KRT-232 and TKI Study in Chronic Myeloid Leukemia

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 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.

Conditions2

Locations5 sites

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