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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.

Must not have

Known T315I mutation.

Intolerance to current TKI therapy.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 47 months

Awards & highlights

No Placebo-Only Group

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.

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.

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

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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+.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer has the T315I mutation.

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I cannot tolerate my current TKI medication.

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I have chronic myeloid leukemia in the accelerated phase and it's Ph+ and BCR-ABL+.

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My leukemia is Ph+ and BCR-ABL+.

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I have previously been treated with MDM2 antagonist therapies.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 47 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

CCyR rate

Duration of response

MCyR rate

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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