KRT-232 and TKI Study in Chronic Myeloid Leukemia

Status unconfirmed · Phase 1/Phase 2

Conditions studied: Chronic Myeloid Leukemia

In brief

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.

Key facts

Study ID

NCT04835584

Run by

Kartos Therapeutics, Inc.

People needed

109

Starts

2021-05-07

Expected to finish

2026-06-30

Last updated by the study team

2022-03-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• University of Alabama Birmingham — Birmingham, Alabama, United States (enrolling)
• Georgia Cancer Center at Augusta University — Augusta, Georgia, United States (enrolling)
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States (enrolling)
• Texas Oncology- Sammons CC at Baylor — Dallas, Texas, United States (enrolling)
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States (enrolling)
• Princess Margaret Cancer Center — Toronto, Ontario, Canada (enrolling)
• Centre Leon Berard — Lyon, France (enrolling)
• APHM Hopital de la Timone — Marseille, France (enrolling)
• Institut Paoli-Calmettes — Marseille, France (enrolling)
• Centre Hospitalier Lyon Sud — Saint-Genis-Laval, France (enrolling)
• Policlinico di Milano Ospedale Maggiore | Fondazione IRCCS Ca' Granda — Milan, MI, Italy (enrolling)
• Azienda Ospedaliero - Universitaria Mater Domini — Catanzaro, Italy (enrolling)
• Istituto Romagnolo per lo Studio dei Tumori Dino Amadori — Meldola FC, Italy (enrolling)
• Fondazione IRCCS Policlinico San Matteo — Pavia, Italy (enrolling)
• Pratia Onkologia Katowice — Katowice, Poland (enrolling)
• National Medical Research Center of Hematology — Moscow, Russia (enrolling)
• Almazov National Medical Research Center — Saint Petersburg, Russia (enrolling)
• Samara State Medical University — Samara, Russia (enrolling)
• Kyungpook National University Hospital — Daegu, South Korea (enrolling)
• Samsung Medical Center — Seoul, South Korea (enrolling)
• Seoul National University Hospital — Seoul, South Korea (enrolling)
• Severance Hospital — Seoul, South Korea (enrolling)
• Clínica Universidad de Navarra — Madrid, Navarre, Spain (enrolling)
• Clinica Universidad de Navarra — Pamplona, Navarre, Spain (enrolling)
• Hospital Universitari Vall d'Hebron — Barcelona, Spain (enrolling)

Full record on ClinicalTrials.gov

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