A Study to Investigate Efficacy and Safety of BCL2 Inhibitor Sonrotoclax as Monotherapy and in Combination With Zanubrutinib in Adults With Waldenström Macroglobulinemia

Last updated: November 20, 2025
Sponsor: BeOne Medicines
Overall Status: Active - Not Recruiting

Phase

2

Condition

Lymphoma

Leukemia

Lymphoproliferative Disorders

Treatment

Sonrotoclax

BGB-11417

Zanubrutinib

Clinical Study ID

NCT05952037
BGB-11417-203
2023-503235-18-00
U1111-1291-4524
2023-503235-18
CTR20232718
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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 participantshad intolerance to the most recent therapy. Refractory disease is defined as notattaining at least a major response, or progressing while on or within 6 months ofcompleting therapy. Relapsed disease is defined as attaining at least a majorresponse to therapy and meeting the criteria for disease progression beyond 6 monthsafter completing therapy.

  • For Cohort 4, patients must not have received prior therapy for WM (except forplasmapheresis).

  • Adequate organ function.

Exclusion

Exclusion Criteria:

  • 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 parenteralantimicrobial therapy that was completed ≤ 14 days before the first dose of thestudy drug.

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

Study Design

Total Participants: 114
Treatment Group(s): 3
Primary Treatment: Sonrotoclax
Phase: 2
Study Start date:
September 28, 2023
Estimated Completion Date:
August 31, 2028

Study Description

This study will test whether sonrotoclax (BGB-11417) can be used to improve outcomes in participants with Waldenström's Macroglobulinemia (WM) both when used alone in those who have not responded well to conventional treatments and when used in combination with zanubrutinib in those who have not yet received treatment. The main goals of the study are to determine how many participants no longer have evidence of cancer or have some improvement in the signs and symptoms of cancer after treatment, and to determine what adverse events, or side effects, participants might experience.

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.

Connect with a study center

  • Concord Repatriation General Hospital

    Concord, New South Wales 2139
    Australia

    Site Not Available

  • Genesiscare North Shore

    St Leonards, New South Wales 2065
    Australia

    Site Not Available

  • Concord Repatriation General Hospital

    Concord 2170852, New South Wales 2155400 NSW 2139
    Australia

    Site Not Available

  • Genesiscare North Shore

    St Leonards 8029783, New South Wales 2155400 NSW 2065
    Australia

    Site Not Available

  • Princess Alexandra Hospital

    Brisbane, Queensland 4102
    Australia

    Site Not Available

  • Princess Alexandra Hospital

    Woolloongabba, Queensland 4102
    Australia

    Site Not Available

  • Princess Alexandra Hospital

    Woolloongabba 6943568, Queensland 2152274 QLD 4102
    Australia

    Site Not Available

  • Flinders Medical Centre

    Bedford PK, South Australia 2061327 SA 5042
    Australia

    Site Not Available

  • Monash Health

    Clayton, Victoria 3168
    Australia

    Site Not Available

  • St Vincents Hospital Melbourne

    Fitzroy, Victoria 3065
    Australia

    Site Not Available

  • Monash Health

    Clayton 2171400, Victoria 2145234 VIC 3168
    Australia

    Site Not Available

  • St Vincents Hospital Melbourne

    Fitzroy 2166584, Victoria 2145234 VIC 3065
    Australia

    Site Not Available

  • Linear Clinical Research

    Nedlands, Western Australia 6009
    Australia

    Site Not Available

  • Royal Perth Hospital

    Perth, Western Australia 6000
    Australia

    Site Not Available

  • Linear Clinical Research

    Nedlands 2064874, Western Australia 2058645 WA 6009
    Australia

    Site Not Available

  • Royal Perth Hospital

    Perth 2063523, Western Australia 2058645 WA 6000
    Australia

    Site Not Available

  • Cross Cancer Institute

    Edmonton, Alberta T6G 1Z2
    Canada

    Site Not Available

  • Cross Cancer Institute

    Edmonton 5946768, Alberta 5883102 T6G 1Z2
    Canada

    Site Not Available

  • Lions Gate Hospital Chemotherapy Clinic

    North Vancouver, British Columbia V7L 2L7
    Canada

    Site Not Available

  • Lions Gate Hospital Chemotherapy Clinic

    North Vancouver 6090785, British Columbia 5909050 V7L 2L7
    Canada

    Site Not Available

  • Qeii Health Science Center

    Halifax, Nova Scotia B3H 2Y9
    Canada

    Site Not Available

  • Qeii Health Science Center

    Halifax 6324729, Nova Scotia 6091530 B3H 2Y9
    Canada

    Site Not Available

  • Princess Margaret Cancer Centre

    Toronto, Ontario M5G 2M9
    Canada

    Site Not Available

  • Princess Margaret Cancer Centre

    Toronto 6167865, Ontario 6093943 M5G 2M9
    Canada

    Site Not Available

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian 361003
    China

    Site Not Available

  • The First Affiliated Hospital of Xiamen University

    Xiamen 1790645, Fujian 1811017 361003
    China

    Site Not Available

  • Guangdong Provincial Peoples Hospital

    Guangzhou, Guangdong 510080
    China

    Site Not Available

  • Guangdong Provincial Peoples Hospital

    Guangzhou 1809858, Guangdong 1809935 510080
    China

    Site Not Available

  • Henan Cancer Hospital

    Zhengzhou, Henan 450000
    China

    Site Not Available

  • Henan Cancer Hospital

    Zhengzhou 1784658, Henan 1808520 450000
    China

    Site Not Available

  • Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei 430030
    China

    Site Not Available

  • Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology

    Wuhan 1791247, Hubei 1806949 430030
    China

    Site Not Available

  • Yancheng First Peoples Hospital

    Yancheng, Jiangsu 224006
    China

    Site Not Available

  • Yancheng First Peoples Hospital

    Yancheng 1787746, Jiangsu 1806260 224006
    China

    Site Not Available

  • Shengjing Hospital Affiliated of China Medical University

    Shenyang, Liaoning 110022
    China

    Active - Recruiting

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning 110004
    China

    Active - Recruiting

  • Shengjing Hospital of China Medical Universityshenbei Branch

    Shenyang, Liaoning 110134
    China

    Site Not Available

  • Shengjing Hospital of China Medical Universityshenbei Branch

    Shenyang 2034937, Liaoning 2036115 110134
    China

    Site Not Available

  • The Affiliated Hospital of Qingdao University Branch South

    Qingdao, Shandong 266000
    China

    Site Not Available

  • The Affiliated Hospital of Qingdao University Branch South

    Qingdao 1797929, Shandong 1796328 266000
    China

    Site Not Available

  • Affiliated Zhongshan Hospital of Fudan University

    Shanghai, Shanghai 200032
    China

    Site Not Available

  • Affiliated Zhongshan Hospital of Fudan University

    Shanghai 1796236, Shanghai Municipality 1796231 200032
    China

    Site Not Available

  • The Third Peoples Hospital of Datong

    Datong, Shanxi 037008
    China

    Site Not Available

  • The Third Peoples Hospital of Datong

    Datong 2037799, Shanxi 1795912 037008
    China

    Site Not Available

  • Institute of Hematology and Hospital of Blood Disease

    Tianjin, Tianjin 300020
    China

    Site Not Available

  • Institute of Hematology and Hospital of Blood Disease

    Tianjin 1792947, Tianjin Municipality 1792943 300020
    China

    Site Not Available

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang 310003
    China

    Site Not Available

  • The First Hospital of Jiaxing

    Jiaxing, Zhejiang 314001
    China

    Site Not Available

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang 325000
    China

    Site Not Available

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou 1808926, Zhejiang 1784764 310003
    China

    Site Not Available

  • The First Hospital of Jiaxing

    Jiaxing 1805953, Zhejiang 1784764 314001
    China

    Site Not Available

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou 1791388, Zhejiang 1784764 325000
    China

    Site Not Available

  • Centre Hospitalier Universitaire Damiens Hopital Sud

    Amiens 3037854, 80054
    France

    Site Not Available

  • Centre Hospitalier Universitaire Damiens Hopital Sud

    Amiens Cedex, 80054
    France

    Site Not Available

  • Chu Clermont Ferrand Therapie Cellulaire and Hematolo

    Clermont Ferrand, 63003
    France

    Site Not Available

  • Chu Clermont Ferrand Therapie Cellulaire and Hematolo

    Clermontferrand, 63100
    France

    Site Not Available

  • Institut Paoli Calmettes

    Marseille, 13009
    France

    Site Not Available

  • Institut Paoli Calmettes

    Marseille 2995469, 13009
    France

    Site Not Available

  • Hopital de La Pitie Salpetriere

    Paris, 75013
    France

    Site Not Available

  • Hopital de La Pitie Salpetriere

    Paris 2988507, 75013
    France

    Site Not Available

  • Chu Hopital Lyon Sud

    PierreBenite, 69495
    France

    Site Not Available

  • Hopital Robert Debre

    Reims, 51100
    France

    Site Not Available

  • Hopital Robert Debre

    Reims 2984114, 51100
    France

    Site Not Available

  • Hopital Robert Debre

    Reims Cedex, 51056
    France

    Site Not Available

  • General Hospital of Athens Alexandra

    Athens, 115 28
    Greece

    Site Not Available

  • General Hospital of Athens Alexandra

    Athens 264371, 115 28
    Greece

    Site Not Available

  • Irccs Azienda Ospedaliero Universitaria Bologna

    Bologna, 40138
    Italy

    Site Not Available

  • Irccs Azienda Ospedaliero Universitaria Bologna

    Bologna 3181928, 40138
    Italy

    Site Not Available

  • Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia

    Brescia, 25123
    Italy

    Site Not Available

  • Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia

    Brescia 3181554, 25123
    Italy

    Site Not Available

  • Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

    Milan 6951411, 20162
    Italy

    Site Not Available

  • Istituto Europeo Di Oncologia

    Milan 6951411, 20141
    Italy

    Site Not Available

  • Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

    Milano, 20162
    Italy

    Active - Recruiting

  • Istituto Europeo Di Oncologia

    Milano, 20141
    Italy

    Site Not Available

  • Irccs Policlinico San Matteo, Universita Degli Studi Di Pavi

    Pavia, 27100
    Italy

    Site Not Available

  • Irccs Policlinico San Matteo, Universita Degli Studi Di Pavi

    Pavia 3171366, 27100
    Italy

    Site Not Available

  • Fondazione Policlinico Universitario Agostino Gemelli

    Roma, 00168
    Italy

    Site Not Available

  • Fondazione Policlinico Universitario Agostino Gemelli

    Roma 8957247, 00168
    Italy

    Site Not Available

  • Azienda Sanitaria Universitaria Friuli Centrale Presidio Ospedaliero Universitario Santa Maria Del

    Udine, 33100
    Italy

    Site Not Available

  • Azienda Sanitaria Universitaria Friuli Centrale Presidio Ospedaliero Universitario Santa Maria Del

    Udine 3165072, 33100
    Italy

    Site Not Available

  • Hospital Clinic de Barcelona

    Barcelona, 8036
    Spain

    Active - Recruiting

  • Hospital Universitario Vall Dhebron

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Institut Catala Doncologia

    Barcelona, 08908
    Spain

    Site Not Available

  • Hospital Clinic de Barcelona

    Barcelona 3128760, 8036
    Spain

    Site Not Available

  • Hospital Universitario Vall Dhebron

    Barcelona 3128760, 08035
    Spain

    Site Not Available

  • Institut Catala Doncologia

    Barcelona 3128760, 08908
    Spain

    Site Not Available

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040
    Spain

    Site Not Available

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid 3117735, 28040
    Spain

    Site Not Available

  • Hospital Universitario de Salamanca

    Salamanca, 37007
    Spain

    Site Not Available

  • Hospital Universitario de Salamanca

    Salamanca 3111108, 37007
    Spain

    Site Not Available

  • Hospital Universitario Virgen Del Rocio

    Sevilla, 41013
    Spain

    Site Not Available

  • Hospital Universitario Virgen Del Rocio

    Seville 2510911, 41013
    Spain

    Site Not Available

  • Hospital Universitari Mutua Terrassa

    Terassa, 8221
    Spain

    Site Not Available

  • Hospital Universitari Mutua Terrassa

    Terrassa, 8221
    Spain

    Site Not Available

  • Hospital Universitari Mutua Terrassa

    Terrassa 3108286, 8221
    Spain

    Site Not Available

  • University Hospitals Dorset

    Bournemouth, BH7 7DW
    United Kingdom

    Site Not Available

  • University Hospitals Dorset

    Bournemouth 2655095, BH7 7DW
    United Kingdom

    Site Not Available

  • Beatson West of Scotland Cancer Centre

    Glasgow, G12 0YN
    United Kingdom

    Site Not Available

  • Beatson West of Scotland Cancer Centre

    Glasgow 2648579, G12 0YN
    United Kingdom

    Site Not Available

  • Churchill Hospital Oxford University Hospital Nhs Trust

    Headington, OX3 7LE
    United Kingdom

    Site Not Available

  • Churchill Hospital Oxford University Hospital Nhs Trust

    Headington 2647239, OX3 7LE
    United Kingdom

    Site Not Available

  • Nhs Highland

    Inverness, IV2 3BW
    United Kingdom

    Site Not Available

  • Nhs Highland

    Inverness 2646088, IV2 3BW
    United Kingdom

    Site Not Available

  • St Jamess University Hospital

    Leeds, LS9 7TF
    United Kingdom

    Site Not Available

  • St Jamess University Hospital

    Leeds 2644688, LS9 7TF
    United Kingdom

    Site Not Available

  • University College Hospital

    London, NW1 2PG
    United Kingdom

    Site Not Available

  • University College Hospital

    London 2643743, NW1 2PG
    United Kingdom

    Site Not Available

  • The Christie Nhs Foundation Trust Manchester

    Manchester, M20 4BX
    United Kingdom

    Site Not Available

  • The Christie Nhs Foundation Trust Manchester

    Manchester 2643123, M20 4BX
    United Kingdom

    Site Not Available

  • Plymouth Hospitals Nhs Trust

    Plymouth, PL6 8DH
    United Kingdom

    Site Not Available

  • Plymouth Hospitals Nhs Trust

    Plymouth 2640194, PL6 8DH
    United Kingdom

    Site Not Available

  • Royal Marsden Nhs Foundation Royal Marsden Hospital

    Sutton, SM2 5PT
    United Kingdom

    Site Not Available

  • Royal Marsden Nhs Foundation Royal Marsden Hospital

    Sutton 2636503, SM2 5PT
    United Kingdom

    Site Not Available

  • City of Hope National Medical Center

    Duarte, California 91010-3012
    United States

    Site Not Available

  • City of Hope National Medical Center

    Duarte 5344147, California 5332921 91010-3012
    United States

    Site Not Available

  • Colorado Blood Cancer Institute

    Denver, Colorado 80218
    United States

    Site Not Available

  • Colorado Blood Cancer Institute

    Denver 5419384, Colorado 5417618 80218
    United States

    Site Not Available

  • Medstar Georgetown University Hospital

    Washington, District of Columbia 20007-2113
    United States

    Site Not Available

  • Medstar Georgetown University Hospital

    Washington D.C. 4140963, District of Columbia 4138106 20007-2113
    United States

    Site Not Available

  • University of Miami

    Miami, Florida 33136-2107
    United States

    Site Not Available

  • University of Miami

    Miami 4164138, Florida 4155751 33136-2107
    United States

    Site Not Available

  • Northwestern Medicine Cancer Center

    Warrenville, Illinois 60555-3269
    United States

    Site Not Available

  • Northwestern Medicine Cancer Center

    Warrenville 4915525, Illinois 4896861 60555-3269
    United States

    Site Not Available

  • Mission Cancer and Blood

    Des Moines, Iowa 50309
    United States

    Site Not Available

  • Mission Cancer and Blood

    Waukee, Iowa 50263
    United States

    Site Not Available

  • Mission Cancer and Blood

    Waukee 4880981, Iowa 4862182 50263
    United States

    Site Not Available

  • University of Maryland Greenebaum Comprehensive Cancer Center

    Baltimore, Maryland 21201-1544
    United States

    Site Not Available

  • University of Maryland Greenebaum Comprehensive Cancer Center

    Baltimore 4347778, Maryland 4361885 21201-1544
    United States

    Site Not Available

  • Dana Farber Cancer Institute

    Boston, Massachusetts 02215-5418
    United States

    Site Not Available

  • Dana-Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • Dana Farber Cancer Institute

    Boston 4930956, Massachusetts 6254926 02215-5418
    United States

    Site Not Available

  • Mayo Clinic Rochester

    Rochester, Minnesota 55905-0001
    United States

    Site Not Available

  • Mayo Clinic Rochester

    Rochester 5043473, Minnesota 5037779 55905-0001
    United States

    Site Not Available

  • Hattiesburg Hematology and Oncology Clinic

    Hattiesburg, Mississippi 39401-7233
    United States

    Site Not Available

  • Hattiesburg Hematology and Oncology Clinic

    Hattiesburg 4429295, Mississippi 4436296 39401-7233
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center Mskcc

    New York, New York 10065-6800
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center Mskcc

    New York 5128581, New York 5128638 10065-6800
    United States

    Site Not Available

  • Atrium Health Levine Cancer Institute (Lci)

    Charlotte, North Carolina 28204-2990
    United States

    Site Not Available

  • Atrium Health Levine Cancer Institute (Lci)

    Charlotte 4460243, North Carolina 4482348 28204-2990
    United States

    Site Not Available

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio 43210-1280
    United States

    Site Not Available

  • Ohio State University Comprehensive Cancer Center

    Columbus 4509177, Ohio 5165418 43210-1280
    United States

    Site Not Available

  • Ut Southwestern Medical Center

    Dallas, Texas 75390-7208
    United States

    Site Not Available

  • Ut Southwestern Medical Center

    Dallas 4684888, Texas 4736286 75390-7208
    United States

    Site Not Available

  • Huntsman Cancer Institute

    Salt Lake City, Utah 84112-5550
    United States

    Site Not Available

  • Huntsman Cancer Institute

    Salt Lake City 5780993, Utah 5549030 84112-5550
    United States

    Site Not Available

  • Virginia Commonwealth University Massey Cancer Center

    Richmond, Virginia 23298
    United States

    Site Not Available

  • Virginia Commonwealth University Massey Cancer Center

    Richmond 4781708, Virginia 6254928 23298
    United States

    Site Not Available

  • University of Washington

    Seattle, Washington 98195
    United States

    Site Not Available

  • University of Washington

    Seattle 5809844, Washington 5815135 98195
    United States

    Site Not Available

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