MRTX1133 Clinical Trials

Size	Price	Qty
5mg	USD 197
25mg	USD 497

Clinical Trials

A clinical trial sponsored by Mirati Therapeutics Inc. evaluated the safety, tolerability, and initial efficacy of MRTX1133 in patients with KRAS G12D-mutated advanced solid tumors, including non-small cell lung cancer, colorectal cancer, and pancreatic adenocarcinoma. However, official records indicate that recruitment for this early-phase investigation has been terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05737706	TERMINATED	Solid Tumor; Advanced Solid Tumor; Non-small Cell Lung Cancer; Colo-rectal Cancer; Pancreatic Adenocarcinoma	Mirati Therapeutics Inc.	2023-03-06	PHASE1

(data from https://clinicaltrials.gov, updated on 2025-04-06)

Check the MRTX1133 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

MRTX1133 selectively and reversibly binds to both active and inactive forms of the mutant KRAS G12D protein, effectively inhibiting oncogenic GTPase signaling and downregulating downstream effector pathways necessary for cell proliferation. By suppressing these key oncogenic signaling cascades, the compound blocks tumor cell survival and drives regression in KRAS G12D-driven malignancies, providing targeted therapeutic rationale for advanced solid tumors such as non-small cell lung cancer, colorectal cancer, and pancreatic adenocarcinoma.

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>).