A Study to Investigate Efficacy and Safety of BCL2 Inhibitor Sonrotoclax as Monotherapy and in Combination With Zanubrutinib in Adults With Waldenström Macroglobulinemia
An Open-Label, Multicenter Phase 2 Study to Evaluate the Efficacy and Safety of the BCL2 Inhibitor Sonrotoclax (BGB-11417) as Monotherapy and in Combination With Zanubrutinib (BGB-3111) in Patients With Waldenström Macroglobulinemia
4 other identifiers
interventional
114
9 countries
72
Brief Summary
This study will evaluate the safety and efficacy of the BCL2 inhibitor sonrotoclax (BGB-11417) in participants with relapsed/refractory Waldenström's Macroglobulinemia (R/R WM) and in combination with zanubrutinib in adult participants with previously untreated WM.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2023
Longer than P75 for phase_2
72 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 11, 2023
CompletedFirst Posted
Study publicly available on registry
July 19, 2023
CompletedStudy Start
First participant enrolled
October 23, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 22, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2028
January 2, 2026
December 1, 2025
2.9 years
July 11, 2023
December 30, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cohort 1: Major Response Rate (MRR)
MRR is defined as the percentage of participants achieving partial response (PR) or better, as assessed by the Independent Review Committee (IRC) per the 11th International Workshop on Waldenström Macroglobulinemia (IWWM-11) WM response criteria.
Up to approximately 4 years
Secondary Outcomes (17)
Cohorts 2 and 3: MRR as assessed by the IRC
Up to approximately 5 years
All Cohorts: MRR as assessed by the Investigator
Up to approximately 5 years
Cohorts 1, 2, and 3: Duration of Major Response (DoMR) as assessed by the IRC
Up to approximately 5 years
All Cohorts: DoMR as assessed by the Investigator
Up to approximately 5 years
Cohorts 1, 2, and 3: Complete Response (CR) + Very Good Partial Response (VGPR) as assessed by the IRC
Up to approximately 5 years
- +12 more secondary outcomes
Study Arms (4)
Cohort 1
EXPERIMENTALParticipants 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.
Cohort 2
EXPERIMENTALParticipants 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.
Cohort 3
EXPERIMENTALParticipants 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.
Cohort 4
EXPERIMENTALParticipants with previously untreated WM will receive sonrotoclax and zanubrutinib combination therapy for a fixed duration.
Interventions
Administered orally as a tablet.
Eligibility Criteria
You may qualify if:
- Clinical and definitive histologic diagnosis of WM.
- 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.
You may not qualify if:
- Central nervous system (CNS) involvement by WM.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BeOne Medicineslead
Study Sites (72)
City of Hope National Medical Center
Duarte, California, 91010-3012, United States
Colorado Blood Cancer Institute
Denver, Colorado, 80218, United States
Medstar Georgetown University Hospital
Washington D.C., District of Columbia, 20007-2113, United States
University of Miami
Miami, Florida, 33136-2107, United States
Northwestern Medicine Cancer Center
Warrenville, Illinois, 60555-3269, United States
Mission Cancer and Blood
Waukee, Iowa, 50263, United States
University of Maryland Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, 21201-1544, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215-5418, United States
Mayo Clinic Rochester
Rochester, Minnesota, 55905-0001, United States
Hattiesburg Hematology and Oncology Clinic
Hattiesburg, Mississippi, 39401-7233, United States
Memorial Sloan Kettering Cancer Center Mskcc
New York, New York, 10065-6800, United States
Atrium Health Levine Cancer Institute (Lci)
Charlotte, North Carolina, 28204-2990, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210-1280, United States
Ut Southwestern Medical Center
Dallas, Texas, 75390-7208, United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112-5550, United States
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, 23298, United States
University of Washington
Seattle, Washington, 98195, United States
Concord Repatriation General Hospital
Concord, New South Wales, NSW 2139, Australia
Genesiscare North Shore
St Leonards, New South Wales, NSW 2065, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, QLD 4102, Australia
Flinders Medical Centre
Bedford PK, South Australia, SA 5042, Australia
Monash Health
Clayton, Victoria, VIC 3168, Australia
St Vincents Hospital Melbourne
Fitzroy, Victoria, VIC 3065, Australia
Linear Clinical Research
Nedlands, Western Australia, WA 6009, Australia
Royal Perth Hospital
Perth, Western Australia, WA 6000, Australia
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
Lions Gate Hospital Chemotherapy Clinic
North Vancouver, British Columbia, V7L 2L7, Canada
Qeii Health Science Center
Halifax, Nova Scotia, B3H 2Y9, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9, Canada
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361003, China
Guangdong Provincial Peoples Hospital
Guangzhou, Guangdong, 510080, China
Henan Cancer Hospital
Zhengzhou, Henan, 450000, China
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, 430030, China
Yancheng First Peoples Hospital
Yancheng, Jiangsu, 224006, China
Shengjing Hospital of China Medical Universityshenbei Branch
Shenyang, Liaoning, 110134, China
The Affiliated Hospital of Qingdao University Branch South
Qingdao, Shandong, 266000, China
Affiliated Zhongshan Hospital of Fudan University
Shanghai, Shanghai Municipality, 200032, China
The Third Peoples Hospital of Datong
Datong, Shanxi, 037008, China
Institute of Hematology and Hospital of Blood Disease
Tianjin, Tianjin Municipality, 300020, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003, China
The First Hospital of Jiaxing
Jiaxing, Zhejiang, 314001, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000, China
Centre Hospitalier Universitaire Damiens Hopital Sud
Amiens, 80054, France
Chu Clermont Ferrand Therapie Cellulaire and Hematolo
Clermontferrand, 63100, France
Institut Paoli Calmettes
Marseille, 13009, France
Hopital de La Pitie Salpetriere
Paris, 75013, France
Chu Hopital Lyon Sud
PierreBenite, 69495, France
Hopital Robert Debre
Reims, 51100, France
General Hospital of Athens Alexandra
Athens, 115 28, Greece
Irccs Azienda Ospedaliero Universitaria Bologna
Bologna, 40138, Italy
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Brescia, 25123, Italy
Istituto Europeo Di Oncologia
Milan, 20141, Italy
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
Milan, 20162, Italy
Irccs Policlinico San Matteo, Universita Degli Studi Di Pavi
Pavia, 27100, Italy
Fondazione Policlinico Universitario Agostino Gemelli
Roma, 00168, Italy
Azienda Sanitaria Universitaria Friuli Centrale Presidio Ospedaliero Universitario Santa Maria Del
Udine, 33100, Italy
Hospital Universitario Vall Dhebron
Barcelona, 08035, Spain
Institut Catala Doncologia
Barcelona, 08908, Spain
Hospital Clinic de Barcelona
Barcelona, 8036, Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, 28040, Spain
Hospital Universitario de Salamanca
Salamanca, 37007, Spain
Hospital Universitario Virgen Del Rocio
Seville, 41013, Spain
Hospital Universitari Mutua Terrassa
Terrassa, 8221, Spain
University Hospitals Dorset
Bournemouth, BH7 7DW, United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, G12 0YN, United Kingdom
Churchill Hospital Oxford University Hospital Nhs Trust
Headington, OX3 7LE, United Kingdom
Nhs Highland
Inverness, IV2 3BW, United Kingdom
St Jamess University Hospital
Leeds, LS9 7TF, United Kingdom
University College Hospital
London, NW1 2PG, United Kingdom
The Christie Nhs Foundation Trust Manchester
Manchester, M20 4BX, United Kingdom
Plymouth Hospitals Nhs Trust
Plymouth, PL6 8DH, United Kingdom
Royal Marsden Nhs Foundation Royal Marsden Hospital
Sutton, SM2 5PT, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
BeOne Medicines
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 11, 2023
First Posted
July 19, 2023
Study Start
October 23, 2023
Primary Completion (Estimated)
September 22, 2026
Study Completion (Estimated)
August 1, 2028
Last Updated
January 2, 2026
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- See plan description
- Access Criteria
- See plan description
BeOne shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved. BeOne shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations. Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.