Status:
RECRUITING
KRT-232 and TKI Study in Chronic Myeloid Leukemia
Lead Sponsor:
Kartos Therapeutics, Inc.
Conditions:
Chronic Myeloid Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
109 Patients enrolled
Trial Details
Trial ID
NCT04835584
Start Date
May 7 2021
End Date
June 30 2026
Last Update
March 21 2022
Active Locations (26)
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1
University of Alabama Birmingham
Birmingham, Alabama, United States, 35294
2
Georgia Cancer Center at Augusta University
Augusta, Georgia, United States, 30912
3
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15232
4
Texas Oncology- Sammons CC at Baylor
Dallas, Texas, United States, 75246