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
Status unconfirmed · Phase 1/Phase 2
Conditions studied: Relapsed/Refractory B Cell Malignancies, Mantle Cell Lymphoma and Diffuse Large B Cell Lymphoma, Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Treatment-Naive B Cell Malignancies
In brief
The purpose of this research study is to determine the safety and tolerability of TL-895. There are 2 parts of this study. Part 1 tested increasing doses of TL-895 to identify the recommended safe dose for participants with relapsed/refractory (R/R) B cell malignancies who failed at least 1 but no more than 3 prior therapies. Part 1 of this study is no longer enrolling participants. 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.
Key facts
- Study ID
- NCT02825836
- Run by
- Telios Pharma, Inc.
- People needed
- 130
- Starts
- 2016-08-26
- Expected to finish
- 2025-12-01
- Last updated by the study team
- 2023-07-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Relapsed/refractory CLL or relapsed/refractory SLL (Arms 1, 2, 5, and 7)
- Treatment naïve CLL or SLL (Arm 3, 4, and 6)
- ECOG performance status of ≤ 2
- Adequate hematologic, hepatic, and renal functions
You may not qualify if…
- Prior treatment with any BTK or PI3K inhibitors
- History of major organ transplant
- Women who are pregnant or breastfeeding
Where it is running
- 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
Full record on ClinicalTrials.gov
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