AMG-208 Clinical Trials

Size	Price	Qty
10mg	USD 320

Clinical Trials

A phase 1 clinical trial sponsored by Amgen evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamics of AMG-208, a targeted c-Met inhibitor, in adult subjects with advanced solid tumors and malignancies. This completed study represents the initial clinical evaluation characterizing the safety and pharmacological profile of the compound for oncology applications.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00813384	Completed	Cancer\|Oncology\|Tumors\|Advanced Malignancy\|Advanced Solid Tumors\|Oncology Patients	Amgen	2008-12	Phase 1

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

Check the AMG-208 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

AMG-208 functions as a potent small-molecule inhibitor that selectively binds to c-Met and RON receptor tyrosine kinases, blocking receptor autophosphorylation and suppressing downstream oncogenic signaling pathways necessary for cellular proliferation and survival. By inhibiting both ligand-dependent and ligand-independent c-Met activation to disrupt tumor cell growth, this agent demonstrates therapeutic relevance for targeted intervention in advanced solid tumors and malignancies.

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>).