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)

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.

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 therapy.