Recruiting
Phase 1
Phase 2

KRT-232 & TKI

Sponsor:

Kartos Therapeutics, Inc.

Code:

NCT04835584

Conditions

Chronic Myeloid Leukemia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

KRT-232

Dasatinib

Nilotinib

Study Details

Brief summary:

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.

Conditions

Chronic Myeloid Leukemia

Study ID

NCT04835584

Start date

May 7, 2021

Status verified date

Mar, 2022

Completion date

Jun 30, 2026

Anticipated

Primary completion date

Dec 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.
  • ECOG performance status of 0 to 2
  • Adequate hematologic, hepatic, and renal functions

Exclusion Criteria:

  • 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.
  • Intolerance to current TKI therapy.

Study Design

Enrollment

109 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part 1, KRT-232 combined with TKI (Dasatinib or Nilotinib) in patients with CML-CP

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.

experimental: Part 2, Arm A (KRT-232 combined with Dasatinib in patients with CML-CP)

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.

experimental: Part 2, Arm B (KRT-232 combined with Nilotinib in patients with CML-CP)

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.

experimental: Part 2, Arm C (KRT-232 combined with Dasatinib or Nilotinib in patients with CML-AP)

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.

Interventions

KRT-232

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

Dasatinib

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

Nilotinib

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

Primary outcome measure

  • Part 1: Maximum tolerated dose (MTD)/maximum administered dose (MAD) of KRT-232 [ Time Frame: 28 Days ]
  • Part 2, Arm A and B: Major molecular response (MMR) rate [ Time Frame: 6 months ]
  • Part 2, Arm C: Major hematological response (MaHR) rate [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

John Mei

650-542-0136jmei@kartosthera.com

Locations

University of Alabama Birmingham

Recruiting

Birmingham, Alabama, United States, 35294

Georgia Cancer Center at Augusta University

Recruiting

Augusta, Georgia, United States, 30912

University of Pittsburgh Medical Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Texas Oncology- Sammons CC at Baylor

Recruiting

Dallas, Texas, United States, 75246

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Princess Margaret Cancer Center

Recruiting

Toronto, Ontario, Canada, M5G 2C1

More Information

Sponsor

Kartos Therapeutics, Inc.

Last update posted

Mar 21, 2022

Last verified

Mar, 2022

Keywords

  • navtemadlin

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Kartos Therapeutics, Inc. on 2022-03-21.