Study of TL-895 in Subjects With Myelofibrosis or Indolent Systemic Mastocytosis

Sponsor: Telios Pharma, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04655118

Patient View

This clinical trial assesses TL-895, an oral tyrosine kinase inhibitor, in adults with Myelofibrosis or Indolent Systemic Mastocytosis. Eligible participants must have a confirmed diagnosis, ECOG status ≤2, and adequate organ function. The study includes a placebo group for comparison. Cohort 3 requires ineligibility for JAKi treatment with specific platelet counts.

Patient Parameters

Program Overview

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 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
  • 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

Exclusion Criteria

  • Prior treatment with any BTK or BMX inhibitors
  • Prior treatment with JAKi within 28 days prior to study treatment
  • Prior splenectomy or splenic irradiation within 24 weeks prior to first dose of study treatment

Cohort 5

Key Inclusion Criteria:

  • Adults ≥18 years of age
  • Confirmed diagnosis of ISM as defined by WHO diagnostic criteria based on review of bone marrow biopsy pathology report results
  • Subject must have moderate-to-severe symptoms

Key Exclusion Criteria:

  • Prior treatment with any BTK or BMX inhibitors
  • Prior treatment with Avapritinib, bezuclastinib, or BLU-263/elenestinib
  • Diagnosis with another myeloproliferative disorder

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