ASP3026 Clinical Trials

Size	Price	Qty
10mg	USD 147
50mg	USD 470

Clinical Trials

Multiple completed Phase 1 clinical trials sponsored by Astellas Pharma Inc. have evaluated the safety, dosage, and pharmacokinetics of ASP3026 in human subjects. These open-label and dose-escalation studies investigated patients with solid tumors, B-cell lymphoma, and advanced malignancies testing positive for anaplastic lymphoma kinase or proto-oncogene tyrosine-protein kinase ROS.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01401504	Completed	Solid Tumor	Astellas Pharma Inc	2011-05	Phase 1
NCT01284192	Completed	Advanced Malignancies\|Positive for Anaplastic Lymphoma Kinase\|Positive for Proto-Oncogene Tyrosine-Protein Kinase ROS\|Solid Tumor\|B-Cell Lymphoma	Astellas Pharma Inc	2010-12	Phase 1

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

Check the ASP3026 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

ASP3026 acts as a potent and selective inhibitor of anaplastic lymphoma kinase (ALK) with an IC50 of 3.5 nM, effectively blocking downstream oncogenic signaling cascades to impair cancer cell proliferation and induce apoptotic cell death. This targeted disruption of ALK-mediated oncogenic pathways provides the therapeutic basis for suppressing tumor growth in clinical conditions such as ALK-positive solid tumors, advanced malignancies, and B-cell lymphoma.

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>).