Study on TL-895 for Treating Myelofibrosis or Indolent Systemic Mastocytosis

Sponsor: Telios Pharma, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04655118

Provider View

This clinical trial is testing a new oral medication, TL-895, to see if it can help treat people with Myelofibrosis or Indolent Systemic Mastocytosis. Participants must have Myelofibrosis that hasn't responded to other treatments or can't take JAKi treatment, or have Indolent Systemic Mastocytosis.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the effectiveness of TL-895, a new oral medication, in treating Myelofibrosis or Indolent Systemic Mastocytosis. TL-895 is a type of drug known as a tyrosine kinase inhibitor, which works by blocking certain proteins that help cancer cells grow. Participants in the study will either have Myelofibrosis that hasn't responded to previous treatments or can't take JAKi treatment, or they will have Indolent Systemic Mastocytosis.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of Myelofibrosis (PMF, post-PV MF, or post-ET MF) according to medical guidelines.
  • Be in good general health with an ECOG performance status of 0, 1, or 2, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have adequate blood, liver, and kidney function.
  • Experience at least two symptoms of Myelofibrosis with a certain severity level.
  • For Cohort 3: Cannot take JAKi treatment and have a specific platelet count.

For Cohort 5:

  • Must be 18 years or older.
  • Have a confirmed diagnosis of Indolent Systemic Mastocytosis based on medical criteria.
  • Have moderate-to-severe symptoms.

Exclusion Criteria

  • Have previously been treated with BTK or BMX inhibitors.
  • Have taken JAKi treatment within 28 days before starting the study.
  • Have had spleen surgery or radiation to the spleen within 24 weeks before starting the study.

For Cohort 5:

  • Have previously been treated with BTK or BMX inhibitors.
  • Have taken Avapritinib, bezuclastinib, or BLU-263/elenestinib.
  • Have another type of myeloproliferative disorder.

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