AMG 410 Clinical Trials

Size	Price	Qty
1mg	USD 497

Clinical Trials

A Phase 1 clinical trial sponsored by Amgen is actively recruiting patients with KRAS-altered advanced or metastatic solid tumors to evaluate the investigational agent AMG 410. This study assesses the drug as both a monotherapy and in combination with other anti-cancer therapies, focusing on its safety profile, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical efficacy.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07094113	RECRUITING	KRAS Altered Advanced or Metastatic Solid Tumors	Amgen	2025-07-31	PHASE1

(data from https://clinicaltrials.gov, updated on 2026-07-30)

Check the AMG 410 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

AMG 410 is a non-covalent pan-KRAS inhibitor that binds to both GDP- and GTP-bound KRAS forms, thereby blocking downstream oncogenic signaling pathways independently of nucleotide cycling. This inhibition suppresses cellular proliferation in KRAS-mutated and KRAS-amplified tumor cells, demonstrating potential therapeutic utility against KRAS-altered advanced or metastatic 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>).