Study of TL-895 in Subjects With Myelofibrosis

• Status: Recruiting
• Trial end date: 2024-06-30
• 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 be relapsed/refractory (e.g., having failed prior therapy), intolerant, or ineligible to receive JAKi treatment.

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

Details

• Lead Sponsor: Telios Pharma, Inc.

Criteria

Inclusion Criteria:

• Adults ≥18 years of age

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

• Palpable spleen measuring ≥5 cm below the LLCM or spleen volume of ≥450 cm3 by MRI or CT scan assessment

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

• Adequate hematologic, hepatic, and renal functions

Exclusion Criteria:

• Prior treatment with any BCR-ABL, phosphoinositide 3-kinase (PI3K), mammalian target of rapamycin (mTOR), bromodomain and extraterminal domain (BET) or spleen tyrosine kinase (Syk) inhibitors

• Cohorts 1 and 2 - Prior treatment with JAKi within 21 days of the Screening MRI/CT scan. Subjects in Cohort 3 must not have received JAKi

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