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An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of KRT-232 Combined With Ruxolitinib in Patients With Primary Myelofibrosis (PMF), Post-Polycythemia Vera MF (Post-PV-MF), Or Post-Essential Thrombocythemia MF (Post ET-MF) Who Have a Suboptimal Response to Ruxolitinib
Description
This is a phase 1b/2 study of KRT-232 combined with ruxolitinib in subjects with MF who have a suboptimal response after at least 18 weeks of treatment with ruxolitinib. The primary objective of the study is to determine a recommended phase 2 dose (RP2D) of KRT 232 in combination with ruxolitinib.
Trial Eligibility
Inclusion Criteria: * Confirmed diagnosis of PMF, post-PV MF, or post-ET MF, as assessed by treating physician according to the World Health Organization (WHO) * Treatment with ruxolitinib for ≥18 weeks prior to study entry, and on a stable dose of ruxolitinib in the 8 weeks prior to study entry * Spleen ≥5 cm palpable below the LLCM or ≥450 cm3 by MRI or CT * Patients must have at least 2 symptoms with a score of at least 1 on the MFSAF v4.0 * ECOG performance status of 0 to 2 Exclusion Criteria: * Patients who are positive for TP53 mutations * Documented disease progression or clinical deterioration any time while on ruxolitinib treatment * Patients who have had a documented spleen response to ruxolitinib. * Prior splenectomy * Prior MDM2 inhibitor therapy or p53-directed therapy
Study Info
Organization
Kartos Therapeutics, Inc.
Primary Outcome
For Phase 1: To determine the KRT-232 RP2D in combination with ruxolitinib
Interventions
Locations Recruiting
City of Hope
United States, California, Duarte
John Hopkins University
United States, Maryland, Baltimore
University of Michigan
United States, Michigan, Ann Arbor
Icahn School of Medicine at Mount Sinai
United States, New York, New York
Cleveland Clinic
United States, Ohio, Cleveland
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