KRT-232 and TKI Study in Chronic Myeloid Leukemia

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04835584
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1/Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Kartos Therapeutics, Inc.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Canada, France, Italy, Korea, Republic of, Poland, Russian Federation, Spain, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Chronic Myeloid Leukemia

Arms & Interventions

Arms

Experimental: Part 1, KRT-232 combined with TKI (Dasatinib or Nilotinib) in patients with CML-CP

KRT-232 will be administered orally, once daily (QD) on Days 1-7 in a 28-day cycle. TKI (dasatinib or nilotinib) will be administered orally, per locally prescribed dose and schedule.

Experimental: Part 2, Arm A (KRT-232 combined with Dasatinib in patients with CML-CP)

KRT-232 will be administered orally, once daily (QD) on Days 1-7 in a 28-day cycle. Dasastinib will be administered orally, per locally prescribed dose and schedule.

Experimental: Part 2, Arm B (KRT-232 combined with Nilotinib in patients with CML-CP)

KRT-232 will be administered orally, once daily (QD) on Days 1-7 in a 28-day cycle. Nilotinib will be administered orally, per locally prescribed dose and schedule.

Experimental: Part 2, Arm C (KRT-232 combined with Dasatinib or Nilotinib in patients with CML-AP)

KRT-232 will be administered orally, once daily (QD) on Days 1-7 in a 28-day cycle. Dasatinib or Nilotinib will be administered orally, per locally prescribed dose and schedule.

Interventions

Drug: - KRT-232

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

Drug: - Dasatinib

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

Drug: - Nilotinib

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Alabama Birmingham, Birmingham, Alabama

Status

Recruiting

Address

University of Alabama Birmingham

Birmingham, Alabama, 35294

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