RecruitingPhase 1Phase 2NCT04835584

KRT-232 and TKI Study in Chronic Myeloid Leukemia

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)

Sponsor

Kartos Therapeutics, Inc.

Enrollment

109 participants

Start Date

May 7, 2021

Study Type

INTERVENTIONAL

Conditions

Chronic Myeloid Leukemia

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a drug called KRT-232 (an MDM2 inhibitor, which helps reactivate the body's tumor-suppressing protein) in combination with TKI drugs (targeted therapy pills) for people with chronic myeloid leukemia (CML) — a blood and bone marrow cancer — that has stopped responding to or cannot tolerate current TKI treatments. **You may be eligible if...** - You are 18 years or older - You have Ph+ BCR-ABL+ CML (confirmed by genetic testing) in the chronic or accelerated phase - You have a normal TP53 gene (TP53 wild type) - Your CML is resistant to or you cannot tolerate at least one prior TKI drug - Your blood counts and organ function are within acceptable ranges **You may NOT be eligible if...** - You are in the blast phase of CML (most advanced/aggressive form) - You have a T315I mutation (a specific genetic change that makes some TKIs ineffective) - You have previously received an MDM2 inhibitor - You are completely intolerant of TKI therapy (cannot take these drugs at all) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGKRT-232

KRT-232 is an experimental MDM2 inhibitor anticancer drug taken by mouth.

DRUGDasatinib

Dasatinib is a Tyrosine Kinase Inhibitor anticancer drug taken by mouth.

DRUGNilotinib

Nilotinib is an Tyrosine Kinase Inhibitor anticancer drug taken by mouth.

Locations(26)

University of Alabama Birmingham

Birmingham, Alabama, United States

Georgia Cancer Center at Augusta University

Augusta, Georgia, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Texas Oncology- Sammons CC at Baylor

Dallas, Texas, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Princess Margaret Cancer Center

Toronto, Ontario, Canada

Centre Leon Berard

Lyon, France

APHM Hopital de la Timone

Marseille, France

Institut Paoli-Calmettes

Marseille, France

Centre Hospitalier Lyon Sud

Saint-Genis-Laval, France

Policlinico di Milano Ospedale Maggiore | Fondazione IRCCS Ca' Granda

Milan, MI, Italy

Azienda Ospedaliero - Universitaria Mater Domini

Catanzaro, Italy

Istituto Romagnolo per lo Studio dei Tumori Dino Amadori

Meldola FC, Italy

Fondazione IRCCS Policlinico San Matteo

Pavia, Italy

Pratia Onkologia Katowice

Katowice, Poland

National Medical Research Center of Hematology

Moscow, Russia

Almazov National Medical Research Center

Saint Petersburg, Russia

Samara State Medical University

Samara, Russia

Kyungpook National University Hospital

Daegu, South Korea

Samsung Medical Center

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

Severance Hospital

Seoul, South Korea

Clínica Universidad de Navarra

Madrid, Navarre, Spain

Clinica Universidad de Navarra

Pamplona, Navarre, Spain

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Hospital Universitario La Paz

Madrid, Spain

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