Luminespib (NVP-AUY922) Clinical Trials

Size	Price	Qty
5mg	USD 160
25mg	USD 470

Clinical Trials

Several Phase 1 and Phase 2 clinical trials have evaluated Luminespib (NVP-AUY922) as both monotherapy and combination therapy for advanced solid tumors, including ALK-rearranged non-small cell lung cancer, HER2-overexpressed or PIK3CA-mutated gastric and esophageal neoplasms, and metastatic pancreatic adenocarcinoma. These studies were sponsored by pharmaceutical leaders such as Novartis and academic institutions including Massachusetts General Hospital and University Health Network Toronto. Recruitment has closed across all trials, with final statuses reported as completed or terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01772797	Completed	Anaplastic Lymphoma Kinase (ALK)\|Non-small Cell Lung Cancer	Novartis Pharmaceuticals\|Novartis	2013-06	Phase 1
NCT01752400	Completed	Non Small Cell Lung Cancer	Massachusetts General Hospital	2013-01	Phase 2
NCT01613950	Completed	Stomach Neoplasms Esophageal Neoplasms Metastatic Gastric Cancer Mutated PI3KCA Protein Overexpressed HER2 Protein	Novartis Pharmaceuticals\|Novartis	2012-12	Phase 1
NCT01484860	Terminated	Adenocarcinoma of the Pancreas\|Metastatic Disease	University Health Network Toronto\|Novartis Pharmaceuticals	2012-01	Phase 2
NCT01402401	Terminated	Advanced Gastric Cancer	Novartis Pharmaceuticals\|Novartis	2011-11	Phase 2

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

Check the Luminespib (NVP-AUY922) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Luminespib (NVP-AUY922) acts by binding to the N-terminal ATP-binding site of HSP90α and HSP90β, thereby inhibiting ATPase activity and disrupting chaperone function needed to stabilize oncogenic client proteins. This targeted inhibition triggers the downregulation of key signaling proteins like IGF-1Rβ, leading to cellular growth arrest, autophagy, and apoptosis, which ultimately suppresses tumor progression in clinical conditions such as non-small cell lung cancer and gastrointestinal 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>).