Study of TL-895 Combined With Ruxolitinib in JAKi Treatment-Naïve MF Subjects and Subjects With MF Who Have a Suboptimal Response to Ruxolitinib
NCT ID: NCT05280509
Last Updated: 2023-02-21
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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RECRUITING
PHASE1/PHASE2
70 participants
INTERVENTIONAL
2022-06-09
2027-04-30
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
PARALLEL
TREATMENT
NONE
Study Groups
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Phase 1b - Dose Level 1
150 mg of TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle combined with the subject's pre-study stable dose of ruxolitinib.
TL-895
TL-895 is an experimental tyrosine kinase inhibitor anticancer drug taken by mouth.
Ruxolitinib
Ruxolitinib is an FDA-approved janus kinase inhibitor anticancer drug taken by mouth.
Phase 1b - Dose Level 2
300 mg of TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle combined with the subject's pre-study stable dose of ruxolitinib.
TL-895
TL-895 is an experimental tyrosine kinase inhibitor anticancer drug taken by mouth.
Ruxolitinib
Ruxolitinib is an FDA-approved janus kinase inhibitor anticancer drug taken by mouth.
Phase 1b - Dose Level 3
450 mg of TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle combined with the subject's pre-study stable dose of ruxolitinib.
TL-895
TL-895 is an experimental tyrosine kinase inhibitor anticancer drug taken by mouth.
Ruxolitinib
Ruxolitinib is an FDA-approved janus kinase inhibitor anticancer drug taken by mouth.
Phase 2 - Cohort 1 JAKi treatment-naïve MF
The RP2D of TL-895 as determined in Phase 1b will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle.
The dose of ruxolitinib will be based on the subject's baseline platelet count.
TL-895
TL-895 is an experimental tyrosine kinase inhibitor anticancer drug taken by mouth.
Ruxolitinib
Ruxolitinib is an FDA-approved janus kinase inhibitor anticancer drug taken by mouth.
Phase 2 - Cohort 2 suboptimal response to Ruxolitinib
The RP2D of TL-895 as determined in Phase 1b will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle.
The dose schedule will be the stable ruxolitinib dose schedule as the subject is currently taking prior to entry into the study.
TL-895
TL-895 is an experimental tyrosine kinase inhibitor anticancer drug taken by mouth.
Ruxolitinib
Ruxolitinib is an FDA-approved janus kinase 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.
Ruxolitinib
Ruxolitinib is an FDA-approved janus kinase inhibitor anticancer drug taken by mouth.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Treatment with at a stable dose of ruxolitinib prior to study entry
* Subjects ≥ 18 years of age and able to provide informed consent.
* Confirmed diagnosis of PMF, post-PV MF, or post-ET MF, as assessed by treating physician according to the World Health Organization (WHO) criteria
* High-risk, intermediate-2 risk, or intermediate-1 risk, defined by Dynamic International Prognostic System (DIPSS)
* Palpable spleen measuring ≥ 5 cm below the left lower coastal margin (LLCM) or spleen volume of ≥ 450 cm3 by MRI or CT scan assessment
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
* Adequate hematological, hepatic, \& renal function.
Exclusion Criteria
* Prior treatment with any JAKi
Subjects with suboptimal response to ruxolitinib:
* Documented disease progression while on ruxolitinib treatment
All subjects:
* Prior splenectomy or splenic irradiation within 24 weeks prior to first dose of study treatment
* Prior treatment with a BTK or BMX inhibitor
18 Years
ALL
No
Sponsors
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Telios Pharma, Inc.
INDUSTRY
Responsible Party
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Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Gabrail Cancer Center
Canton, Ohio, United States
University of Cincinnati (UC)
Cincinnati, Ohio, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
CHU Angers
Angers, , France
AP-HM - Hôpital de la Timone
Marseille, , France
CHU de Nice - Hopital L'Archet II
Nice, , France
Hôpital Saint Louis - AP-HP
Paris, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
Marien Hospital Duesseldorf
Düsseldorf, , Germany
Klinik fur Innere Medizin IV - Hamatologie/Onkologie, Universitatsklinikum Hall
Halle, , Germany
IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant'Orsola
Bologna, , Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano
Milan, , Italy
Azienda Ospedaliera di Perugia-Ospedale S. Maria della Misericordia
Perugia, , Italy
Pratia Onkologia Katowice
Katowice, , Poland
Hospital Universitari Arnau de Vilanova
Lleida, , Spain
Hospital Universitario Ramon y Cajal
Madrid, , Spain
Hospital Universitario Virgen de la Victoria
Málaga, , Spain
Hospital Quironsalud de Zaragoza
Zaragoza, , Spain
Countries
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Central Contacts
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Other Identifiers
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TL-895-209
Identifier Type: -
Identifier Source: org_study_id
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