A Study of TL-895 in Myelofibrosis or Indolent Systemic Mastocytosis
- Conditions
- Myelofibrosis, Indolent Systemic MastocytosisMedDRA version: 20.0Level: PTClassification code: 10028537Term: Myelofibrosis Class: 100000004864MedDRA version: 27.0Level: PTClassification code: 10056452Term: Indolent systemic mastocytosis Class: 10005329Therapeutic area: Diseases [C] - Hemic and Lymphatic Diseases [C15]
- Registration Number
- CTIS2024-514467-26-00
- Lead Sponsor
- Telios Pharma Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 231
Cohorts 1-3: Adults =18 years of age, Cohorts 1-3: Confirmed diagnosis of PMF, post-PV MF, or post-ET MF, as assessed by treating physician according to the World Health Organization (WHO) criteria, Cohorts 1-3: Eastern Cooperative Oncology Group (ECOG) performance status of =2, Cohorts 1-3: Adequate hematologic, hepatic, and renal functions, Cohorts 1-3: 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, Cohort 5: Confirmed diagnosis of ISM as defined by WHO diagnostic criteria based on review of bone marrow biopsy pathology report results, Cohort 5: Subject must have moderate-to-severe symptoms
Cohorts 1-3, 5: Prior treatment with any BTK or BMX inhibitors, Cohorts 1-3: Prior treatment with JAKi within 28 days prior to study treatment, Cohorts 1-3: Prior splenectomy or splenic irradiation within 24 weeks prior to first dose of study treatment, Cohort 5: Prior treatment with Avapritinib, bezuclastinib, or BLU-263/elenestinib, Cohort 5: Diagnosis with another myeloproliferative disorder
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method