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

Last updated: July 11, 2023
Sponsor: Telios Pharma, Inc.
Overall Status: Active - Not Recruiting

Phase

1/2

Condition

Lymphoma

Leukemia

Neoplasms

Treatment

Navtemadlin

TL-895

Clinical Study ID

NCT02825836
MS200662_0001
2016-000286-23
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria

  • 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

Exclusion Criteria

  • Prior treatment with any BTK or PI3K inhibitors

  • History of major organ transplant

  • Women who are pregnant or breastfeeding

Study Design

Total Participants: 130
Treatment Group(s): 2
Primary Treatment: Navtemadlin
Phase: 1/2
Study Start date:
August 26, 2016
Estimated Completion Date:
December 01, 2025

Connect with a study center

  • Merck KGaA Communication Center

    Darmstadt,
    Germany

    Site Not Available

  • Debreceni Egyetem - Borgyógyászati Klinika

    Debrecen, 4002
    Hungary

    Site Not Available

  • Eger Markhot Ferenc Kórház

    Eger, 3300
    Hungary

    Site Not Available

  • Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi - Istituto di Ematologia e Oncologia Medica

    Bologna, 40138
    Italy

    Site Not Available

  • Examen sp. z o. o.

    Skorzewo, Poznań 60-185
    Poland

    Site Not Available

  • Pratia MCM Krakow

    Krakow, 30-510
    Poland

    Site Not Available

  • Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli Oddzial Hematologiczny

    Lublin, 20-090
    Poland

    Site Not Available

  • Szpital Wojewódzki

    Opole, 46-020
    Poland

    Site Not Available

  • Nasz Lekarz Przychodnie Medyczne

    Toruń, 87-100
    Poland

    Site Not Available

  • Saint Petersburg State Medical University

    Saint Petersburg, 197022
    Russian Federation

    Site Not Available

  • Yaroslavl Regional Clinical Hospital

    Yaroslavl, 150023
    Russian Federation

    Site Not Available

  • Communal Non-profit Enterprise Regional Center of Oncology

    Kharkiv, 61000
    Ukraine

    Site Not Available

  • Kyiv City Clinical Hospital #4

    Kyiv, 03110
    Ukraine

    Site Not Available

  • Mykolaiv Regional Clinical Hospital

    Mykolaiv, 54058
    Ukraine

    Site Not Available

  • Barts Hospital - Cancer Centre

    London,
    United Kingdom

    Completed

  • University College London Hospitals - NIHR/Wellcome Trust

    London,
    United Kingdom

    Site Not Available

  • Derriford Hospital - Dept of Haematology

    Plymouth,
    United Kingdom

    Site Not Available

  • U.S. Medical Information

    Rockland, Massachusetts
    United States

    Site Not Available

  • Ohio State University Wexner Medical Center

    Columbus, Ohio 43210
    United States

    Site Not Available

  • The West Clinic

    Germantown, Tennessee 38138
    United States

    Site Not Available

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