Bemcentinib (R428) Clinical Trials

Size	Price	Qty
1mg	USD 147
5mg	USD 277

Clinical Trials

Multiple clinical trials spanning Phase 1, Phase 2, and Phase 3 evaluate bemcentinib as monotherapy and combination therapy across several oncology indications, including non-small cell lung cancer, acute myeloid leukemia, myelodysplastic syndromes, malignant mesothelioma, and pancreatic cancer. Sponsored by biotechnology firms such as BerGenBio ASA alongside academic institutions like the University of Texas Southwestern Medical Center and the University of Leicester, these protocols display varying recruitment statuses ranging from completed to recruiting or terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07445048	RECRUITING	Head & Neck Squamous Cell Carcinoma; Head & Neck Cancer; Postoperative Adjuvant Treatment	Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University	2026-03-04	PHASE3
NCT06516887	TERMINATED	Advanced Lung Adenocarcinoma	The University of Texas Health Science Center at San Antonio	2024-12-27	PHASE1; PHASE2
NCT05469178	TERMINATED	Carcinoma, Non-Small-Cell Lung	BerGenBio ASA	2023-03-03	PHASE1; PHASE2
NCT03654833	COMPLETED	Mesothelioma, Malignant	University of Leicester	2019-01-28	PHASE2
NCT03184571	COMPLETED	Lung Cancer Metastatic; NSCLC Stage IV; Adenocarcinoma of Lung	BerGenBio ASA	2017-10-02	PHASE2
NCT06469138	COMPLETED	Non-Small Cell Lung Cancer; Metastatic Melanoma; Acute Myeloid Leukemia; Myelodysplastic Syndromes; Metastatic Pancreatic Cancer; Glioblastoma; Malignant Mesothelioma; COVID-19	BerGenBio ASA	2022-08-02	PHASE1
NCT03649321	TERMINATED	Cancer of Pancreas	University of Texas Southwestern Medical Center	2019-01-03	PHASE1; PHASE2
NCT02488408	COMPLETED	Acute Myeloid Leukemia; Myelodysplastic Syndromes	BerGenBio ASA	2014-10-22	PHASE1; PHASE2
NCT02424617	COMPLETED	Non-Small Cell Lung Cancer	BerGenBio ASA	2015-04-19	PHASE1; PHASE2
NCT04890509	COMPLETED	COVID-19	BerGenBio ASA	2020-10-20	PHASE2
NCT03824080	COMPLETED	Acute Myeloid Leukemia; High-risk Myelodysplastic Syndrome; Low-risk Myelodysplastic Syndrome	GWT-TUD GmbH	2018-12-20	PHASE2
NCT03824080	Completed	Acute Myeloid Leukemia\|High-risk Myelodysplastic Syndrome\|Low-risk Myelodysplastic Syndrome	GWT-TUD GmbH\|Groupe Francophone des Myelodysplasies\|Amsterdam UMC location VUmc\|BerGenBio ASA	2018-12-20	Phase 2
NCT03184558	TERMINATED	Triple Negative Breast Cancer; Inflammatory Breast Cancer Stage IV	BerGenBio ASA	2017-07-26	PHASE2
NCT02922777	Completed	Non-Small Cell Lung Carcinoma	University of Texas Southwestern Medical Center\|Texas Tech University Health Sciences Center\|BerGenBio ASA	2016-11	Phase 1
NCT02424617	Completed	Non-Small Cell Lung Cancer	BerGenBio ASA	2015-03	Phase 1\|Phase 2
NCT02488408	Unknown status	Acute Myeloid Leukemia\|Myelodysplastic Syndromes	BerGenBio ASA	2014-09	Phase 1\|Phase 2

(data from https://clinicaltrials.gov, updated on 2026-04-17)

Check the Bemcentinib (R428) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Bemcentinib selectively binds to the Axl receptor tyrosine kinase with high affinity, blocking ligand-induced receptor autophosphorylation and suppressing downstream oncogenic signaling cascades responsible for cell survival and epithelial-to-mesenchymal transition. This pathway inhibition reduces tumor proliferation and survival, providing a strong rationale for its ongoing clinical evaluation in malignancies such as non-small cell lung cancer and acute myeloid leukemia.

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>).