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Study of KRT-232 or TL-895 in Janus Associated Kinase Inhibitor Treatment-Naïve Myelofibrosis

Recruiting
18 years of age
Both
Phase 2

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Overview

This study evaluates either KRT-232 or TL-895 in treatment naïve patients with myelofibrosis (MF)

The study will be conducted in 2 stages. Stage 1 will evaluate safety, tolerability, and efficacy of either KRT-232 (Arm 1) or TL-895 (Arm 2) in treatment naïve patients. Stage 2 will expand enrollment in Arm 1 and/or Arm 2 if expansion criteria is met.

Eligibility

Inclusion Criteria:

  • Confirmed diagnosis of PMF, post-PV MF or post-ET MF (WHO)
  • High-risk, or intermediate-1 and 2 risk, defined by Dynamic International Prognostic System (DIPSS)
  • ECOG of 0 or 1

Exclusion Criteria:

  • Subjects who are positive for p53 mutation (Arm 1)
  • Prior MDM2 inhibitor therapy or p53-directed therapy (Arm 1)
  • Prior treatment with any JAK inhibitor
  • Prior splenectomy
  • Splenic irradiation within 24 weeks prior to randomization
  • Prior allogeneic stem-cell transplantation or plans for allogeneic stem-cell transplant
  • History of major organ transplant
  • Grade 2 or higher QTc prolongation
  • Major hemorrhage or intracranial hemorrhage within 24 weeks prior to randomization

Study details

Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (Post-PV-MF), Post-Essential Thrombocythemia Myelofibrosis (Post-ET-MF)

NCT04878003

Kartos Therapeutics, Inc.

26 January 2024

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