An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of KRT-232 Combined With a Tyrosine Kinase Inhibitor (TKI) in Patients With Relapsed or Refractory Ph+ Chronic Myeloid Leukemia (CML)
Who is this study for? Patients with relapsed or refractory Ph+ chronic myeloid leukemia
What treatments are being studied? KRT-232
Status: Recruiting
Location: See all (26) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Alabama
University of Alabama Birmingham
RECRUITING
Birmingham
Georgia
Georgia Cancer Center at Augusta University
RECRUITING
Augusta
Pennsylvania
University of Pittsburgh Medical Center
RECRUITING
Pittsburgh
Texas
Texas Oncology- Sammons CC at Baylor
RECRUITING
Dallas
Wisconsin
Medical College of Wisconsin
RECRUITING
Milwaukee
Other Locations
Canada
Princess Margaret Cancer Center
RECRUITING
Toronto
France
Centre Leon Berard
RECRUITING
Lyon
APHM Hopital de la Timone
RECRUITING
Marseille
Institut Paoli-Calmettes
RECRUITING
Marseille
Centre Hospitalier Lyon Sud
RECRUITING
Saint-genis-laval
Italy
Azienda Ospedaliero - Universitaria Mater Domini
RECRUITING
Catanzaro
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori
RECRUITING
Meldola Fc
Policlinico di Milano Ospedale Maggiore | Fondazione IRCCS Ca' Granda
RECRUITING
Milan
Fondazione IRCCS Policlinico San Matteo
RECRUITING
Pavia
Poland
Pratia Onkologia Katowice
RECRUITING
Katowice
Republic of Korea
Kyungpook National University Hospital
RECRUITING
Daegu
Samsung Medical Center
RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
Severance Hospital
RECRUITING
Seoul
Russian Federation
National Medical Research Center of Hematology
RECRUITING
Moscow
Almazov National Medical Research Center
RECRUITING
Saint Petersburg
Samara State Medical University
RECRUITING
Samara
Spain
Hospital Universitari Vall d'Hebron
RECRUITING
Barcelona
Clínica Universidad de Navarra
RECRUITING
Madrid
Hospital Universitario La Paz
RECRUITING
Madrid
Clinica Universidad de Navarra
RECRUITING
Pamplona
Contact Information
Primary
John Mei
jmei@kartosthera.com
650-542-0136
Time Frame
Start Date: 2021-05-07
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 109
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Kartos Therapeutics, Inc.