A Study to Investigate the Safety of Novel Dose Ramp-up Schedule(s) When Initiating Sonrotoclax in Participants Treated for Blood Cancers.

Last updated: April 30, 2025
Sponsor: BeiGene
Overall Status: Active - Recruiting

Phase

1/2

Condition

Chronic Lymphocytic Leukemia

Lymphoproliferative Disorders

Lymphocytic Leukemia, Chronic

Treatment

Zanubrutinib

Sonrotoclax

Clinical Study ID

NCT06697184
BGB-11417-108
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to establish the safety of novel dosing and ramp-up schedules for sonrotoclax in participants with hematological malignancies.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Stable ECOG Performance Status ≤ 2.

  2. Adequate organ function and no very recent transfusion or blood growth factor

  3. Participants of childbearing potential must be willing to use a highly effectivemethod of birth control and refrain from egg donation for the duration of the studyand for ≥ 90 days after the last dose of sonrotoclax or ≥ 30 days after the lastdose of zanubrutinib, whichever is later.

  4. Confirmed diagnosis of CLL, based on Hallek et al 2018, and requiring treatment dueto certain features of their disease

  5. At least 1 measurable lesion based on computed tomography (CT)/magnetic resonanceimaging (MRI) and no history of prolymphocytic leukemia or Richter's transformation.

Exclusion

Exclusion Criteria:

  1. Participants unable to comply with the requirements of the protocol

  2. Serologic status reflecting active viral HBV or HCV infection

  3. Positive HIV serology (HIVAb) status unless certain conditions are met.

  4. Participants with any major surgical procedure ≤ 28 days before first dose of studytreatment

  5. Prior systemic treatment for the CLL

  6. Uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia requiringtreatment

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Total Participants: 56
Treatment Group(s): 2
Primary Treatment: Zanubrutinib
Phase: 1/2
Study Start date:
January 23, 2025
Estimated Completion Date:
December 31, 2027

Study Description

This study will test the safety of novel sonrotoclax dosing with gradual increases of sonrotoclax dose over specified periods until the intended target daily dose is reached. The focus will be on tumor lysis syndrome (TLS) and related toxicity signals.

In the first part of the study, each ramp-up dosing schedule will first be tested in a small group of approximately 5 to 6 participants to assess safety and establish if the schedule is suitable for further testing in additional participants (schedule calibration). In the second part of the study, approved ramp-up schedules will be further assessed for safety in approximately 50 participants (schedule expansion).

Sonrotoclax is an experimental drug that works by blocking a protein called B-cell lymphoma-2 (BCL-2). This protein helps certain types of blood tumor cells to survive and grow. When sonrotoclax blocks Bcl-2 it slows down or stops the growth of tumor cells and helps them die. This can lead to improvements in patients with certain malignant diseases including Chronic Lymphocytic leukemia (CLL). The start of treatment by BCL2 inhibitor requires progressive ramp-up over the first weeks to avoid potential consequences of initial tumor cell breakage and the release of cell content in the bloodstream. Several ramp-up schedules have already been utilized so far, and this study aims to optimize the dosing schedule by evaluating novel ones as safe, while simpler and/or faster.

Zanubrutinib is a commercialized product that works by blocking a protein called Bruton's tyrosine kinase (BTK) and controlling the activity and survival of malignant B cells. Zanubrutinib has received approval in over 65 countries/regions worldwide for the treatment of adult participants with B cell malignancies, including CLL.

This study will take place at multiple centers worldwide. The overall time to participate in this study is approximately 17 months.

Connect with a study center

  • Blacktown Cancer and Haematology Centre

    Blacktown, New South Wales 2148
    Australia

    Active - Recruiting

  • Cabrini Hospital Malvern

    Malvern, Victoria 3144
    Australia

    Site Not Available

  • Cabrini Hospital Malvern

    Malvern East, Victoria 3144
    Australia

    Site Not Available

  • The Alfred Hospital

    Melbourne, Victoria 3004
    Australia

    Active - Recruiting

  • Rockingham Hospital

    Cooloongup, Western Australia 6168
    Australia

    Active - Recruiting

  • Linear Clinical Research

    Nedlands, Western Australia 6009
    Australia

    Active - Recruiting

  • Hopital Avicenne, Aphp, Bobigny

    Bobigny, 93000
    France

    Site Not Available

  • Chu Dijon

    Dijon, 21000
    France

    Site Not Available

  • Chu Montpellier Hopital Saint Eloi

    Montpellier, 34090
    France

    Site Not Available

  • Chu Montpellier Hopital Saint Eloi

    Montpellier Cedex, 34295
    France

    Site Not Available

  • Hopital Larchet Chu Nice

    Nice, 06200
    France

    Site Not Available

  • Iuct Oncopole

    Toulouse, 31100
    France

    Site Not Available

  • Iuct Oncopole

    Toulouse Cedex, 31059
    France

    Site Not Available

  • Queen Elizabeth Hospital

    Birmingham, B15 2TH
    United Kingdom

    Site Not Available

  • University Hospitals Bristol and Weston Nhs Foundation Trust

    Bristol, BS1 3NU
    United Kingdom

    Site Not Available

  • St Jamess University Hospital

    Leeds, LS9 7TF
    United Kingdom

    Site Not Available

  • The Christie Nhs Foundation Trust Manchester

    Manchester, M20 4BX
    United Kingdom

    Site Not Available

  • Moffitt Cancer Center

    Tampa, Florida 33612-9496
    United States

    Site Not Available

  • Fort Wayne Medical Oncology and Hematology

    Fort Wayne, Indiana 46804
    United States

    Site Not Available

  • The University of Kansas Cancer Center

    Westwood, Kansas 66205-2003
    United States

    Site Not Available

  • Dana Farber Cancer Institute

    Boston, Massachusetts 02215-5418
    United States

    Site Not Available

  • Washington University

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Washington University School of Medicine

    Saint Louis, Missouri 63110-1010
    United States

    Site Not Available

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington 98109-4433
    United States

    Site Not Available

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