KRT-232 and TKI Study in Chronic Myeloid Leukemia

Sponsor: Kartos Therapeutics, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04835584

Patient View

This global, open-label Phase 1b/2 study assesses the efficacy and safety of KRT-232, an oral MDM2 inhibitor, in adults with TP53wt, Ph+, BCR-ABL+ CML-CP or CML-AP, who are resistant or intolerant to at least one TKI. Participants must have an ECOG status of 0-2 and adequate organ function. Interventions include KRT-232, Dasatinib, and Nilotinib.

Patient Parameters

Program Overview

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 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 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.

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