Skip to content

KRT-232 and TKI Study in Chronic Myeloid Leukemia

Chronic Myeloid Leukemia

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.

null

Participation Requirements

  • Sex:

    ALL

  • Eligible Ages:

    18 and up

Participation 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.

Study Location

Princess Margaret Cancer Center
Princess Margaret Cancer Center
Toronto, Ontario
Canada

Contact Study Team

Study Sponsored By
Kartos Therapeutics, Inc.
Participants Required
More Information
Study ID: NCT04835584