AZD0364 (ATG-017) Clinical Trials

Size	Price	Qty
2mg	USD 170
5mg	USD 347

Clinical Trials

The clinical evaluation of AZD0364 (ATG-017) involves a clinical trial sponsored by Antengene Therapeutics Limited to assess the drug's safety, pharmacokinetics, and preliminary efficacy as a monotherapy or combination therapy. This open-label, multi-center, early-phase study focused on patients with advanced solid tumors and hematological malignancies. Currently, the recruitment status for this trial is officially listed as terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04305249	TERMINATED	Solid Tumor; Hematological Malignancy	Antengene Therapeutics Limited	2020-08-15	PHASE1

(data from https://clinicaltrials.gov, updated on 2024-07-23)

Check the AZD0364 (ATG-017) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

AZD0364 (ATG-017) acts as a potent inhibitor of extracellular signal-regulated kinase 1 and 2 (ERK1/2), exhibiting an IC50 value of 0.6 nM against ERK2, thereby blocking downstream phosphorylation events within the MAPK/ERK signaling cascade. By suppressing these critical oncogenic signaling pathways, the compound inhibits tumor cell proliferation and survival, offering therapeutic potential in the context of solid tumors and hematological malignancies.

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>).