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AzTrials

Waldenstrom MacroglobulinemiaPhase 2NCT05952037

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

A Phase 2 study testing Sonrotoclax and Zanubrutinib in people with Waldenstrom Macroglobulinemia and Waldenstrom's Macroglobulinemia Recurrent, run by BeOne Medicines at 72 sites in 9 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Sonrotoclax and Zanubrutinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
114 participants
Where
72 sitesin 9 countries
Study dates
23 Oct 2023to Aug 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

72 sites in 9 countries.

72 sites in 9 countries

United States17 sites

  • University of Maryland Greenebaum Comprehensive Cancer Center

    Baltimore, Maryland, 21201-1544

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215-5418

  • Atrium Health Levine Cancer Institute (Lci)

    Charlotte, North Carolina, 28204-2990

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210-1280

  • Ut Southwestern Medical Center

    Dallas, Texas, 75390-7208

  • Colorado Blood Cancer Institute

    Denver, Colorado, 80218

  • City of Hope National Medical Center

    Duarte, California, 91010-3012

  • Hattiesburg Hematology and Oncology Clinic

    Hattiesburg, Mississippi, 39401-7233

  • University of Miami

    Miami, Florida, 33136-2107

  • Memorial Sloan Kettering Cancer Center Mskcc

    New York, New York, 10065-6800

  • Virginia Commonwealth University Massey Cancer Center

    Richmond, Virginia, 23298

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905-0001

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112-5550

  • University of Washington

    Seattle, Washington, 98195

  • Northwestern Medicine Cancer Center

    Warrenville, Illinois, 60555-3269

  • Medstar Georgetown University Hospital

    Washington D.C., District of Columbia, 20007-2113

  • Mission Cancer and Blood

    Waukee, Iowa, 50263

Other trials in United States

China13 sites

  • The Third Peoples Hospital of Datong

    Datong, Shanxi, 037008

  • Guangdong Provincial Peoples Hospital

    Guangzhou, Guangdong, 510080

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003

  • The First Hospital of Jiaxing

    Jiaxing, Zhejiang, 314001

  • The Affiliated Hospital of Qingdao University Branch South

    Qingdao, Shandong, 266000

  • Affiliated Zhongshan Hospital of Fudan University

    Shanghai, Shanghai Municipality, 200032

  • Shengjing Hospital of China Medical Universityshenbei Branch

    Shenyang, Liaoning, 110134

  • Institute of Hematology and Hospital of Blood Disease

    Tianjin, Tianjin Municipality, 300020

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325000

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

    Wuhan, Hubei, 430030

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian, 361003

  • Yancheng First Peoples Hospital

    Yancheng, Jiangsu, 224006

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450000

Other trials in China

United Kingdom9 sites

  • University Hospitals Dorset

    Bournemouth, BH7 7DW

  • Beatson West of Scotland Cancer Centre

    Glasgow, G12 0YN

  • Churchill Hospital Oxford University Hospital Nhs Trust

    Headington, OX3 7LE

  • Nhs Highland

    Inverness, IV2 3BW

  • St Jamess University Hospital

    Leeds, LS9 7TF

  • University College Hospital

    London, NW1 2PG

  • The Christie Nhs Foundation Trust Manchester

    Manchester, M20 4BX

  • Plymouth Hospitals Nhs Trust

    Plymouth, PL6 8DH

  • Royal Marsden Nhs Foundation Royal Marsden Hospital

    Sutton, SM2 5PT

Other trials in United Kingdom

Australia8 sites

  • Flinders Medical Centre

    Bedford PK, South Australia, SA 5042

  • Monash Health

    Clayton, Victoria, VIC 3168

  • Concord Repatriation General Hospital

    Concord, New South Wales, NSW 2139

  • St Vincents Hospital Melbourne

    Fitzroy, Victoria, VIC 3065

  • Linear Clinical Research

    Nedlands, Western Australia, WA 6009

  • Royal Perth Hospital

    Perth, Western Australia, WA 6000

  • Genesiscare North Shore

    St Leonards, New South Wales, NSW 2065

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, QLD 4102

Other trials in Australia

Italy7 sites

  • Irccs Azienda Ospedaliero Universitaria Bologna

    Bologna, 40138

  • Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia

    Brescia, 25123

  • Istituto Europeo Di Oncologia

    Milan, 20141

  • Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

    Milan, 20162

  • Irccs Policlinico San Matteo, Universita Degli Studi Di Pavi

    Pavia, 27100

  • Fondazione Policlinico Universitario Agostino Gemelli

    Roma, 00168

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

    Udine, 33100

Other trials in Italy

Spain7 sites

  • Hospital Universitario Vall Dhebron

    Barcelona, 08035

  • Institut Catala Doncologia

    Barcelona, 08908

  • Hospital Clinic de Barcelona

    Barcelona, 8036

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040

  • Hospital Universitario de Salamanca

    Salamanca, 37007

  • Hospital Universitario Virgen Del Rocio

    Seville, 41013

  • Hospital Universitari Mutua Terrassa

    Terrassa, 8221

Other trials in Spain

France6 sites

  • Centre Hospitalier Universitaire Damiens Hopital Sud

    Amiens, 80054

  • Chu Clermont Ferrand Therapie Cellulaire and Hematolo

    Clermontferrand, 63100

  • Institut Paoli Calmettes

    Marseille, 13009

  • Hopital de La Pitie Salpetriere

    Paris, 75013

  • Chu Hopital Lyon Sud

    PierreBenite, 69495

  • Hopital Robert Debre

    Reims, 51100

Other trials in France

Canada4 sites

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • Qeii Health Science Center

    Halifax, Nova Scotia, B3H 2Y9

  • Lions Gate Hospital Chemotherapy Clinic

    North Vancouver, British Columbia, V7L 2L7

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9

Other trials in Canada

Greece1 site

  • General Hospital of Athens Alexandra

    Athens, 115 28

Other trials in Greece

About this study

Official title: 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

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.

Read the detailed 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.

Note: Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.

Being tested
Sonrotoclax, Zanubrutinib
Keywords
Waldenström's macroglobulinemia, Waldenstrom's Macroglobulinemia Recurrent, Waldenstrom's Macroglobulinemia Refractory, Lymphoma, BGB-11417, BCL-2i
Medical subject headings
Waldenstrom Macroglobulinemia, Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SonrotoclaxDrug

    Also called BGB-11417

    Administered orally as a tablet.

  • ZanubrutinibDrug

    Also called BRUKINSA, BGB-3111

    Administered orally as a capsule.

Study groups in NCT05952037
Study groupRoleWhat they receive
Cohort 1ExperimentalParticipants 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.
Receives: Drug: Sonrotoclax
Cohort 2ExperimentalParticipants 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.
Receives: Drug: Sonrotoclax
Cohort 3ExperimentalParticipants 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.
Receives: Drug: Sonrotoclax
Cohort 4ExperimentalParticipants with previously untreated WM will receive sonrotoclax and zanubrutinib combination therapy for a fixed duration.
Receives: Drug: Sonrotoclax; Drug: Zanubrutinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to approximately 4 years

Secondary outcomes (17)

  1. Cohorts 2 and 3: MRR as assessed by the IRC

    MRR is defined as the percentage of participants achieving PR or better.

    Measured: Up to approximately 5 years

  2. All Cohorts: MRR as assessed by the Investigator

    MRR is defined as the percentage of participants achieving PR or better.

    Measured: Up to approximately 5 years

  3. Cohorts 1, 2, and 3: Duration of Major Response (DoMR) as assessed by the IRC

    DoMR is defined as the time from first determination of major response until first documentation of progression or death, whichever occurs first.

    Measured: Up to approximately 5 years

  4. All Cohorts: DoMR as assessed by the Investigator

    DoMR is defined as the time from first determination of major response until first documentation of progression or death, whichever occurs first.

    Measured: Up to approximately 5 years

  5. Cohorts 1, 2, and 3: Complete Response (CR) + Very Good Partial Response (VGPR) as assessed by the IRC

    CR + VGPR is defined as the percentage of participants who achieve CR or VGPR.

    Measured: Up to approximately 5 years

  6. All Cohorts: CR + VGPR as assessed by the Investigator

    CR + VGPR is defined as the percentage of participants who achieve CR or VGPR.

    Measured: Up to approximately 5 years

  7. Cohorts 1, 2, and 3: Overall Response Rate (ORR) as assessed by the IRC

    ORR is defined as the percentage of participants with minor response (MR) or better.

    Measured: Up to approximately 5 years

  8. All cohorts: ORR as assessed by the investigator

    ORR is defined as the percentage of participants with MR or better.

    Measured: Up to approximately 5 years

  9. Cohorts 1, 2, and 3: Duration of Response (DOR) as assessed by the IRC

    DOR is defined as the time from first determination of response until first documentation of progression or death, whichever occurs first.

    Measured: Up to approximately 5 years

  10. All Cohorts: DOR as assessed by the investigator

    DOR is defined as the time from first determination of response until first documentation of progression or death, whichever occurs first.

    Measured: Up to approximately 5 years

  11. Cohorts 1, 2, and 3: Progression-Free Survival (PFS)

    PFS is defined as the time from first dose until first documentation of progression or death, whichever comes first, as assessed by the IRC and by the investigator.

    Measured: Up to approximately 5 years

  12. Cohorts 1, 2, and 3: Time to major response as assessed by the IRC

    Time to major response is defined as the time from start of study treatment to the first documentation of major response.

    Measured: Up to approximately 5 years

  13. All Cohorts: Time to major response as assessed by the investigator

    Time to major response is defined as the time from start of study treatment to the first documentation of major response.

    Measured: Up to approximately 5 years

  14. Cohorts 1, 2, and 3: Overall Survival (OS)

    OS is defined as the time from first study drug administration to the date of death due to any cause.

    Measured: Up to approximately 5 years

  15. Cohort 4: Time to next treatment

    Defined as the time from the start of treatment to the start of first subsequent therapy for WM.

    Measured: Up to approximately 5 years

  16. Number of participants reporting adverse events

    Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including laboratory abnormalities, physical examination results, and vital signs.

    Measured: Up to approximately 5 years

  17. All Cohorts: Change from Baseline in Health-Related Quality of Life (HRQoL): NFLymSI-18 Disease-related Symptoms-Physical and Treatment-Related Side Effects Subscales

    HRQoL based on participant-reported outcomes using National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Lymphoma Cancer Symptom Index - 18 Item (NFLymSI-18) Version 4. The questionnaire contains 18 items, each of which utilizes a Likert scale with 5 possible responses ranging from 0 'Not at all' to 4 'Very much' and is divided into a total score.

    Measured: Baseline and approximately months 7, 13, 19, and 25

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2023
  2. Study start23 Oct 2023
  3. Primary completion22 Sep 2026
  4. Study completionAug 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
114 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05952037
Sponsor's protocol ID
BGB-11417-203
Other IDs
U1111-1291-4524, CTR20232718, 2023-503235-18-00, 2023
Status last verified
Oct 2026
First submitted
11 Jul 2023
Last updated
20 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sonrotoclax and Zanubrutinib in people with Waldenstrom Macroglobulinemia and Waldenstrom's Macroglobulinemia Recurrent, run by BeOne Medicines at 72 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 72 sites in United States, China, United Kingdom, Australia, Italy and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cohort 1: Major Response Rate (MRR) (time frame: Up to approximately 4 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05952037.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.

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