AMG 337 Clinical Trials

Size	Price	Qty
5mg	USD 147

Clinical Trials

Multiple clinical trials have evaluated AMG 337 across Phase 1, Phase 2, and combined Phase 1/2 studies to assess safety, tolerability, pharmacokinetics, and efficacy in advanced solid tumors, stomach neoplasms, clear cell sarcoma, and gastroesophageal junction adenocarcinomas. Sponsored by entities including Amgen, NantPharma, LLC, and the Eastern Cooperative Oncology Group, completed investigations include a first-in-human study and a trial in Asian subjects with gastric neoplasms. However, several clinical trials evaluating MET-amplified gastric cancers or specific advanced solid tumors were ultimately terminated or withdrawn.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03132155	TERMINATED	Clear Cell Sarcoma	NantPharma, LLC	2018-08-29	PHASE2
NCT03147976	WITHDRAWN	Solid Tumor	NantPharma, LLC	2018-05-02	PHASE2
NCT02016534	TERMINATED	Stomach Neoplasms	Amgen	2014-02	PHASE2
NCT02096666	COMPLETED	Stomach Neoplasms	Amgen	2014-04-15	PHASE1; PHASE2
NCT01253707	COMPLETED	Advanced Malignancy; Advanced Solid Tumors; Cancer; Oncology; Oncology Patients; Tumors	Amgen	2010-12-08	PHASE1
NCT02344810	WITHDRAWN	Adenocarcinoma of the Esophagus; Adenocarcinoma of the Gastroesophageal Junction; Diffuse Adenocarcinoma of the Stomach; Gastrointestinal Cancer; Intestinal Adenocarcinoma of the Stomach; Mixed Adenocarcinoma of the Stomach; Stage IIIA Esophageal Cancer; Stage IIIA Gastric Cancer; Stage IIIB Esophageal Cancer; Stage IIIB Gastric Cancer; Stage IIIC Esophageal Cancer; Stage IIIC Gastric Cancer; Stage IV Esophageal Cancer; Stage IV Gastric Cancer	Eastern Cooperative Oncology Group	2015-03-06	PHASE1; PHASE2
NCT02096666	Completed	Stomach Neoplasms	Amgen	2014-04-15	Phase 1\|Phase 2
NCT02016534	Terminated	Stomach Neoplasms	Amgen	2014-02	Phase 2
NCT01253707	Completed	Advanced Malignancy\|Advanced Solid Tumors\|Cancer\|Oncology\|Oncology Patients\|Tumors	Amgen	2010-12-08	Phase 1

(data from https://clinicaltrials.gov, updated on 2024-05-24)

Check the AMG 337 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

AMG 337 is an oral, ATP-competitive small-molecule inhibitor that selectively binds to the kinase domain of the Met receptor with an IC50 of 1 nM, thereby blocking receptor autophosphorylation and downstream oncogenic signaling cascades. This target inhibition suppresses MET-driven cellular proliferation, survival, and invasive migration, ultimately inhibiting tumor growth in c-Met-dependent cancers such as stomach neoplasms and advanced 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>).