KRT-232 and TKI Study in Chronic Myeloid Leukemia

Last updated: March 4, 2022
Sponsor: Kartos Therapeutics, Inc.
Overall Status: Active - Recruiting

Phase

1/2

Condition

Chronic Myeloid Leukemia

Leukemia

Platelet Disorders

Treatment

N/A

Clinical Study ID

NCT04835584
KRT-232-117
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 priorTKI.
  • Adults ≥ 18 years of age.
  • ECOG performance status of 0 to 2
  • Adequate hematologic, hepatic, and renal functions

Exclusion

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 Design

Total Participants: 109
Study Start date:
May 07, 2021
Estimated Completion Date:
June 30, 2026

Connect with a study center

  • Princess Margaret Cancer Center

    Toronto, Ontario M5G 2C1
    Canada

    Active - Recruiting

  • Centre Leon Berard

    Lyon, 69008
    France

    Active - Recruiting

  • APHM Hopital de la Timone

    Marseille, 13005
    France

    Active - Recruiting

  • Institut Paoli-Calmettes

    Marseille, 13009
    France

    Active - Recruiting

  • Centre Hospitalier Lyon Sud

    Saint-Genis-Laval, 69310
    France

    Active - Recruiting

  • Policlinico di Milano Ospedale Maggiore | Fondazione IRCCS Ca' Granda

    Milano, MI 20122
    Italy

    Active - Recruiting

  • Azienda Ospedaliero - Universitaria Mater Domini

    Catanzaro, 88100
    Italy

    Active - Recruiting

  • Istituto Romagnolo per lo Studio dei Tumori Dino Amadori

    Meldola FC, 47014
    Italy

    Active - Recruiting

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, 27100
    Italy

    Active - Recruiting

  • Kyungpook National University Hospital

    Daegu,
    Korea, Republic of

    Active - Recruiting

  • Samsung Medical Center

    Seoul, 135-710
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Severance Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Pratia Onkologia Katowice

    Katowice, 40-519
    Poland

    Active - Recruiting

  • National Medical Research Center of Hematology

    Moscow, 125167
    Russian Federation

    Active - Recruiting

  • Almazov National Medical Research Center

    Saint Petersburg, 197341
    Russian Federation

    Active - Recruiting

  • Samara State Medical University

    Samara, 443001
    Russian Federation

    Active - Recruiting

  • Clínica Universidad de Navarra

    Madrid, Navarra 28027
    Spain

    Active - Recruiting

  • Clinica Universidad de Navarra

    Pamplona, Navarra 31008
    Spain

    Active - Recruiting

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Hospital Universitario La Paz

    Madrid, 28046
    Spain

    Active - Recruiting

  • University of Alabama Birmingham

    Birmingham, Alabama 35294
    United States

    Active - Recruiting

  • Georgia Cancer Center at Augusta University

    Augusta, Georgia 30912
    United States

    Active - Recruiting

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania 15232
    United States

    Active - Recruiting

  • Texas Oncology- Sammons CC at Baylor

    Dallas, Texas 75246
    United States

    Active - Recruiting

  • Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Active - Recruiting

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