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

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTelios Pharma, Inc.

About this trial

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.

Eligibility criteria

Qualifiers

Treatment with at a stable dose of ruxolitinib prior to study entry

Subjects ≥ 18 years of age and able to provide informed consent.

Confirmed diagnosis of PMF, post-PV MF, or post-ET MF, as assessed by treating physician according to the World Health Organization (WHO) criteria

High-risk, intermediate-2 risk, or intermediate-1 risk, defined by Dynamic International Prognostic System (DIPSS)

Disqualifiers

Prior treatment with any JAKi

Documented disease progression while on ruxolitinib treatment

Prior splenectomy or splenic irradiation within 24 weeks prior to first dose of study treatment

Prior treatment with a BTK or BMX inhibitor

Trial design

Treatments tested in this trial

  • TL-895
  • Ruxolitinib

Treatment groups

70 Participants
are divided into 5 treatment groups

Locations

19
France
CHU Angers49100, Angers France
AP-HM - Hôpital de la Timone13005, Marseille France
CHU de Nice - Hopital L'Archet II06200, Nice France
Hôpital Saint Louis - AP-HP75010, Paris France

Sponsors and collaborators

Telios Pharma, Inc.

Lead sponsor