← Back to Search

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 below
Select...
I have had a cancer treatment that didn't work or I couldn't tolerate it.
Select...
I am 18 years old or older.
Select...
I can care for myself and am up and about more than 50% of my waking hours.
Select...
My blood, liver, and kidney functions are all within normal ranges.
Select...
My leukemia is TP53 wild type, Ph+, and BCR-ABL+.
Select...
My leukemia is TP53 wild-type, Ph+, and BCR-ABL+.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~47 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 47 months for reporting.

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 more

Trial 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

KRT-232 (MDM2 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04835584 — Phase 1 & 2
Leukemia Research Study Groups: Part 1, KRT-232 combined with TKI (Dasatinib or Nilotinib) in patients with CML-CP, Part 2, Arm A (KRT-232 combined with Dasatinib in patients with CML-CP), Part 2, Arm B (KRT-232 combined with Nilotinib in patients with CML-CP), Part 2, Arm C (KRT-232 combined with Dasatinib or Nilotinib in patients with CML-AP)
Leukemia Clinical Trial 2023: KRT-232 Highlights & Side Effects. Trial Name: NCT04835584 — Phase 1 & 2
KRT-232 (MDM2 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04835584 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the primary indication of KRT-232?

"KRT-232 is a medication used to treat various cancers like myeloid leukemia, gastrointestinal stromal tumors, and leukemia."

Answered by AI

Are there any other instances where KRT-232 has been explored?

"KRT-232 was first researched in 2004 at Bronson Battle Creek. As of now, there have been a total of 216 completed studies. Out of these, 102 are ongoing, with a majority of them taking place in Toronto, Ontario."

Answered by AI

What goals is this experiment looking to achieve?

"The primary focus of this 28 day clinical trial is to investigate the rate of Major hematological response (MaHR) in Part 2, Arm C. Additionally, the study will collect data on Progression-free survival (PFS), Overall survival (OS), and MCyR rate in order to understand the secondary outcomes of the trial."

Answered by AI

How many research centers are conducting this trial?

"There are a total of 9 clinical trial sites for this research project. The primary locations are Princess Margaret Cancer Center in Toronto, Georgia Cancer Center at Augusta University, and Texas Oncology- Sammons CC at Baylor. The other 6 sites are located across the United States."

Answered by AI

How many individuals are chosen to participate in this research?

"That is correct. The clinical trial in question, as indicated by clinicaltrials.gov, is still recruiting patients. This specific trial was initially posted on May 7th, 2021 and was last updated on March 4th, 2022. The trial needs a total of 109 patients, which will be drawn from 6 different sites."

Answered by AI

Are there currently any open spots in this clinical trial?

"Yes, the information on clinicaltrials.gov point out that this clinical trial is currently searching for participants. The clinical trial was originally posted on 5/7/2021 and was most recently edited on 3/4/2022. The trial is admitting 109 participants between 6 sites."

Answered by AI
~23 spots leftby Dec 2024