Go back to trials list
An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of KRT-232 in Combination With TL-895 for the Treatment of Relapsed or Refractory Myelofibrosis and KRT-232 for the Treatment of JAK Inhibitor Intolerant Myelofibrosis.
Description
This study evaluates KRT-232 in Combination With TL-895 for the Treatment of Relapsed or Refractory Myelofibrosis and KRT-232 for the Treatment of JAK Inhibitor Intolerant Myelofibrosis.Cohorts 1 and 2 will undergo dose finding and dose expansion. Eligible patients will be randomly assigned to an open cohort, either Cohort 1 or Cohort 2. Cohort 3 will be conducted as a dose expansion, independent of Cohorts 1 and 2. Cohort 1 will follow a 3+3 dose escalation design to determine the maximum tolerated dose (MTD)/maximum administered dose (MAD) and recommended Phase 2 dose (RP2D) of TL-895 administered QD in combination with KRT-232. A Safety Review Committee (SRC) will review the safety data during the dose escalation to decide on dose escalation and/or exploration of intermediate doses. Cohort 2 will follow a 3+3 dose escalation design to determine the MTD/MAD and recommended RP2D of TL-895 administered BID in combination with KRT-232. An SRC will review the safety data during the dos
Trial Eligibility
Inclusion Criteria: * Confirmed diagnosis of primary MF, post-PV MF, or post-ET MF, (WHO 2016) * ECOG ≤ 2 * Cohort 1 and Cohort 2: R/R following JAK inhibitor treatment * Cohort 3: patients who are intolerant to JAK inhibitor treatment Exclusion Criteria: * Prior treatment with MDM2 inhibitors or p53-directed therapies * Prior treatment with a BCR-ABL, phosphoinositide 3-kinase (PI3k), mammalian target of rapamycin (mTOR), bromodomain and extraterminal domain (BET), histone deacetylase (HDAC), or spleen tyrosine kinase (Syk) inhibitor * Prior splenectomy * Splenic irradiation within 3 months prior to the first dose of study treatment * Clinically significant thrombosis within 3 months of screening * Grade 2 or higher QTc prolongation
Study Info
Organization
Kartos Therapeutics, Inc.
Primary Outcome
Phase 1b - The MTD/MAD and RP2D of TL-895 in combination with KRT-232 in patients with R/R MF (Cohort 1 and Cohort 2)
Interventions
Locations Recruiting
University of Alabama at Birmingham School of Medicine, Division of Hematology and Oncology
United States, Alabama, Birmingham
The Oncology Institute of Hope
United States, California, Whittier
Lake City Cancer Center
United States, Florida, Lake City
Carle Cancer Center
United States, Illinois, Urbana
Columbia University Medical Center
United States, New Jersey, Fort Lee
Interested in joining this trial?
Our dedicated patient navigators are here to support you by reviewing the eligibility criteria to see if you might qualify for this trial.
Get the latest thought leadership on your Myelofibrosis delivered straight to your inbox
Subscribe to the weekly newsletter for news, stories, clinical trial updates, and helpful resources and events with cancer experts.