PHASE3
NCT05678010 ACTIVE_NOT_RECRUITING
Solid Tumor; Metastatic Solid Tumor; Solid Carcinoma; Solid Tumor, Adult; Metastatic Tumor; Metastatic Cancer
Memorial Sloan Kettering Cancer Center
2023-05-17 PHASE1
NCT07643870 NOT_YET_RECRUITING
Advanced Solid Malignancies
AstraZeneca
2026-06-30 PHASE1
NCT06894979 ACTIVE_NOT_RECRUITING
Childhood Astrocytoma; Childhood Diffuse Intrinsic Pontine Glioma; Childhood Diffuse Midline Glioma; Childhood Glioblastoma; Childhood Malignant Glioma
Children's Oncology Group
2025-06-18 PHASE1
NCT03423628 ACTIVE_NOT_RECRUITING
Recurrent Glioblastoma Multiforme; Primary Glioblastoma Multiforme; Brain Neoplasms, Malignant; Leptomeningeal Disease (LMD)
AstraZeneca
2018-04-02 PHASE1
NCT05182905 ACTIVE_NOT_RECRUITING
Glioblastoma; Glioma; Glioblastoma Multiforme; Glioma, Malignant
Nader Sanai
2022-05-27 EARLY_PHASE1
NCT04550104 RECRUITING
Non Small Cell Lung Cancer
University of Leeds
2021-03-17 PHASE1
NCT05116254 TERMINATED
Soft Tissue Sarcoma Adult
The Netherlands Cancer Institute
2022-07-18 PHASE1
NCT05182905 Recruiting
Glioblastoma|Glioma|Glioblastoma Multiforme|Glioma Malignant
Nader Sanai|Barrow Neurological Institute|Ivy Brain Tumor Center|AstraZeneca|St. Joseph''s Hospital and Medical Center Phoenix
2022-03-09 Early Phase 1
NCT03423628 Recruiting
Recurrent Glioblastoma Multiforme|Primary Glioblastoma Multiforme|Brain Neoplasms Malignant|Leptomeningeal Disease (LMD)
AstraZeneca
2018-04-02 Phase 1
NCT03215381 COMPLETED
Healthy Volunteer Male Subjects
AstraZeneca
2017-10-10 PHASE1
NCT03215381 Completed
Healthy Volunteer Male Subjects
AstraZeneca|Karolinska Institutet Quintiles IMS
2017-10-10 Phase 1

(data from https://clinicaltrials.gov, updated on 2026-07-30)

Check the AZD1390 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

AZD1390 acts as a potent, central nervous system-penetrant inhibitor of ataxia telangiectasia mutated kinase, target-binding to block downstream phosphorylation of key DNA repair signaling proteins and disrupting double-strand break resolution in dividing cancer cells. By compromising DNA damage recovery cascades, this inhibition significantly sensitizes glioblastoma and other solid tumor cells to radiation-induced DNA damage, thereby enhancing radiosensitivity and promoting tumor regression in clinical settings.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

Note: Technical data last updated: Sep 1, 2026.