KRT-232 and TKI Study in Chronic Myeloid Leukemia
ConditionChronic Myeloid Leukemia
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorKartos Therapeutics, Inc.
About this trial
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
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- KRT-232
- Dasatinib
- Nilotinib
Treatment groups
109 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov