AG-270 Clinical Trials

Size	Price	Qty
5mg	USD 370
25mg	USD 970

Clinical Trials

A clinical trial sponsored by Institut de Recherches Internationales Servier evaluated AG-270 in a Phase 1 study targeting advanced solid tumors or lymphoma characterized by homozygous MTAP deletion. Designed to assess safety and preliminary activity in these specific oncology indications, the study was ultimately terminated. Consequently, clinical research on AG-270 remains limited and in an early stage.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03435250	TERMINATED	Advanced Solid Tumors; Lymphoma	Institut de Recherches Internationales Servier	2018-03-04	PHASE1

(data from https://clinicaltrials.gov, updated on 2024-07-25)

Check the AG-270 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

AG-270 functions as a potent, non-competitive inhibitor of methionine adenosyltransferase 2A (MAT2A), thereby suppressing the enzymatic production and reducing intracellular levels of S-adenosylmethionine. This biochemical depletion selectively induces antiproliferative activity in MTAP-null tumor cells, establishing its clinical relevance for treating advanced solid tumors and lymphomas with homozygous MTAP deletion.

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>).