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.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
KRT-232 and TKI Study in Chronic Myeloid Leukemia
At a glance
Conditions
Where it's being run
26 sites across 14 statesWho to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Inclusion
Exclusion
What this trial measures
- 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