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)
Mechanism and Biochemical Profile
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>).
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- AZD1390 Stock Solution
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- AZD1390 Combination Database
- AZD1390 Molecular Weight
- AZD1390 SMILES
- AZD1390 CAS Number
- AZD1390 Chemical Structure (2D and 3D)
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