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

Description

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.

Conditions

Myelofibrosis, Indolent Systemic Mastocytosis

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Study Overview

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Study Details

Study 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.

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

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

Condition
Myelofibrosis
Intervention / Treatment

-

Contacts and Locations

Aurora

University of Colorado - Aurora Cancer Center, Aurora, Colorado, United States, 80045

Rochester

Mayo Clinic - Rochester, Rochester, Minnesota, United States, 55905

Canton

Gabrail Cancer Center, Canton, Ohio, United States, 44718

Cincinnati

University of Cincinnati (UC) Physicians Company, LLC, Cincinnati, Ohio, United States, 45267

Columbus

Ohio State University, Columbus, Ohio, United States, 43210

Houston

University of Texas, MD Anderson Cancer Center, Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Telios Pharma, Inc.,

Study Record Dates

2025-12-31