M4205（IDRX-42） Clinical Trials

Size	Price	Qty
5mg	USD 197
25mg	USD 497

Clinical Trials

Multiple clinical trials evaluate M4205 (IDRX-42) for oncological applications, focusing on gastrointestinal neoplasms, particularly metastatic or unresectable gastrointestinal stromal tumors (GIST). A first-in-human Phase I trial sponsored by IDRX, Inc., a subsidiary of GSK, is active but not recruiting to evaluate safety and dosage in metastatic cancer settings. Additionally, a Phase III randomized multicenter study sponsored by GlaxoSmithKline is actively recruiting patients to compare M4205 with sunitinib in advanced GIST.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07218926	RECRUITING	Gastrointestinal Neoplasms	GlaxoSmithKline	2025-12-03	PHASE3
NCT05489237	ACTIVE_NOT_RECRUITING	Gastrointestinal Neoplasms; Gastrointestinal Stromal Tumor (GIST); Digestive System Disease; Gastrointestinal Diseases; Metastatic Cancer	IDRX, Inc., a wholly owned subsidiary of GSK, LLC	2022-08-03	PHASE1

(data from https://clinicaltrials.gov, updated on 2026-06-12)

Check the M4205（IDRX-42） product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

M4205 selectively binds to and inhibits receptor tyrosine kinase KIT, including broad mutant forms across exons 11, 13, and 17, thereby blocking oncogenic downstream signal transduction pathways and suppressing cancer cell proliferation and survival. This targeted enzymatic inhibition translates to dose-dependent tumor regression in preclinical models and underscores its therapeutic evaluation for patients with metastatic and unresectable gastrointestinal stromal 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>).