A Phase 2 Multicenter Study of TL-895 in Subjects With Relapsed/Refractory Myelofibrosis, Janus Kinase Inhibitor Intolerant Myelofibrosis, Janus Kinase Inhibitor Treatment Ineligible Myelofibrosis, or Indolent Systemic Mastocytosis
Telios Pharma, Inc.
Summary
This study evaluates TL-895, a potent, orally-available and highly selective irreversible tyrosine kinase inhibitor for the treatment of Myelofibrosis (Cohorts 1-3) or Indolent Systemic Mastocytosis (Cohort 5). Participants must be diagnosed with Myelofibrosis and be relapsed/refractory (e.g., having failed prior therapy), intolerant, or ineligible to receive JAKi treatment, or be diagnosed with Indolent Systemic Mastocytosis.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Cohorts 1-3 Key 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 * Eastern Cooperative Oncology Group (ECOG) performance status of ≤2 * Adequate hematologic, hepatic, and renal functions * MF symptoms as defined by having at least 2 symptoms with an average baseline (Day -7 to Day -1) score of at least 1 for each of the 2 symptoms per MFSAF v4.0 * Cohort 3 only: Ineligibility for JAKi treatment with a platelet count of ≥ 25 and \< 50 x 10\^9/L Key…
Interventions
- DrugTL-895
TL-895 is an experimental tyrosine kinase inhibitor drug taken by mouth.
- DrugPlacebo
Placebo to match TL-895
Locations (52)
- University of Colorado - Aurora Cancer CenterAurora, Colorado
- Mayo Clinic - RochesterRochester, Minnesota
- Gabrail Cancer CenterCanton, Ohio
- University of Cincinnati (UC) Physicians Company, LLCCincinnati, Ohio
- Ohio State UniversityColumbus, Ohio
- University of Texas, MD Anderson Cancer CenterHouston, Texas