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A Phase 1/2 Open-label Study to Investigate the Safety of Sonrotoclax Ramp-up Schedule(s) in Adult Patients With Hematological Malignancies.
The purpose of this study is to establish the safety of novel dosing and ramp-up schedules for sonrotoclax in participants with hematological malignancies.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
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
Start Date
January 23, 2025
Primary Completion Date
June 1, 2027
Completion Date
December 31, 2027
Last Updated
December 17, 2025
56
ESTIMATED participants
Sonrotoclax
DRUG
Zanubrutinib
DRUG
Lead Sponsor
BeiGene
NCT05006716
NCT07277231
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06859424