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)

Description

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.

Trial 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.

Study Info

Interventions

Locations Recruiting

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