Drugs / LUVIXASERTIB
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT02792465 | Nov 2016 → Jun 2025 | breast cancer | University Health Network, Toronto | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT05251714 | May 2022 → Aug 2026 overdue | breast cancer | Treadwell Therapeutics, Inc | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT03568422 | Feb 2019 → Nov 2022 overdue | breast cancer | Canadian Cancer Trials Group | Active not recruiting | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT05601440 | Jun 2023 → Dec 2027 expected | female breast carcinoma | Canadian Cancer Trials Group | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2023-01-10 | Treadwell Therapeutics, Inc | Regulatory Treadwell Therapeutics Announces Fast Track Designation Granted by the FDA to CFI-402257 for the Treatment of ER+/HER2- Breast Cancer treadwelltx.com ↗
the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to CFI-402257 |
| 2022-12-09 | Treadwell Therapeutics, Inc | Results Treadwell Therapeutics Announces A Presentation at the 2022 SABCS Annual Meeting Featuring a Clinical Trial Update on CFI-402257, a Best-in-Class TTK inhibitor treadwelltx.com ↗ |
| 2021-12-08 | Treadwell Therapeutics, Inc | Results Treadwell Therapeutics Announces A Presentation at the 2021 SABCS Annual Meeting Featuring a Clinical Trial Update on CFI-402257, a Best-in-Class TTK inhibitor treadwelltx.com ↗
In this presentation, CFI-402257 demonstrated a tolerable safety profile at doses up to 168 mg QD and linear pharmacokinetics, with 168 mg as the RP2D. |
| 2021-11-30 | Treadwell Therapeutics, Inc | Regulatory Treadwell Therapeutics Announces US FDA Clearance of IND Application for Phase 2 Study of TTK inhibitor, CFI-402257 treadwelltx.com ↗
Treadwell Therapeutics, a clinical stage biotechnology company developing novel therapeutics for highly aggressive cancers, today announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application to evaluate CFI-402257, an oral, first-in-class inhibitor of Threonine Tyrosine Kinase (TTK, also as MPS1) in advanced solid tumors and breast cancer. |
All press releases naming this drug 6 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | LUVIXASERTIB | ChEMBL registry synonym — accepted as the source's own label CHEMBL4469414 ↗ |
| Known as | CFI-402257 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03568422 ↗ |
| Known as | CPD 24 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4469414 ↗ |
| Action | Inhibit | “blocks TTK protein kinase” NCT02792465 ↗ |
| Modality | Small molecule | — CHEMBL4469414 ↗ |
| Route | Oral | “CFI-402257 capsules will be taken orally, once a day, every day.” NCT02792465 ↗ |
| Target | TTK | “blocks TTK protein kinase” NCT02792465 ↗ |