Principal Investigator: Yan Ji, MD
Study Sponsor: Kartos Therapeutics, Inc.
Location: Regions Cancer Care Center
Phase of Study: Phase 2
Purpose of Study: In this study, we want to find out how well a drug called KRT-232 is tolerated when given to patients with (myelofibrosis) MF and whether KRT-232 can improve your MF. KRT-232 (previously called AMG 232) is investigational and is not approved by the U.S. Food and Drug Administration (FDA). This is the first study of KRT-232 in MF and it will evaluate how well tolerated KRT-232 is when given to participants with MF, and whether KRT-232 can improve your MF. KRT-232 has been given to about 170 participants with different cancers and disorders (other than MF). Some of these studies are ongoing. KRT-232 is a small molecule inhibitor and can reverse a mechanism through which unhealthy or tumor cells can survive and grow. This study will test if KRT-232 can restore the function of your healthy bone marrow cells and reduce the symptoms of your MF. This study will test different doses and schedules of KRT-232 in 3 groups of participants to identify the recommended dose and schedule.
-Confirmed diagnosis of PMF, post-PV MF or post-ET MF (WHO)
-High, intermediate-2, or intermediate-1 risk Dynamic International Prognostic System (DIPSS)
-Failure of prior treatment with JAK inhibitor (Part A) or ruxolitinib (Part B)
-ECOG ≤ 2
-Splenic irradiation within 3 months prior to the first dose of KRT-232
-Active or chronic bleeding within 4 weeks prior to the first dose of KRT-232
-Prior MDM2 inhibitor therapy or p53-directed therapy
-Prior treatment with HDAC or BCL-2 inhibitors
-Grade 2 or higher QTc prolongation (> 480 milliseconds per NCI-CTCAE criteria, version 5.0)
Lisa Wahowske, RN, BSN, OCN