NCT05280509

Study of TL-895 Combined With Ruxolitinib in JAKi Treatment-Naïve MF Subjects and Subjects With MF Who Have a Suboptimal Response to Ruxolitinib

An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of TL-895 Combined With Ruxolitinib in Janus-associated Kinase Inhibitor (JAKi) Treatment-Naïve Myelofibrosis (MF) Subjects and Subjects With MF Who Have a Suboptimal Response to Ruxolitinib

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Telios Pharma, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates TL-895, a potent, orally-available and highly selective irreversible tyrosine kinase inhibitor for the treatment of Myelofibrosis. Participants must have MF (PMF, Post PV MF, or Post ET MF) who are JAKi treatment-naïve or those who have a suboptimal response to ruxolitinib.

Conditions

• Myelofibrosis
• Primary Myelofibrosis
• Post-PV MF
• Post-ET Myelofibrosis

Interventions

Type	Name	Description
DRUG	TL-895	TL-895 is an experimental tyrosine kinase inhibitor anticancer drug taken by mouth.
DRUG	Ruxolitinib	Ruxolitinib is an FDA-approved janus kinase inhibitor anticancer drug taken by mouth.

Timeline

• Start date: 2022-06-09
• Primary completion: 2025-10-01
• Completion: 2027-04-01
• First posted: 2022-03-15
• Last updated: 2023-02-21

Locations

19 sites across 6 countries: United States, France, Germany, Italy, Poland, Spain

Regulatory

• FDA-regulated drug study