KRT-232 in Combination With TL-895 for the Treatment of R/R MF and KRT-232 for the Treatment of JAKi Intolerant MF
NCT ID: NCT04640532
Last Updated: 2022-05-09
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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UNKNOWN
PHASE1/PHASE2
116 participants
INTERVENTIONAL
2020-11-17
2025-07-24
Brief Summary
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Detailed Description
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Cohort 1 will follow a 3+3 dose escalation design to determine the maximum tolerated dose (MTD)/maximum administered dose (MAD) and recommended Phase 2 dose (RP2D) of TL-895 administered QD in combination with KRT-232. A Safety Review Committee (SRC) will review the safety data during the dose escalation to decide on dose escalation and/or exploration of intermediate doses.
Cohort 2 will follow a 3+3 dose escalation design to determine the MTD/MAD and recommended RP2D of TL-895 administered BID in combination with KRT-232. An SRC will review the safety data during the dose escalation to decide on dose escalation and/or exploration of intermediate doses.
Cohort 3 will be conducted a 2-stage design. In stage 1, enrollment will continue until 15 evaluable patients have been enrolled. An SRC will review the data during the study and if there are ≥4 responders based on the futility criteria and safety data from Stage 1, Cohort 3 expansion will commence. If there are ≤3 patients responding to therapy, Cohort 3 will be terminated. Once expansion criteria have been met, Cohort 3 will be expanded to a total of 46 evaluable patients for Stage 2 analyses.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Cohort 1 (R/R MF), Dose Level 1
TL-895 at 200 mg once a day (QD) continuously starting on Cycle 1 Day 1 in a 28-day cycle.
KRT-232 240mg will be administered orally, once daily (QD), on days 1-7 in a 28-day cycle starting on Cycle 2 Day 1.
KRT-232
KRT-232, administered by mouth
TL-895
TL-895, administered by mouth
Cohort 1 (R/R MF), Dose Level 2
TL-895 at 300 mg once a day (QD) continuously starting on Cycle 1 Day 1 in a 28-day cycle.
KRT-232 at 240mg will be administered orally, once daily (QD), on days 1-7 in a 28-day cycle starting on Cycle 2 Day 1.
KRT-232
KRT-232, administered by mouth
TL-895
TL-895, administered by mouth
Cohort 2 (R/R MF), Dose Level 1
TL-895 at 100 mg twice a day (BID) continuously starting on Cycle 1 Day 1 in a 28-day cycle.
KRT-232 at 240mg will be administered orally, once daily (QD), on days 1-7 in a 28-day cycle starting on Cycle 2 Day 1.
KRT-232
KRT-232, administered by mouth
TL-895
TL-895, administered by mouth
Cohort 2 (R/R MF), Dose Level 2
TL-895 at 150 mg twice a day (BID) continuously starting on Cycle 1 Day 1 in a 28-day cycle.
KRT-232 at 240mg will be administered orally, once daily (QD), on days 1-7 in a 28-day cycle starting on Cycle 2 Day 1.
KRT-232
KRT-232, administered by mouth
TL-895
TL-895, administered by mouth
Cohort 3 (JAKi Intolerant MF)
KRT-232 at 240mg will be administered orally, once daily (QD), on days 1-7 in a 28-day cycle.
KRT-232
KRT-232, administered by mouth
Interventions
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KRT-232
KRT-232, administered by mouth
TL-895
TL-895, administered by mouth
Eligibility Criteria
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Inclusion Criteria
* ECOG ≤ 2
* Cohort 1 and Cohort 2: R/R following JAK inhibitor treatment
* Cohort 3: patients who are intolerant to JAK inhibitor treatment
Exclusion Criteria
* Prior treatment with a BCR-ABL, phosphoinositide 3-kinase (PI3k), mammalian target of rapamycin (mTOR), bromodomain and extraterminal domain (BET), histone deacetylase (HDAC), or spleen tyrosine kinase (Syk) inhibitor
* Prior splenectomy
* Splenic irradiation within 3 months prior to the first dose of study treatment
* Clinically significant thrombosis within 3 months of screening
* Grade 2 or higher QTc prolongation
18 Years
ALL
No
Sponsors
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Telios Pharma, Inc.
INDUSTRY
Kartos Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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University of Alabama at Birmingham School of Medicine, Division of Hematology and Oncology
Birmingham, Alabama, United States
The Oncology Institute of Hope
Whittier, California, United States
Lake City Cancer Center
Lake City, Florida, United States
Carle Cancer Center
Urbana, Illinois, United States
Columbia University Medical Center
Fort Lee, New Jersey, United States
Memorial Sloan Kettering Cancer Center (MSKCC)
New York, New York, United States
LKH Hochsteiermark
Leoben, , Austria
Meduni Wien, Univ. Klinik für Innere Medizin I
Vienna, , Austria
University Multiprofile Hospital for Active Treatment Dr. Georgi Stranski, Pleven
Pleven, , Bulgaria
University Multiprofile Hospital for Active Treatment Dr. Georgi Plovdiv
Plovdiv, , Bulgaria
Hematology Clinic Specialized Hospital for Active Treatment of Hematological Diseases, Sofia
Sofia, , Bulgaria
Chu Amiens Picardie Site Sud
Amiens, , France
CHU de Limoges Service Hématologie Clinique et Thérapie Cellulaire
Limoges, , France
CHU Nantes - Hôtel Dieu
Nantes, , France
CHU de Nice Hospital
Nice, , France
Hôpital Saint Louis
Paris, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
University Hospital Halle (Saale), Department of Internal Medicine IV - Hematology and Oncology
Halle, , Germany
University Hospital Marburg, Department of Hematology, Oncology and Immunology
Marburg, , Germany
Moritz Kaposi General Hospital, Department of Hematology
Kaposvár, , Hungary
Szabolcs-Szatmar-Bereg County Hospitals and University Teaching Hospital, Department of Hematology
Nyíregyháza, , Hungary
Medical Center of the University of Pecs, 1st Department of Internal Medicine, Division of Hematology
Pécs, , Hungary
Fejer County St. Gyorgy University Teaching Hospital, Department of Internal Medicine III, Hematology
Székesfehérvár, , Hungary
Polyclinic S. Orsola-Malpighi
Bologna, , Italy
ASST Spedali Civili di Brescia
Brescia, , Italy
Careggi University Hospital
Florence, , Italy
Hospital Casa Sollievo della Sofferenza, Department of Oncology and Hematology, Division of Hematology
Foggia, , Italy
Hospital of Ravenna, Operative Unit of Hematology
Ravenna, , Italy
Jan Biziel University Hospital #2 in Bydgoszcz, Department of Hematology
Bydgoszcz, , Poland
Pratia Onkologia Katowice
Katowice, , Poland
Frederic Chopin Provincial Teaching Hospital No. 1 in Rzeszow, Department of Hematology
Rzeszów, , Poland
Slupsk Provincial Specialist Hospital n.a. Janusz Korczak, Department of Hematology
Słupsk, , Poland
Nasz Lekarz Medical Outpatient Clinics Slawomir Jeka
Torun, , Poland
Clinical Center of Serbia
Belgrade, , Serbia
Clinical Center of Vojvodina
Novi Sad, , Serbia
Hematologia Clínica
Barcelona, , Spain
University Clinical Hospital of Salamanca, Department of Hematology
Salamanca, , Spain
Countries
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Central Contacts
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Other Identifiers
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KRT-232-113
Identifier Type: -
Identifier Source: org_study_id
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