Clinical Trials

Multiple Phase I clinical trials have evaluated AZD8055 to assess its safety, tolerability, and preliminary pharmacokinetics in patients with recurrent gliomas (including glioblastoma multiforme), advanced hepatocellular carcinoma, lymphomas, and advanced solid malignancies. Sponsored by pharmaceutical entities such as AstraZeneca alongside government organizations like the National Cancer Institute and the National Institutes of Health, these early-phase studies carry recruitment statuses recorded as completed or withdrawn.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT01316809 COMPLETED
Glioblastoma Multiforme; Anaplastic Astrocytoma; Anaplastic Oligodendroglioma; Malignant Glioma; Brainstem Glioma
National Cancer Institute (NCI)
 2011-03-04 PHASE1
NCT00999882 COMPLETED
Cancer; Advanced Hepatocellular Carcinoma
AstraZeneca
 2009-10 PHASE1
NCT01316809 Completed
Glioblastoma Multiforme|Anaplastic Astrocytoma|Anaplastic Oligodendroglioma|Malignant Glioma|Brainstem Glioma
National Cancer Institute (NCI)|National Institutes of Health Clinical Center (CC)
 2011-03-04 Phase 1
NCT00973076 COMPLETED
Cancer; Solid Tumors; Advanced Solid Malignancies
AstraZeneca
 2009-08 PHASE1
NCT00731263 COMPLETED
Solid Tumors
AstraZeneca
 2008-07 PHASE1
NCT00999882 Completed
Cancer|Advanced Hepatocellular Carcinoma
AstraZeneca
 2009-10 Phase 1
NCT00973076 Completed
Cancer|Solid Tumors|Advanced Solid Malignancies
AstraZeneca
 2009-08 Phase 1
NCT00731263 Completed
Solid Tumors
AstraZeneca
 2008-07 Phase 1
NCT01194193 Withdrawn
Cancer|Advanced Solid Tumours|Lymphomas
AstraZeneca
 Phase 1
NCT01194193 WITHDRAWN
Cancer; Advanced Solid Tumours; Lymphomas
AstraZeneca
 PHASE1

(data from https://clinicaltrials.gov, updated on 2019-12-12)

Check the AZD8055 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

AZD8055 functions as a potent, ATP-competitive inhibitor of mTOR kinase that suppresses both mTORC1 and mTORC2 signaling, thereby blocking the phosphorylation of key downstream targets including p70S6K, 4E-BP1, and AKT to halt cap-dependent protein translation, impair cellular proliferation, and trigger both apoptosis and autophagy. By simultaneously disrupting these critical oncogenic survival pathways, AZD8055 achieves tumor growth inhibition across various malignancies under clinical evaluation, such as advanced solid tumors, recurrent gliomas, and hepatocellular carcinoma.

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