BLU-222 Clinical Trials

Size	Price	Qty
5mg	USD 390
25mg	USD 1,170

Clinical Trials

BLU-222 was evaluated in a Phase 1 clinical trial sponsored by Blueprint Medicines Corporation as monotherapy and combination therapy across cyclin E1 (CCNE1)-amplified advanced solid malignancies, including HR-positive/HER2-negative breast, ovarian, endometrial, gastric, and esophageal cancers, as well as carcinosarcoma. Recruitment for this study was terminated, restricting available clinical trial data for BLU-222 to a terminated Phase 1 trial.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05252416	TERMINATED	Advanced Solid Tumors; HR+ Breast Cancer; CCNE1 Amplification; HER2-negative Breast Cancer; Ovarian Cancer; Endometrial Cancer; Gastric Cancer; Esophageal Adenocarcinoma; Carcinosarcoma	Blueprint Medicines Corporation	2022-04-07	PHASE1

(data from https://clinicaltrials.gov, updated on 2025-11-28)

Check the BLU-222 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

BLU-222 functions as a potent and selective small-molecule inhibitor of cyclin-dependent kinase 2 (CDK2), binding the kinase active site to block downstream phosphorylation events and trigger G1/S phase cell-cycle arrest in dependent tumor cells. By suppressing CDK2-driven pathway hyperactivation, this targeted disruption limits cancer cell proliferation, providing therapeutic relevance for inhibiting tumor progression in advanced solid malignancies and CCNE1-amplified breast and ovarian cancers.

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>).