Glumetinib Clinical Trials

Size	Price	Qty
5mg	USD 170
25mg	USD 547

Clinical Trials

Multiple clinical trials evaluate glumetinib across Phase 1 to Phase 3 studies, primarily sponsored by biopharmaceutical companies, with recruitment statuses ranging from active and completed to terminated or not yet recruiting. These investigations evaluate glumetinib as both a monotherapy and in combination regimens to target MET-driven resistance in non-small cell lung cancer harboring MET alterations, advanced gastric or gastroesophageal junction adenocarcinoma, metastatic colorectal cancer, and healthy volunteer cohorts.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06908772	NOT_YET_RECRUITING	Recurrent or Metastatic NSCLC Patients With Classical EGFR Mutations Accompanied by MET Amplification or Overexpression	Shanghai JMT-Bio Inc.	2025-04-01	PHASE2; PHASE3
NCT06980532	RECRUITING	Metastatic Colorectal Cancer	Liu Huang	2025-04-25	PHASE1; PHASE2
NCT06829459	RECRUITING	Non-Small Cell Lung Cancer	Shanghai JMT-Bio Inc.	2025-04-03	PHASE3
NCT06947291	RECRUITING	Advanced Gastric Cancer/Gastroesophageal Junction Adenocarcinoma and Other Solid Tumors	CSPC ZhongQi Pharmaceutical Technology Co., Ltd.	2025-06-04	PHASE2
NCT06525350	NOT_YET_RECRUITING	Locally Advanced/Recurrent or Distant Metastasized Non-small Cell Lung Cancer With MET Overexpression	CSPC ZhongQi Pharmaceutical Technology Co., Ltd.	2024-07	PHASE2
NCT04270591	RECRUITING	C-Met Exon 14 Mutation	Haihe Biopharma Co., Ltd.	2019-07-15	PHASE1; PHASE2
NCT04797702	TERMINATED	Relapsed or Metastatic Non-small Cell Lung Cancer	Shanghai Junshi Bioscience Co., Ltd.	2021-04-21	PHASE1; PHASE2
NCT05507294	COMPLETED	Healthy Volunteers	Haihe Biopharma Co., Ltd.	2021-03-02	PHASE1
NCT04338243	UNKNOWN	Negative T790M Mutation and Met Amplification	Haihe Biopharma Co., Ltd.	2019-11-18	PHASE1; PHASE2
NCT04270591	Recruiting	C-Met Exon 14 Mutation	Haihe Biopharma Co. Ltd.	2019-07-15	Phase 1\|Phase 2

(data from https://clinicaltrials.gov, updated on 2025-04-03)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Glumetinib is a potent and selective ATP-competitive c-Met receptor tyrosine kinase inhibitor that binds to c-Met and blocks autophosphorylation, thereby inhibiting downstream HGF/c-Met signal transduction pathways and preventing cancer cell proliferation, survival, and invasion. By suppressing hyperactivated c-Met signaling, glumetinib induces tumor regression and provides therapeutic efficacy in patients with MET-driven malignancies, such as non-small cell lung cancer with c-Met exon 14 mutations or MET amplification.

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>).