Clinical Trials

Multiple Phase 1 clinical trials sponsored by Boston Pharmaceuticals have evaluated BOS172722 in combination with paclitaxel for patients with advanced nonhaematologic malignancies. A completed trial within this industry-sponsored program focused on establishing the safety, tolerability, and preliminary clinical efficacy of the compound in advanced solid tumors. Overall, these studies demonstrate the evaluation of MPS1 kinase inhibition as a therapeutic strategy for advanced nonhaematologic cancers.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT03328494 COMPLETED
Advanced Nonhaematologic Malignancies
Boston Pharmaceuticals
2017-10-13 PHASE1
NCT03328494 Completed
Advanced Nonhaematologic Malignancies
Boston Pharmaceuticals
2017-10-13 Phase 1

(data from https://clinicaltrials.gov, updated on 2021-04-15)

Check the BOS172722 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

BOS172722 potently binds to and inhibits monopolar spindle 1 (MPS1) kinase, which disrupts the spindle assembly checkpoint and causes premature mitotic exit with severe chromosome missegregation. The resulting mitotic catastrophe triggers apoptosis in proliferating cancer cells, providing the biological mechanism underlying its investigation for advanced nonhaematologic 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>).

Note: Technical data last updated: Sep 1, 2026.