An Open-Label, Multicenter, Phase 2 Study Assessing the Safety and Efficacy of KRT-232 or TL-895 in Janus Associated Kinase Inhibitor Treatment-Naïve Myelofibrosis

Description

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.

Trial 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 Info

Interventions

Locations Recruiting

Interested in joining this trial?

Our dedicated patient navigators are here to guide you through the validation and enrollment process with ease.