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

StatusActive, Not Recruiting
PhasePhase 2
Started2023-10-23
View on ClinicalTrials.gov ↗
Record status
This record was last updated January 2, 2026 (before its estimated September 22, 2026 completion). Its status may not reflect the trial's current state.

Amendment history

2025-12-30
Study Status, Study Description v31
Primary completion date2026-12→2026-09-22
Start date2023-09-28→2023-10-23
Study description+216 characters
[...] 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.
2025-11-20
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v30
Trial statusRecruiting→Active, Not Recruiting
Enrollment targetestimated 105→confirmed 114
Study sitesdetails revised at 72 of 72 sites
2025-11-10
Study Status, Contacts/Locations v29
Study sitesdetails revised at 2 of 72 sites
2025-10-22
Study Identification, Study Status, Sponsor/Collaborators, Contacts/Locations, IPDSharing v28
Lead sponsorBeiGene→BeOne Medicines
Study sitesdetails revised at 9 of 72 sites
2025-09-11
Study Status, Contacts/Locations v27
Study sitesdetails revised at 10 of 72 sites
Show 26 earlier versions
2025-08-28
Study Status, Contacts/Locations v26
Study sitesdetails revised at 8 of 72 sites
2025-07-03
Study Status, Arms and Interventions v25
Re-verified, no change to tracked fields
2025-06-25
Study Status v24
Primary completion date2027-11→2026-12
Completion date2028-09→2028-08
2025-04-10
Study Status, Contacts/Locations v23
Study sitesdetails revised at 22 of 72 sites
2025-04-07
Study Identification, Study Status, Study Description, Conditions, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations, IPDSharing v22
InterventionsBGB-11417 (Drug), Zanubrutinib (Drug)→Sonrotoclax (Drug), Zanubrutinib (Drug)
Eligibility criteria+1 characters
[...] emia (IWWM). For Cohorts 1-3, refractory or relapsed disease to the most recent therapy at study entry unless participants had intolerance to the m [...] hort 4, patients must not have received prior therapy for WM (except for plasmapheresis). Adequate organ function. Exclusion Criteria: Central nervo [...]
Secondary endpoints17 entries, revised
Cohort 4: Time to next treatment in cohort 4 All Cohorts: Change from Baseline in Health-Related Quality of Life (HRQoL): NFLymSI-18 Disease-related Symptoms-Physical and Treatment-Related Side Effects Subscales
Study description-129 characters
This study will test whether sonrotoclax (BGB-11417 (sonrotoclax) can be used to improve outcomes in participants with Walde [...] in goals of the study are to determine how many participants may no longer have evidence of cancer or have some improvement [...] time to participate in this study is approximately 5 years. Treatments will continue until participants experience worsening disease status, too many side effects, or withdraw consent.
Study sites72 entries, revised
Shengjing Hospital of China Medical UniversityUniversityshenbei Branch
Study title+60 characters
A Study to Evaluate theInvestigate Efficacy and Safety of BCL2 Inhibitor Sonrotoclax as Monotherapy and in ParticipantsCombination With Zanubrutinib in Adults With Waldenström's Macroglobulinemia
2025-01-28
Study Status, Contacts/Locations v21
Study sites72 entries, revised
Shengjing Hospital Affiliated of China Medical University
2024-12-04
Study Status, Contacts/Locations v20
Study sites15→72
2024-11-07
Study Status, Contacts/Locations v19
Study sites14→15
2024-10-25
Study Status, Contacts/Locations v18
Study sites67→14
2024-10-17
Study Status, Contacts/Locations v17
Study sites61→67
2024-09-27
Study Status, Contacts/Locations v16
Study sites57→61
2024-08-27
Study Status, Contacts/Locations v15
Study sites49→57
2024-08-19
Study Status, Contacts/Locations v14
Study sites43→49
2024-07-30
Study Status, Contacts/Locations v13
Study sites39→43
2024-07-16
Study Status, Contacts/Locations v12
Study sites38→39
2024-07-08
Study Status, Contacts/Locations v11
Study sites35→38
2024-06-21
Study Identification, Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v10
Enrollment target85→105
Study sites31→35
Study arms3→4
InterventionsBGB-11417 (Drug)→BGB-11417 (Drug), Zanubrutinib (Drug)
Eligibility criteria+85 characters
[...] ational Workshop on Waldenström's Macroglobulinemia (IWWM). RefractoryFor Cohorts 1-3, refractory or relapsed disease to the most recent therapy at study ent [...] sease progression beyond 6 months after completing therapy. For Cohort 4, patients must not have received prior therapy for WM. Adequate organ function. Exclusion Criteria: Central nervous [...]
Secondary endpoints9 to 17 entries
Cohorts 2 and 3: MRR inas assessed by the IRC All Cohorts: MRR as assessed by the Investigator Cohorts 1, 2, and 3: Duration of Major Response (DoMR) as assessed by the IRC All Cohorts: DoMR as assessed by the Investigator Cohorts 1, 2, and 3: Complete Response (CR) + Very Good Partial Response (VGPR) as assessed by the IRC All Cohorts: CR + VGPR as assessed by the Investigator Cohorts 1, 2, and 3: Overall Response Rate (ORR) as assessed by the IRC All cohorts: ORR as [...] Duration of Response (DOR) as assessed by the IRC CRAll +Cohorts: VGPRDOR rateas assessed by the investigator OverallCohorts Re [...] [...]
Primary endpoints1 entry, revised
Cohort 1: Major Response Rate (MRR) in Cohort 1
Study description+147 characters
This study will test whether BGB-11417 (sonrotoclax) 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 part [...] cancers, including WM. This study will enroll approximately 85105 patientsparticipants. All patientsparticipants will receive BGB-11417sonrotoclax orally as a tablet. The study will take place at multiple c [...]
Study title+2 characters
Study to Evaluate the Efficacy and Safety of BGB-11417Sonrotoclax in Participants With Waldenström's Macroglobulinemia
2024-04-23
Study Status, Contacts/Locations v9
Study sites22→31
2024-02-28
Study Status, Contacts/Locations v8
Study sites18→22
2024-01-31
Study Status, Contacts/Locations v7
Study sites14→18
2024-01-11
Study Identification, Study Status, Contacts/Locations v6
Study sites8→14
2024-01-04
Study Status, Contacts/Locations v5
Study sites6→8
2023-10-25
Study Status, Contacts/Locations v4
Study sites5→6
2023-10-18
Study Status, Contacts/Locations v3
Study sites1→5
2023-10-03
Study Status v2
Start dateestimated 2023-10→confirmed 2023-09-28
2023-09-18
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start date2023-08→2023-10
Study sites0→1
2023-07-18
Original filing
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 Details
NCT Number NCT05952037
Lead Sponsor BeOne Medicines
Conditions Waldenstrom Macroglobulinemia, Waldenstrom's Macroglobulinemia Recurrent, Waldenstrom's Macroglobulinemia Refractory
Enrollment 114 participants
Start Date 2023-10-23
Primary Completion 2026-09-22 (estimated)
Study Completion 2028-08 (estimated)
Updated on ClinicalTrials.gov 2026-01-02