KRT-232 and TKI Study in Chronic Myeloid Leukemia

• Status: Recruiting
• Trial end date: 2026-06-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kartos Therapeutics, Inc.
• Treatments: Dasatinib

Criteria

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 2 prior TKIs.

• 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 history of T315I mutation.

• Prior treatment with MDM2 antagonist therapies.

• Intolerance to current TKI therapy.