An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of KRT-232 Combined With a Tyrosine Kinase Inhibitor (TKI) in Patients With Relapsed or Refractory Ph+ Chronic Myeloid Leukemia (CML)
Kartos Therapeutics, Inc.
Summary
This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, for the treatment of patients with Ph+ Chronic Myeloid Leukemia (CML) who have relapsed or are refractory or intolerant to a Tyrosine Kinase Inhibitor (TKI). This study is a global, open label Phase 1b/2 to determine the efficacy and safety of KRT-232 in patients with chronic phase CML (CML-CP) and accelerated phase (CML-AP) who have failed TKI treatments.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Phase 1b and Phase 2 Arms A and B: Documented TP53wt, Ph+, BCR-ABL+ CML-CP * Phase 2 Arm C ONLY: Documented TP53wt, Ph+, BCR-ABL+ CML-AP * Subject is resistant (relapsed or refractory) and/or intolerant to at least 1 prior TKI. * Adults ≥ 18 years of age. * ECOG performance status of 0 to 2 * Adequate hematologic, hepatic, and renal functions Exclusion Criteria: * Phase 1b and Phase 2 Arms A and B: Documented Ph+, BCR-ABL+ CML-AP * Documented Ph+, BCR-ABL+ CML-BC * Known T315I mutation. * Prior treatment with MDM2 antagonist therapies. * Intolerance to current TKI ther…
Interventions
- DrugKRT-232
KRT-232 is an experimental MDM2 inhibitor anticancer drug taken by mouth.
- DrugDasatinib
Dasatinib is a Tyrosine Kinase Inhibitor anticancer drug taken by mouth.
- DrugNilotinib
Nilotinib is an Tyrosine Kinase Inhibitor anticancer drug taken by mouth.
Locations (26)
- University of Alabama BirminghamBirmingham, Alabama
- Georgia Cancer Center at Augusta UniversityAugusta, Georgia
- University of Pittsburgh Medical CenterPittsburgh, Pennsylvania
- Texas Oncology- Sammons CC at BaylorDallas, Texas
- Medical College of WisconsinMilwaukee, Wisconsin
- Princess Margaret Cancer CenterToronto, Ontario