KRT-232 and TKI Study in Chronic Myeloid Leukemia

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.

Conditions

Chronic Myeloid Leukemia

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Study Overview

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Study Details

Study 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.

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)

KRT-232 and TKI Study in Chronic Myeloid Leukemia

Condition
Chronic Myeloid Leukemia
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama Birmingham, Birmingham, Alabama, United States, 35294

Augusta

Georgia Cancer Center at Augusta University, Augusta, Georgia, United States, 30912

Pittsburgh

University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States, 15232

Dallas

Texas Oncology- Sammons CC at Baylor, Dallas, Texas, United States, 75246

Milwaukee

Medical College of Wisconsin, Milwaukee, Wisconsin, United States, 53226

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Kartos Therapeutics, Inc.,

Study Record Dates

2026-06-30