Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
18 participants
INTERVENTIONAL
2021-03-31
2025-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Phase 1b - Dose Level 1
KRT-232 240mg QD, orally administered on days 1 through 7 of each 28-day cycle in combination with TL-895 150mg BID continuously for each 28-day cycle.
TL-895
TL-895 is an experimental tyrosine kinase inhibitor anticancer drug taken by mouth.
KRT-232
KRT-232 is an experimental MDM2 inhibitor anticancer drug taken by mouth.
Phase 1b - Dose Level 2
KRT-232 300mg QD, orally administered on days 1 through 7 of each 28-day cycle in combination with TL-895 150mg BID continuously for each 28-day cycle.
TL-895
TL-895 is an experimental tyrosine kinase inhibitor anticancer drug taken by mouth.
KRT-232
KRT-232 is an experimental MDM2 inhibitor anticancer drug taken by mouth.
Phase 1b - Dose Level 3
Cycle 1 only: KRT-232 360 mg QD orally administered on Days 1 through 7 of the first 28-day cycle in combination with TL-895 150 mg BID continuously for the first 28-day cycle
Cycle 2 and beyond: KRT-232 300 mg QD orally administered on Days 1 through 7 of each 28-day cycle in combination with TL-895 150 mg BID continuously for each 28-day cycle.
TL-895
TL-895 is an experimental tyrosine kinase inhibitor anticancer drug taken by mouth.
KRT-232
KRT-232 is an experimental MDM2 inhibitor anticancer drug taken by mouth.
Phase 1b - Dose Level 4
Cycle 1 only: KRT-232 360 mg QD orally administered on Days 1 through 7 of the first 28-day cycle in combination with TL-895 300 mg BID continuously for the first 28-day cycle.
Cycle 2 and beyond: KRT-232 300 mg QD orally administered on Days 1 through 7 of each 28-day cycle in combination with TL-895 300 mg BID continuously for each 28-day cycle.
TL-895
TL-895 is an experimental tyrosine kinase inhibitor anticancer drug taken by mouth.
KRT-232
KRT-232 is an experimental MDM2 inhibitor anticancer drug taken by mouth.
Phase 1b - Dose Level 5
Cycle 1 only: KRT-232 360 mg QD orally administered on Days 1 through 7 of the first 28-day cycle in combination with TL-895 450 mg BID continuously for the first 28-day cycle.
Cycle 2 and beyond: KRT-232 300 mg QD orally administered on Days 1 through 7 of each 28-day cycle in combination with TL-895 450 mg BID continuously for each 28-day cycle.
TL-895
TL-895 is an experimental tyrosine kinase inhibitor anticancer drug taken by mouth.
KRT-232
KRT-232 is an experimental MDM2 inhibitor anticancer drug taken by mouth.
Phase 2 - Dose Expansion
Dose expansion of the recommended phase 2 dose of TL-895 in combination with KRT-232 as determined in Phase 1b.
TL-895
TL-895 is an experimental tyrosine kinase inhibitor anticancer drug taken by mouth.
KRT-232
KRT-232 is an experimental MDM2 inhibitor anticancer drug taken by mouth.
Interventions
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TL-895
TL-895 is an experimental tyrosine kinase inhibitor anticancer drug taken by mouth.
KRT-232
KRT-232 is an experimental MDM2 inhibitor anticancer drug taken by mouth.
Eligibility Criteria
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Inclusion Criteria
* Relapsed/Refractory to at least one prior therapy, one of which must have included a FLT-3 inhibitor
* FLT3 mutation (FLT3-TKD or FLT3-ITD)
* ECOG 0-2
* Adequate hematologic, hepatic, and renal functions
Exclusion Criteria
* Prior treatment with MDM2 antagonist therapies
* Eligible for HSCT
18 Years
ALL
No
Sponsors
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Kartos Therapeutics, Inc.
INDUSTRY
Telios Pharma, Inc.
INDUSTRY
Responsible Party
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Locations
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Keck School of Medicine
Los Angeles, California, United States
University of California, Irvine Medical Center
Orange, California, United States
Georgia Cancer Center
Augusta, Georgia, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
Rush University Medical Center, Division of Hematology Oncology and Cell Therapy
Chicago, Illinois, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Weill Cornell Medical College
New York, New York, United States
University of Cincinnati
Cincinnati, Ohio, United States
Thomas Jefferson University, Sidney Kimmel Cancer Center, Clinical Research Organization
Philadelphia, Pennsylvania, United States
UT Southwestern Medical Center, Harold C. Simmons Cancer Center
Dallas, Texas, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States
University of Sunshine Coast-Sippy Downs
Sippy Downs, , Australia
Westmead Hospital
Sydney, , Australia
Ordensklinikum Linz GmbH Elisabethinen
Linz, , Austria
Medical University Vienna, Department of Internal Medicine I, Clinical Department of Hematology and Hemostaseology
Vienna, , Austria
Claude Huriez Hospital
Lille, , France
South Lyon Hospital Center
Lyon, , France
Paoli-Calmettes Institute
Marseille, , France
University Hospital of Nantes
Nantes, , France
Hospital Center Universitaire De Nice
Nice, , France
Saint-Louis Hospital
Paris, , France
University Hospital Halle (Saale), Department of Internal Medicine IV - Hematology and Oncology
Halle, Saxony-Anhalt, Germany
University Duisburg-Essen, University Hospital Essen, Department of Internal Medicine
Essen, , Germany
University Hospital Hamburg-Eppendorf, Department of Internal Medicine II
Hamburg, , Germany
Hannover Medical School, Center for Internal Medicine, Clinic of Hematology, Hemostaseology, Oncology and Stem Cell Transplantation
Hanover, , Germany
University Hospital Jena, Clinic of Internal Medicine II, Department of Hematology and Medical Oncology
Jena, , Germany
University Hospital - Ospedali Riuniti Umberto I - GM Lancisi - G Salesi of Ancona, Haematology Clinic
Ancona, , Italy
Polyclinic S. Orsola-Malpighi, Operative Unit of Hematology
Bologna, , Italy
Romagnolo Scientific Institute of Meldola (IRST) S.r.l., Department of Oncology and Clinical and Experimental Haematology
Meldola, , Italy
Gachon University Gil Medical Center
Incheon, , South Korea
Seoul National University Hospital, Department of Hemato-Oncology
Seoul, , South Korea
University Hospital Germans Trias i Pujol, Department of Clinical Hematology
Badalona, , Spain
University Hospital Vall d'Hebron
Barcelona, , Spain
University Clinical Hospital of Valencia, Department of Hematology and Medical Oncology
Valencia, , Spain
Hospital Universitario y Politécnico de La Fe
Valencia, , Spain
Countries
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Other Identifiers
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TL-895-203
Identifier Type: -
Identifier Source: org_study_id
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