KRT-232 and TKI Study in Chronic Myeloid Leukemia
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.
109 participants
May 7, 2021
INTERVENTIONAL
Conditions
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
Inclusion Criteria6
- 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 Criteria5
- 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 therapy.
Interventions
KRT-232 is an experimental MDM2 inhibitor anticancer drug taken by mouth.
Dasatinib is a Tyrosine Kinase Inhibitor anticancer drug taken by mouth.
Nilotinib is an Tyrosine Kinase Inhibitor anticancer drug taken by mouth.
Locations(26)
View Full Details on ClinicalTrials.gov
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NCT04835584