MSX-122 Clinical Trials

Size	Price	Qty
5mg	USD 97

Clinical Trials

A Phase I clinical trial sponsored by Metastatix Inc. evaluated the therapeutic potential of MSX-122 in patients with refractory metastatic or locally advanced solid malignancies. This oral dose-escalation study was designed to assess the compound's safety profile and pharmacokinetic properties, though recruitment is currently suspended.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00591682	Suspended	Solid Tumors	Metastatix Inc.	2007-11	Phase 1

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the MSX-122 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

MSX-122 functions as a novel partial antagonist of C-X-C chemokine receptor type 4 (CXCR4) with an IC50 of approximately 10 nM, binding to the receptor to disrupt downstream intracellular signaling cascades and cell migration pathways. By blocking CXCR4-mediated chemotaxis and cell survival signaling, this compound inhibits tumor cell dissemination and survival, providing therapeutic rationale for its investigation in patients with refractory 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>).