Clinical Trials

A Phase 1 clinical trial sponsored by AstraZeneca evaluated the investigational oncology agent AZD0156 as both monotherapy and combination therapy in patients with advanced solid tumors. Having completed recruitment, this early-stage study assessed the drug candidate's safety profile, tolerability, pharmacokinetics, and preliminary efficacy. The resulting data provide foundational human trial evidence regarding the therapeutic feasibility and dosing regimens of AZD0156 in advanced cancer indications.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT02588105 COMPLETED
Advanced Solid Tumours
AstraZeneca
2015-11-10 PHASE1

(data from https://clinicaltrials.gov, updated on 2022-09-19)

Check the AZD0156 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

AZD0156 functions as a potent and selective inhibitor of ataxia telangiectasia mutated kinase, binding to the enzyme to block DNA damage checkpoint activation and impair double-strand break repair pathways. This disruption of cellular repair machinery induces tumor cell apoptosis, providing a biological rationale for its clinical evaluation as a chemo- and radio-sensitizing therapeutic agent against advanced solid tumors.

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.