A Study to Investigate Efficacy and Safety of BCL2 Inhibitor Sonrotoclax as Monotherapy and in Combination With Zanubrutinib in Adults With Waldenström Macroglobulinemia
NCT ID: NCT05952037
Last Updated: 2025-11-12
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2
105 participants
INTERVENTIONAL
2023-09-28
2028-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
BCL2 is a key protein involved in cell death, and abnormal levels of BCL2 are associated with many cancers. Blocking the action of BCL2 proteins is a promising approach with potential therapeutic benefits in participants with different types of cancers, including WM. This study will enroll approximately 105 participants. All participants will receive sonrotoclax orally as a tablet.
The study will take place at multiple centers worldwide. The overall time to participate in this study is approximately 5 years.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Cohort 1
Participants with R/R disease to both Bruton tyrosine kinase (BTK) inhibitor and anti-CD20 antibody-based systemic therapy containing chemotherapy or proteasome inhibitor will receive sonrotoclax at a standard dose, given orally once daily.
Sonrotoclax
Administered orally as a tablet.
Cohort 2
Participants with R/R disease to anti-CD20 antibody-based systemic therapy containing chemotherapy or proteasome inhibitor and were intolerant to BTK inhibitor will receive sonrotoclax at a standard dose, given orally once daily.
Sonrotoclax
Administered orally as a tablet.
Cohort 3
Participants with R/R disease to a BTK inhibitor treatment and are unsuitable for chemoimmunotherapy will receive sonrotoclax at a standard dose, given orally once daily.
Sonrotoclax
Administered orally as a tablet.
Cohort 4
Participants with previously untreated WM will receive sonrotoclax and zanubrutinib combination therapy for a fixed duration.
Sonrotoclax
Administered orally as a tablet.
Zanubrutinib
Administered orally as a capsule.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Sonrotoclax
Administered orally as a tablet.
Zanubrutinib
Administered orally as a capsule.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Meeting ≥ 1 criterion for treatment according to consensus panel criteria from the 2nd International Workshop on Waldenström's Macroglobulinemia (IWWM).
* For Cohorts 1-3, refractory or relapsed disease at study entry unless participants had intolerance to the most recent therapy. Refractory disease is defined as not attaining at least a major response, or progressing while on or within 6 months of completing therapy. Relapsed disease is defined as attaining at least a major response to therapy and meeting the criteria for disease progression beyond 6 months after completing therapy.
* For Cohort 4, patients must not have received prior therapy for WM (except for plasmapheresis).
* Adequate organ function.
Exclusion Criteria
* Transformation to aggressive lymphoma, such as diffuse large B-cell lymphoma.
* History of other malignancies ≤ 2 years before study entry.
* Uncontrolled active systemic infection or recent infection requiring parenteral antimicrobial therapy that was completed ≤ 14 days before the first dose of the study drug.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
BeOne Medicines
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Study Director
Role: STUDY_DIRECTOR
BeOne Medicines
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
City of Hope National Medical Center
Duarte, California, United States
Colorado Blood Cancer Institute
Denver, Colorado, United States
Medstar Georgetown University Hospital
Washington D.C., District of Columbia, United States
University of Miami
Miami, Florida, United States
Northwestern Medicine Cancer Center
Warrenville, Illinois, United States
Mission Cancer and Blood
Waukee, Iowa, United States
University of Maryland Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Hattiesburg Hematology and Oncology Clinic
Hattiesburg, Mississippi, United States
Memorial Sloan Kettering Cancer Center Mskcc
New York, New York, United States
Atrium Health Levine Cancer Institute (Lci)
Charlotte, North Carolina, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Ut Southwestern Medical Center
Dallas, Texas, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, United States
University of Washington
Seattle, Washington, United States
Concord Repatriation General Hospital
Concord, New South Wales, Australia
Genesiscare North Shore
St Leonards, New South Wales, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Flinders Medical Centre
Bedford PK, South Australia, Australia
Monash Health
Clayton, Victoria, Australia
St Vincents Hospital Melbourne
Fitzroy, Victoria, Australia
Linear Clinical Research
Nedlands, Western Australia, Australia
Royal Perth Hospital
Perth, Western Australia, Australia
Cross Cancer Institute
Edmonton, Alberta, Canada
Lions Gate Hospital Chemotherapy Clinic
North Vancouver, British Columbia, Canada
Qeii Health Science Center
Halifax, Nova Scotia, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Guangdong Provincial Peoples Hospital
Guangzhou, Guangdong, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
Yancheng First Peoples Hospital
Yancheng, Jiangsu, China
Shengjing Hospital of China Medical Universityshenbei Branch
Shenyang, Liaoning, China
The Affiliated Hospital of Qingdao University Branch South
Qingdao, Shandong, China
Affiliated Zhongshan Hospital of Fudan University
Shanghai, Shanghai Municipality, China
The Third Peoples Hospital of Datong
Datong, Shanxi, China
Institute of Hematology and Hospital of Blood Disease
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
The First Hospital of Jiaxing
Jiaxing, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Centre Hospitalier Universitaire Damiens Hopital Sud
Amiens, , France
Chu Clermont Ferrand Therapie Cellulaire and Hematolo
Clermontferrand, , France
Institut Paoli Calmettes
Marseille, , France
Hopital de La Pitie Salpetriere
Paris, , France
Chu Hopital Lyon Sud
PierreBenite, , France
Hopital Robert Debre
Reims, , France
General Hospital of Athens Alexandra
Athens, , Greece
Irccs Azienda Ospedaliero Universitaria Bologna
Bologna, , Italy
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Brescia, , Italy
Istituto Europeo Di Oncologia
Milan, , Italy
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
Milan, , Italy
Irccs Policlinico San Matteo, Universita Degli Studi Di Pavi
Pavia, , Italy
Fondazione Policlinico Universitario Agostino Gemelli
Roma, , Italy
Azienda Sanitaria Universitaria Friuli Centrale Presidio Ospedaliero Universitario Santa Maria Del
Udine, , Italy
Hospital Universitario Vall Dhebron
Barcelona, , Spain
Institut Catala Doncologia
Barcelona, , Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, , Spain
Hospital Universitario de Salamanca
Salamanca, , Spain
Hospital Universitario Virgen Del Rocio
Seville, , Spain
Hospital Universitari Mutua Terrassa
Terrassa, , Spain
University Hospitals Dorset
Bournemouth, , United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, , United Kingdom
Churchill Hospital Oxford University Hospital Nhs Trust
Headington, , United Kingdom
Nhs Highland
Inverness, , United Kingdom
St Jamess University Hospital
Leeds, , United Kingdom
University College Hospital
London, , United Kingdom
The Christie Nhs Foundation Trust Manchester
Manchester, , United Kingdom
Plymouth Hospitals Nhs Trust
Plymouth, , United Kingdom
Royal Marsden Nhs Foundation Royal Marsden Hospital
Sutton, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
U1111-1291-4524
Identifier Type: REGISTRY
Identifier Source: secondary_id
CTR20232718
Identifier Type: REGISTRY
Identifier Source: secondary_id
2023-503235-18-00
Identifier Type: CTIS
Identifier Source: secondary_id
BGB-11417-203
Identifier Type: -
Identifier Source: org_study_id