KRT-232 and TKI Study in Chronic Myeloid Leukemia

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Kartos Therapeutics, Inc.
Study ID
NCT04835584
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
May 7, 2021
Status verified
Mar 2022
Primary completion
Dec 31, 2024
Completion
Jun 30, 2026

Study Design

Enrollment
109 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Part 1: Maximum tolerated dose (MTD)/maximum administered dose (MAD) of KRT-232 [ Time Frame: 28 Days ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
University of Alabama BirminghamBirminghamAlabama35294-
Georgia Cancer Center at Augusta UniversityAugustaGeorgia30912-
University of Pittsburgh Medical CenterPittsburghPennsylvania15232-
Texas Oncology- Sammons CC at BaylorDallasTexas75246-
Medical College of WisconsinMilwaukeeWisconsin53226-

Find similar trials in Birmingham, AL

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
University of Alabama Birmingham· Birmingham, ALGeorgia Cancer Center at Augusta University· Augusta, GAUniversity of Pittsburgh Medical Center· Pittsburgh, PATexas Oncology- Sammons CC at Baylor· Dallas, TXMedical College of Wisconsin· Milwaukee, WI

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