Health TrialsbyHealthPanel

KRT-232 and TKI Study in Chronic Myeloid Leukemia

ConditionChronic Myeloid Leukemia
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorKartos Therapeutics, Inc.

About this trial

This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, for the treatment of patients with Ph+ Chronic Myeloid Leukemia (CML) who have relapsed or are refractory or intolerant to a Tyrosine Kinase Inhibitor (TKI).

This study is a global, open label Phase 1b/2 to determine the efficacy and safety of KRT-232 in patients with chronic phase CML (CML-CP) and accelerated phase (CML-AP) who have failed TKI treatments.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • KRT-232

    Drug

    KRT-232 is an experimental MDM2 inhibitor anticancer drug taken by mouth.

  • Dasatinib

    Drug

    Dasatinib is a Tyrosine Kinase Inhibitor anticancer drug taken by mouth.

  • Nilotinib

    Drug

    Nilotinib is an Tyrosine Kinase Inhibitor anticancer drug taken by mouth.

Treatment groups

109 Participants
are divided into 4 treatment groups
Group A: Part 1, KRT-232 combined with TKI (Dasatinib or Nilotinib) in patients with CML-CPExperimental treatment 3 interventions
Group B: Part 2, Arm A (KRT-232 combined with Dasatinib in patients with CML-CP)Experimental treatment 2 interventions
Group C: Part 2, Arm B (KRT-232 combined with Nilotinib in patients with CML-CP)Experimental treatment 2 interventions
Group D: Part 2, Arm C (KRT-232 combined with Dasatinib or Nilotinib in patients with CML-AP)Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Part 1: Maximum tolerated dose (MTD)/maximum administered dose (MAD) of KRT-232

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

Time frame
28 Days
2

Part 2, Arm A and B: Major molecular response (MMR) rate

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

Time frame
6 months
3

Part 2, Arm C: Major hematological response (MaHR) rate

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

Time frame
6 months

Secondary outcomes

1

CCyR rate

The proportion of subjects who achieved CCyR or PCyR according to modified ELN criteria in Arms A and B

Time frame
12 months
2

MCyR rate

The proportion of subjects who achieved CCyR or PCyR according to modified ELN criteria in Arm C

Time frame
47 months
3

Duration of response

DOR (Kaplan-Meier estimate) defined as the time from first observation of response to progression/relapse or death, whichever comes first

Time frame
47 months
4

Rate of complete hematologic response (CHR)

The proportion of subjects who achieve a CHR according to modified ELN criteria in Arms A and B

Time frame
47 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kartos Therapeutics, Inc.

Lead sponsor

Source ClinicalTrials.gov
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