A Phase I Study of KRT-232 Alone or in Combination with TL-895 in People with Myelofibrosis

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Full Title

An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of KRT-232 with TL-895 in Subjects with Relapsed/Refractory Myelofibrosis and of KRT-232 in Janus Associated Kinase Inhibitor-Intolerant Myelofibrosis

Purpose

Myelofibrosis is disease that causes scarring of the bone marrow. The purpose of this study is to find the highest dose of the investigational drug TL-895 that can be given with another investigational drug, KRT-832, in patients with myelofibrosis (MF). Some patients will only take KRT-232 while others will receive both.

KRT-232 may cause cancer cells to die and possibly ease the symptoms of MF while helping restore normal blood cell production. TL-895 targets an enzyme that helps control cellular functions, and this targeting action may kill cancer cells and reduce MF symptoms. Both medications are taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have MF that has come back or worsened after previous treatment, post-polycythemia vera MF, or post-essential thrombocythemia MF.
  • At least 4 weeks must pass since the completion of prior treatment (3 weeks since receiving a JAK inhibitor) and receipt of the study therapy.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Raajit Rampal at 646-608-3746.

Protocol

21-155

Phase

I/II

Investigator

Co-Investigators