KRT-232 and TKI Study in Chronic Myeloid Leukemia

This study is testing a new oral drug called KRT-232, along with existing drugs like Dasatinib or Nilotinib, for people with Chronic Myeloid Leukemia (CML). KRT-232 is an experimental MDM2 inhibitor, which is a type of anticancer drug. This study is for adults whose CML has not responded well to previous treatments with Tyrosine Kinase Inhibitors (TKIs) or who couldn't tolerate them. The researchers want to find the safest and most effective dose of KRT-232 and see how many participants achieve a major molecular response (a significant reduction in leukemia cells) or a major hematological response (improvement in blood counts) within 6 months. The study aims to enroll 109 participants, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive specific treatments. It is a global, open-label Phase 1b/2 study, which means both you and your doctors will know which treatment you are receiving.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The main goals of the study are measured at 28 days for KRT-232 dosing and at 6 months for treatment response.

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NCT04835584

KRT-232 and TKI Study in Chronic Myeloid Leukemia

UNKNOWN
PHASE1Ages 18+InterventionalTreatment
Kartos Therapeutics, Inc.
~109 participants
Updated 2022-03-21 on ClinicalTrials.gov
What's tested:KRT-232DasatinibNilotinib

At a glance

Recruiting sites
26 of 26 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part 1: Maximum tolerated dose (MTD)/maximum administered dose (MAD) of KRT-232
Measured over 28 Days
+2 more outcomes measured
Chronic Myeloid Leukemia
26 sites across 14 states
France4
South Korea4
Italy3
Russia3
Navarre2
Spain2
Alabama1
Georgia1

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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.
  • Part 1: Maximum tolerated dose (MTD)/maximum administered dose (MAD) of KRT-23228 Days

    DLTs will be used to establish the MTD/MAD of KRT-232 in combination with dasatinib or nilotinib

  • Part 2, Arm A and B: Major molecular response (MMR) rate6 months

    The proportion of subjects who achieved complete cytogenetic response (CCyR) or partial cytogenetic response (PCyR) according to modified ELN criteria

  • Part 2, Arm C: Major hematological response (MaHR) rate6 months

    The proportion of subjects who achieved MaHR according to modified ELN criteria