Gartisertib (M4344, VX-803) Clinical Trials

Size	Price	Qty
5mg	USD 470
25mg	USD 1,390

Clinical Trials

Multiple clinical trials evaluate gartisertib (M4344, VX-803) across Phase 1 and Phase 1/2 protocols for recurrent ovarian cancer, advanced solid tumors, and breast cancer. Supported by academic sponsors like the University of Alabama at Birmingham and industry partners including EMD Serono and Merck KGaA, these investigations include both completed and withdrawn protocols. Specifically, a clinical trial evaluating gartisertib monotherapy and combination safety, pharmacokinetics, and pharmacodynamics has reached completion, whereas early-phase combination studies with PARP inhibitors are listed as withdrawn.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04149145	WITHDRAWN	Ovarian Cancer Recurrent	University of Alabama at Birmingham	2023-05	PHASE1
NCT04655183	WITHDRAWN	Advanced Solid Tumor; Breast Cancer	EMD Serono Research & Development Institute, Inc.	2020-12-01	PHASE1; PHASE2
NCT04149145	Withdrawn	Ovarian Cancer Recurrent	University of Alabama at Birmingham	2023-05	Phase 1
NCT02278250	COMPLETED	Solid Tumor; Advanced Solid Tumor	EMD Serono Research & Development Institute, Inc.	2015-01-26	PHASE1
NCT04655183	Withdrawn	Advanced Solid Tumor\|Breast Cancer	EMD Serono Research & Development Institute Inc.\|Merck KGaA Darmstadt Germany\|EMD Serono	2020-12-01	Phase 1\|Phase 2

(data from https://clinicaltrials.gov, updated on 2026-06-05)

Check the Gartisertib (M4344, VX-803) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Gartisertib (M4344) selectively binds to the ATP-binding site of ataxia telangiectasia and Rad3-related (ATR) kinase, suppressing downstream phosphorylation of checkpoint kinase-1 (P-Chk1) and impairing DNA damage repair. This inhibition leads to cell cycle checkpoint failure, accumulation of double-strand DNA breaks, and selective apoptosis, which underpins its therapeutic application in clinical trials for advanced solid tumors, breast cancer, and recurrent ovarian cancer.

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>).