MRTX0902 Clinical Trials

Size	Price	Qty
5mg	USD 959
25mg	USD 2,877

Clinical Trials

A Phase 1 clinical trial sponsored by Mirati Therapeutics Inc. evaluated MRTX0902 in patients with advanced solid tumors, including non-small cell lung cancer and colorectal cancer. Designed as a multiple expansion cohort study, the trial's recruitment status was officially recorded as terminated. Consequently, clinical evaluation of MRTX0902 under this protocol has been discontinued for these KRAS-driven solid tumor indications.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05578092	TERMINATED	Solid Tumor; Advanced Solid Tumor; Non Small Cell Lung Cancer; Colo-rectal Cancer	Mirati Therapeutics Inc.	2022-12-02	PHASE1

(data from https://clinicaltrials.gov, updated on 2026-02-19)

Check the MRTX0902 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

MRTX0902 selectively binds to Son of Sevenless 1 (SOS1) with an IC50 of 46 nM, preventing its interaction with KRAS and disrupting guanine nucleotide exchange to inhibit downstream MAPK signaling. This suppression of oncogenic signaling arrests cell proliferation and induces cell death in dependent cancer cells, offering therapeutic potential for advanced solid tumors such as non-small cell lung cancer and colorectal 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>).