Phase I/II, FIH, Dose Escalation Trial of TL-895 and Expansion of TL-895 Monotherapy and Combination Therapy With Navtemadlin in Tx-Naïve and R/R CLL/SLL Subjects
NCT ID: NCT02825836
Last Updated: 2023-07-13
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
130 participants
INTERVENTIONAL
2016-08-26
2025-12-01
Brief Summary
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Arms 1 \& 2 of Part 2 of this study will test different doses of TL-895 in participants with R/R CLL or SLL who have failed at least 1 prior therapy. Arms 1 \& 2 of Part 2 of this study is randomized (like the flip of a coin) to receive a specific treatment dose. If someone participates in arms 1 or 2 of Part 2, the dose they receive will be either 100mg twice a day or 150mg twice a day.
Arms 3 and 4 of Part 2 of this study will test the 150mg and 100mg BID dose of TL-895, respectively in treatment naïve participants with CLL/SLL.
Arms 5 and 6 of Part 2 will test 150mg TL-895 BID in combination with 240 mg navtemadlin QD in participants with relapsed/refractory and treatment naïve without 17p(del). Arm 7 will test 150mg TL-895 in combination with 240 mg navtemadlin QD in participants with relapsed/refractory CLL/SLL with 17p(del).
Every participant in this study will receive TL-895.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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TL-895 80/160 mg QD in R/R Participants
Participants received TL-895 80 mg powder in capsule (PiC) orally once daily (OD) for 3 days followed by TL-895 160 mg OD in fasted state for 28 days in each 28 day cycle until disease progression, withdrawal of consent, or discontinuation from the study.
TL-895
TL-895 is an experimental tyrosine kinase inhibitor anticancer drug taken by mouth.
TL-895 300 mg QD in R/R Participants
Participants received TL-895 300 mg PiC orally OD in fasted state for 28 days in each 28 day cycle until disease progression, withdrawal of consent, or discontinuation from the study.
TL-895
TL-895 is an experimental tyrosine kinase inhibitor anticancer drug taken by mouth.
TL-895 600 mg QD in R/R Participants
Participants received TL-895 600 mg PiC orally OD in fasted state for 28 days in each 28 day cycle until disease progression, withdrawal of consent, or discontinuation from the study.
TL-895
TL-895 is an experimental tyrosine kinase inhibitor anticancer drug taken by mouth.
TL-895 300 mg BID in R/R Participants
Participants received TL-895 300 mg PiC orally twice daily (BID) in fasted state for 28 days in each 28 day cycle until disease progression, withdrawal of consent, or discontinuation from the study.
TL-895
TL-895 is an experimental tyrosine kinase inhibitor anticancer drug taken by mouth.
TL-895 900 mg QD in R/R Participants
Participants received TL-895 900 mg PiC orally QD in fasted state for 28 days in each 28 day cycle until disease progression, withdrawal of consent, or discontinuation from the study.
TL-895
TL-895 is an experimental tyrosine kinase inhibitor anticancer drug taken by mouth.
TL-895 100 mg BID in R/R Participants
Participants received TL-895 100 mg BID orally with food for 28 days in each 28 day cycle until disease progression, withdrawal of consent, or discontinuation from the study.
TL-895
TL-895 is an experimental tyrosine kinase inhibitor anticancer drug taken by mouth.
TL-895 150 mg BID in R/R Participants
Participants received TL-895 150 mg BID orally with food for 28 days in each 28 day cycle until disease progression, withdrawal of consent, or discontinuation from the study.
TL-895
TL-895 is an experimental tyrosine kinase inhibitor anticancer drug taken by mouth.
TL-895 150 mg BID in Treatment Naïve Participants
Participants received TL-895 150 mg BID orally with food for 28 days in each 28 day cycle until disease progression, withdrawal of consent, or discontinuation from the study.
TL-895
TL-895 is an experimental tyrosine kinase inhibitor anticancer drug taken by mouth.
TL-895 100 mg BID in Treatment Naïve Participants
Participants received TL-895 100 mg BID orally with food for 28 days in each 28 day cycle until disease progression, withdrawal of consent, or discontinuation from the study.
TL-895
TL-895 is an experimental tyrosine kinase inhibitor anticancer drug taken by mouth.
TL-895 150 mg BID & navtemadlin 240mg QD in R/R Participants without 17p(del)
Participants received navtemadlin 240 mg administered QD on Days 1-7 in combination with TL-895 150 mg BID orally with food for 28 days with in each 28 day cycle until disease progression, withdrawal of consent, or discontinuation from the study.
TL-895
TL-895 is an experimental tyrosine kinase inhibitor anticancer drug taken by mouth.
Navtemadlin
Navtemadlin is an experimental MDM2 anticancer drug taken by mouth.
TL-895 150 mg BID & navtemadlin 240mg QD in Treatment Naïve Participants without 17p(del)
Participants received navtemadlin 240 mg administered QD on Days 1-7 in combination with TL-895 150 mg BID orally with food for 28 days with in each 28 day cycle until disease progression, withdrawal of consent, or discontinuation from the study.
TL-895
TL-895 is an experimental tyrosine kinase inhibitor anticancer drug taken by mouth.
Navtemadlin
Navtemadlin is an experimental MDM2 anticancer drug taken by mouth.
TL-895 150 mg BID & navtemadlin 240mg QD in R/R Participants with 17p(del)
Participants received navtemadlin 240 mg administered QD on Days 1-7 in combination with TL-895 150 mg BID orally with food for 28 days with in each 28 day cycle until disease progression, withdrawal of consent, or discontinuation from the study.
TL-895
TL-895 is an experimental tyrosine kinase inhibitor anticancer drug taken by mouth.
Navtemadlin
Navtemadlin is an experimental MDM2 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.
Navtemadlin
Navtemadlin is an experimental MDM2 anticancer drug taken by mouth.
Eligibility Criteria
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Inclusion Criteria
* Treatment naïve CLL or SLL (Arm 3, 4, and 6)
* ECOG performance status of ≤ 2
* Adequate hematologic, hepatic, and renal functions
Exclusion Criteria
* History of major organ transplant
* Women who are pregnant or breastfeeding
18 Years
ALL
No
Sponsors
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Telios Pharma, Inc.
INDUSTRY
Responsible Party
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Locations
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Ohio State University Wexner Medical Center
Columbus, Ohio, United States
The West Clinic
Germantown, Tennessee, United States
Debreceni Egyetem - Borgyógyászati Klinika
Debrecen, , Hungary
Eger Markhot Ferenc Kórház
Eger, , Hungary
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi - Istituto di Ematologia e Oncologia Medica
Bologna, , Italy
Examen sp. z o. o.
Skorzewo, Poznań, Poland
Pratia MCM Krakow
Krakow, , Poland
Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli Oddzial Hematologiczny
Lublin, , Poland
Szpital Wojewódzki
Opole, , Poland
Nasz Lekarz Przychodnie Medyczne
Torun, , Poland
Saint Petersburg State Medical University
Saint Petersburg, , Russia
Yaroslavl Regional Clinical Hospital
Yaroslavl, , Russia
Communal Non-profit Enterprise Regional Center of Oncology
Kharkiv, , Ukraine
Kyiv City Clinical Hospital #4
Kyiv, , Ukraine
Mykolaiv Regional Clinical Hospital
Mykolaiv, , Ukraine
University College London Hospitals - NIHR/Wellcome Trust
London, , United Kingdom
Derriford Hospital - Dept of Haematology
Plymouth, , United Kingdom
Countries
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References
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Eugenio Gaudio, Chiara Tarantelli, Emanuele Zucca, Davide Rossi, Anastasios Stathis, Francesco Bertoni. The two novel BTK-inhibitors M2951 and M7583 show in vivo anti-tumor activity in pre-clinical models of B cell lymphoma [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2017; 2017 Apr 1-5; Washington, DC. Philadelphia (PA): AACR; Cancer Res 2017;77(13 Suppl):Abstract nr 4182. doi:10.1158/1538-7445.AM2017-4182
Goodstal SM, Lin J, Crandall T, Crowley L, Bender AT, Pereira A, Soloviev M, Wesolowski JS, Iadevaia R, Schelhorn SE, Ross E, Morandi F, Ma J, Clark A. Preclinical evidence for the effective use of TL-895, a highly selective and potent second-generation BTK inhibitor, for the treatment of B-cell malignancies. Sci Rep. 2023 Nov 21;13(1):20412. doi: 10.1038/s41598-023-47735-z.
Wojciech Jurczak, Simon Rule, William Townsend, David Tucker, Martin Dyroff, Barbara Sarholz, Jürgen Scheele, John G. Gribben and Pier Luigi Zinzani. First in Human, Phase I/II Trial of the Bruton's Tyrosine Kinase Inhibitor (BTKi) M7583 in Patients with B Cell Malignancies: Study Design and Initial Outcomes. Blood 2017 130:2778.
Jurczak W, Rule S, Townsend W, Tucker D, Sarholz B, Scheele J, Dyroff M, Gribben JG, Dlugosz-Danecka M, Zinzani PL. Phase I, first-in-human trial of Bruton's tyrosine kinase inhibitor M7583 in patients with B-cell malignancies. Leuk Lymphoma. 2021 Oct;62(10):2392-2399. doi: 10.1080/10428194.2021.1913139. Epub 2021 Apr 24.
Other Identifiers
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2016-000286-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MS200662_0001
Identifier Type: -
Identifier Source: org_study_id
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