Phase 1b/2 Study of TL-895 Combined With Ruxolitinib in JAKi Treatment-Naïve MF Subjects and Subjects With MF Who Have a Suboptimal Response to Ruxolitinib

• Status: Not yet recruiting
• Trial end date: 2027-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Telios Pharma, Inc.

Criteria

Inclusion Criteria:

Subjects with suboptimal response to ruxolitinib:

• 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)

• Palpable spleen measuring ≥ 5 cm below the left lower coastal margin (LLCM) or spleen volume of ≥ 450 cm3 by MRI or CT scan assessment

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2

• Adequate hematological, hepatic, & renal function.

Exclusion Criteria:

Treatment-naive subjects:

• Prior treatment with any JAKi

Subjects with suboptimal response to ruxolitinib:

• Documented disease progression while on ruxolitinib treatment

All subjects:

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

• Prior treatment with a BTK or BMX inhibitor