Clinical Trials

Several clinical trials are evaluating Luvixasertib (CFI-402257) as a single agent and in combination with paclitaxel or fulvestrant for advanced solid tumors and therapy-resistant hormone receptor-positive, HER2-negative metastatic breast cancer. Encompassing Phase I dose-escalation and Phase II efficacy protocols, these studies are sponsored by academic cooperative groups and clinical organizations, including the Canadian Cancer Trials Group, University Health Network, and Treadwell Therapeutics, Inc. Current statuses across these protocols range from actively recruiting to active non-recruiting and completed.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05601440 RECRUITING
Breast Cancer
Canadian Cancer Trials Group
 2023-06-13 PHASE2
NCT05251714 ACTIVE_NOT_RECRUITING
Advanced Solid Tumor; Breast Cancer
Treadwell Therapeutics, Inc
 2022-05-27 PHASE1; PHASE2
NCT02792465 COMPLETED
Advanced Solid Cancers; Breast Cancer
University Health Network, Toronto
 2016-11-11 PHASE1
NCT03568422 ACTIVE_NOT_RECRUITING
Breast Cancer
Canadian Cancer Trials Group
 2019-02-05 PHASE1; PHASE2

(data from https://clinicaltrials.gov, updated on 2026-05-07)

Check the Luvixasertib (CFI-402257) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Luvixasertib functions as a potent inhibitor of threonine tyrosine kinase (TTK), disrupting spindle assembly checkpoint signaling and inducing abnormal chromosome segregation during mitosis to promote cancer cell apoptosis. By halting tumor cell-cycle progression and mobilizing immune infiltration within the microenvironment, this targeted inhibition exhibits clinical relevance in suppressing the growth of advanced solid tumors and HER2-negative breast 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>).

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