A Study to Investigate the Safety of Novel Dose Ramp-up Schedule(s) When Initiating Sonrotoclax in Participants Treated for Blood Cancers.
NCT ID: NCT06697184
Last Updated: 2025-12-17
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
56 participants
INTERVENTIONAL
2025-01-23
2027-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part 1: Schedule Calibration
Participants will receive zanubrutinib monotherapy with fixed duration, followed by combination sonrotoclax with zanubrutinib at protocol-defined ramp-up schedules until target daily dose will be reached.
Sonrotoclax
Administered orally
Zanubrutinib
Administered orally
Part 2: Schedule Expansion
Participants will receive zanubrutinib monotherapy with fixed duration, followed by combination sonrotoclax with zanubrutinib at ramp-up schedules as determined in Part 1.
Sonrotoclax
Administered orally
Zanubrutinib
Administered orally
Interventions
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Sonrotoclax
Administered orally
Zanubrutinib
Administered orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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 effective method of birth control and refrain from egg donation for the duration of the study and for ≥ 90 days after the last dose of sonrotoclax or ≥ 30 days after the last dose of zanubrutinib, whichever is later.
4. Confirmed diagnosis of CLL, based on Hallek et al 2018, and requiring treatment due to certain features of their disease
5. At least 1 measurable lesion based on computed tomography (CT)/magnetic resonance imaging (MRI) and no history of prolymphocytic leukemia or Richter's transformation.
Exclusion Criteria
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 study treatment
5. Prior systemic treatment for the CLL
6. Uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia requiring treatment
18 Years
ALL
No
Sponsors
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BeiGene
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
BeiGene
Locations
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Moffitt Cancer Center
Tampa, Florida, United States
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, United States
The University of Kansas Cancer Center
Westwood, Kansas, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Washington University School of Medicine
St Louis, Missouri, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Blacktown Cancer and Haematology Centre
Blacktown, New South Wales, Australia
Genesiscare St Andrews
Adelaide, South Australia, Australia
Cabrini Hospital Malvern
Malvern East, Victoria, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Rockingham Hospital
Cooloongup, Western Australia, Australia
Linear Clinical Research
Nedlands, Western Australia, Australia
Chu Dijon
Dijon, , France
Chu Montpellier Hopital Saint Eloi
Montpellier, , France
Iuct Oncopole
Toulouse, , France
Queen Elizabeth Hospital
Birmingham, , United Kingdom
St Jamess University Hospital
Leeds, , United Kingdom
Countries
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Other Identifiers
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BGB-11417-108
Identifier Type: -
Identifier Source: org_study_id