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MDM2 Inhibitor
KRT-232 + TKI for Chronic Myeloid Leukemia
Phase 1 & 2
Recruiting
Research Sponsored by Kartos Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject is resistant (relapsed or refractory) and/or intolerant to at least 1 prior TKI.
Adults ≥ 18 years of age.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 47 months
Awards & highlights
Study Summary
This trial is looking at a new drug, KRT-232, to see if it is effective in treating patients with a certain type of leukemia who have not responded well to other treatments.
Who is the study for?
This trial is for adults over 18 with Chronic Myeloid Leukemia who have not responded well to or cannot tolerate Tyrosine Kinase Inhibitor treatments. They must be in the chronic phase (CML-CP) or accelerated phase (CML-AP), without a specific mutation (T315I), and their body should be functioning well enough to participate.Check my eligibility
What is being tested?
The study tests KRT-232, a new inhibitor targeting MDM2, in combination with existing drugs Dasatinib or Nilotinib, for patients whose leukemia has resisted previous treatments. It's an open-label trial meaning everyone knows what treatment they're getting.See study design
What are the potential side effects?
Potential side effects include issues affecting blood cells leading to increased infection risk, bleeding problems, fatigue; liver and kidney function changes; gastrointestinal symptoms like nausea and vomiting; and possible skin reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had a cancer treatment that didn't work or I couldn't tolerate it.
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I am 18 years old or older.
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I can care for myself and am up and about more than 50% of my waking hours.
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My leukemia is TP53 wild-type, Ph+, and BCR-ABL+.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 47 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~47 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Part 1: Maximum tolerated dose (MTD)/maximum administered dose (MAD) of KRT-232
Part 2, Arm A and B: Major molecular response (MMR) rate
Part 2, Arm C: Major hematological response (MaHR) rate
Secondary outcome measures
CCyR rate
Duration of response
MCyR rate
+3 moreTrial Design
4Treatment groups
Experimental Treatment
Group I: Part 2, Arm C (KRT-232 combined with Dasatinib or Nilotinib in patients with CML-AP)Experimental Treatment3 Interventions
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.
Group II: Part 2, Arm B (KRT-232 combined with Nilotinib in patients with CML-CP)Experimental Treatment2 Interventions
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.
Group III: Part 2, Arm A (KRT-232 combined with Dasatinib in patients with CML-CP)Experimental Treatment2 Interventions
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.
Group IV: Part 1, KRT-232 combined with TKI (Dasatinib or Nilotinib) in patients with CML-CPExperimental Treatment3 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dasatinib
2012
Completed Phase 3
~2320
Nilotinib
2005
Completed Phase 4
~2670
Find a Location
Who is running the clinical trial?
Kartos Therapeutics, Inc.Lead Sponsor
15 Previous Clinical Trials
1,341 Total Patients Enrolled
4 Trials studying Leukemia
208 Patients Enrolled for Leukemia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has the T315I mutation.I cannot tolerate my current TKI medication.I have had a cancer treatment that didn't work or I couldn't tolerate it.I am 18 years old or older.I can care for myself and am up and about more than 50% of my waking hours.My blood, liver, and kidney functions are all within normal ranges.I have chronic myeloid leukemia in the accelerated phase and it's Ph+ and BCR-ABL+.My leukemia is TP53 wild type, Ph+, and BCR-ABL+.My leukemia is Ph+ and BCR-ABL+.I have previously been treated with MDM2 antagonist therapies.My leukemia is TP53 wild-type, Ph+, and BCR-ABL+.
Research Study Groups:
This trial has the following groups:- Group 1: Part 1, KRT-232 combined with TKI (Dasatinib or Nilotinib) in patients with CML-CP
- Group 2: Part 2, Arm A (KRT-232 combined with Dasatinib in patients with CML-CP)
- Group 3: Part 2, Arm B (KRT-232 combined with Nilotinib in patients with CML-CP)
- Group 4: Part 2, Arm C (KRT-232 combined with Dasatinib or Nilotinib in patients with CML-AP)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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