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Study of Sonrotoclax (BGB-11417) Monotherapy in Participants With Relapsed or Refractory Mantle Cell Lymphoma

StatusActive, Not Recruiting
PhasePhase 1/2
Started2022-09-05
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint reworded 4 of 4 changed
See other at-risk trials from BeOne Medicines

Amendment history

2026-09-23
Primary endpoint(s) modified4 entries, revised
WasPart 1: Number Of Participants Experiencing Dose-limiting Toxicities (DLTs), Part 1: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and adverse events leading to discontinuation., Part 1: Number of participants experiencing tumor lysis syndrome (TLS) relevant events, Part 2: Overall Response Rate (ORR) as assessed by the Independent Review Committee (IRC)
NowPart 1: Number of Participants Experiencing Dose-limiting Toxicities (DLTs), Part 1: Number of Participants Experiencing Tumor Lysis Syndrome (TLS) Adverse Events, Part 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events Leading to Treatment Discontinuation, Part 2: Overall Response Rate (ORR) as Assessed by the Independent Review Committee (IRC)
Sponsor changed: BeiGene → BeOne Medicines+8 characters
WasBeiGene
NowBeOne Medicines
Trial arms changed: 1 → 4
Trial sites reduced: 104 → 65 locations
Results posted: 2026-09-22
Interventions modified
2026-07-17
Study Identification, Study Status, Sponsor/Collaborators, Study Description, Study Design, Arms and Interventions, Outcome Measures, Contacts/Locations, IPDSharing, References, Document Section, Participant Flow v25
Study sites104→65
Study arms1→4
Lead sponsorBeiGene→BeOne Medicines
InterventionsBGB-11417 (Drug)→Sonrotoclax (Drug)
Secondary endpoints18 to 28 entries
Part 1: Single Dose Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Measurable Concentration (AUCAUClast) of Sonrotoclax After a Single Dose Part 1: Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Measurable Concentration (AUClast) of Sonrotoclax at Steady-State Part 1: Time to Maximum Observed Concentration of Sonrotoclax (Tmax) After a Single Dose Part 1: Time to Maximum Observed Concentration of Sonrotoclax (Tmax) at Steady State Part 1: Maximum Observed Plasma Concentration (Cmax) of Sonrotoclax After a Single Dose Part 1: Single Dose Time to r [...] [...]
Primary endpoints4 entries, revised
Part 1: Number Ofof Participants Experiencing Dose-limiting Toxicities (DLTs) Part 1: Number of Participants ReportingExperiencing OneTumor orLysis MoreSyndrome (TLS) Adverse Events Part 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and adverseAdverse eventsEvents leadingLeading to discontinuation. PartTreatment 1: Number of participants experiencing tumor lysis syndrome (TLS) relevant eventsDiscontinuation Part 2: Overall Response Rate (ORR) as assessedAssessed by the Independent Review Committee (IRC)
Publications1 to 4 entries
Wang M, Schuster SJ, Phillips T, Lossos IS, Goy A, Rule S, Hamadani M, Ghosh N, Reeder CB, Barnett E, Bravo MC, Martin P. Observational study of lenalidomide in patients with mantle cell lymphoma who relapsed/progressed after or were refractory/intolerant to ibrutinib (MCL-004). J Hematol Oncol. 201 [...]
Study title+14 characters
Study of Sonrotoclax (BGB-11417) Monotherapy in Participants With Relapsed or Refractory Mantle Cell Lymphoma
2025-09-05
Study Status, Study Design v24
Completion date2027-08→2027-01-31
Enrollment target126→125
2025-03-31
Study Status v23
Primary completion date2025-04→2025-07-18
2024-12-16
Study Status, Contacts/Locations v22
Study sites58→104
Show 21 earlier versions
2024-10-24
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v21
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2024-11→2025-04
Study sites17→58
2024-08-16
Study Identification, Study Status, Study Design, Contacts/Locations v20
Enrollment target122→126
Study sites74→17
2024-06-05
Study Status, Contacts/Locations v19
Study sites105→74
2024-05-29
Study Status, Contacts/Locations v18
Study sites105 entries, revised
Samodzielny PublicznyUniwersytecki Szpital Kliniczny Nr W Lublinie
2024-04-24
Study Status, Contacts/Locations v17
Study sites96→105
2024-02-05
Study Status, Contacts/Locations v16
Study sites96 entries, revised
Rabin Medical CentreCenter
2024-01-17
Study Status, Contacts/Locations v15
Study sites89→96
2024-01-03
Study Status, Contacts/Locations v14
Study sites89 entries, revised
Medstar Georgetown University Hospital Fort Wayne Medical Center JiangsuOncology Provinceand HospitalHematology
2023-12-19
Study Identification, Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v13
PhasePhase 2→Phase 1/2
Primary completion date2024-03→2024-11
Enrollment target98→122
Study sites85→89
Eligibility criteria+24 characters
[...] ic treatments for MCL (at least one line of anti-cluster of differentiatedifferentiation 20 (anti-CD20) based immune or chemoimmunotherapy and at least one linekind of treatmentcovalent withor non-covalent adequate Bruton Tyrosine Kinase Inhibitor (BTKiBTK) as mono- or combination therapyinhibitor). relapsedRelapsed/refractory disease Presence of measurable disease Availabil [...] alized Gleason score 6 prostate cancer. Prior exposure to a BclBCL-2 inhibitor (eg, venetoclax/ABT-199). Prior autologous stem cell transplant within the last 3 months; or prior autologous chimeric antigen receptor T-cell t [...]
Secondary endpoints18 entries, revised
Part 1: Single Dose Area Under the Plasma Concentration Time Curve (AUC) Part 1: Single Dose Maximum Observed Plasma Concentration (Cmax) Part 1: Single Dose Time to reach Cmax (Tmax) Part 1: Overall Response Rate (ORR) as assessed by investigator Duration of Response (DOR) as assessed by investigator (Part 1 and 2) and IRC (Part 2) Progression Free Survival (PFS) as assessed by investigator (Part 1 and 2) and IRC (Part 2) Time to Response (TTR) as assessed by investigator (Part 1 and 2) and IRC (Part 2) Part 2: Number of Participants With Clinically Significant Physical Examination Findings P [...] [...]
2023-11-08
Study Identification, Study Status, Contacts/Locations v12
Study sites78→85
2023-10-26
Study Identification, Study Status, Contacts/Locations v11
Study sites71→78
2023-09-20
Study Status, Contacts/Locations v10
Study sites59→71
2023-08-23
Study Status, Contacts/Locations v9
Study sites47→59
2023-07-17
Study Status, Contacts/Locations v8
Study sites24→47
2023-04-05
Study Status, Contacts/Locations v7
Study sitescontacts updated at 1 of 24 sites
2023-03-16
Study Status, Contacts/Locations v6
Study sitescontacts updated at 1 of 24 sites
2023-03-01
Study Status, Contacts/Locations v5
Study sites24 entries, revised
BannerUniversity of Texas, MD Anderson Cancer Center
2023-02-23
Study Status, Contacts/Locations v4
Study sites22→24
2023-01-23
Study Status, Contacts/Locations v3
Study sites7→22
2022-10-17
Not Yet Recruiting→Recruiting Study Status, Outcome Measures, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2022-08→confirmed 2022-09-05
Study sites0→7
Secondary endpoints18 entries, revised
Part 1: Maximum Observed Plasma Concentration (Cmax) Part 1: Overall Response Rate (ORR) as assessed by investigator Duration of Response (DOR) as assessed by investigator (Part 1 and 2) and IRC (Part 2) Progression Free Survival (PFS) as assessed by investigator (Part 1 and 2) and IRC (Part 2) Time to Response (TTR) as assessed by investigator (Part 1 and 2) and IRC (Part 2) Part 2: Number of Participants ExperiencingReporting One or More Treatment-emergent Adverse Events (AEsTEAEs), Serious Adverse Events (SAEs), and adverse events leading to discontinuation.
Primary endpoints4 entries, revised
Part 1: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and, Serious Adverse Events (SAEs), and adverse events leading to discontinuation.
2022-07-25
Study Identification, Study Status v1
Study title-10 characters
A Phase 2 Study of BGB-11417 Monotherapy in Participants With Relapsed or Refractory Mantle Cell Lymphoma
2022-07-21
Original filing
The study consists of two parts. Part 1 determines the safety and tolerability of sonrotoclax monotherapy, the maximum tolerated dose, and the recommended Phase 2 dose of sonrotoclax monotherapy for relapsed or refractory mantle cell lymphoma. Part 2 evaluates efficacy of sonrotoclax monotherapy at the recommended Phase 2 dose with recommended ramp-up schedule from Part 1.
Trial Details
NCT Number NCT05471843
Lead Sponsor BeOne Medicines
Conditions Mantle Cell Lymphoma, Refractory Mantle Cell Lymphoma (MCL), Relapsed Mantle Cell Lymphoma
Enrollment 125 participants
Start Date 2022-09-05
Primary Completion 2025-07-18 (estimated)
Study Completion 2027-01-31 (estimated)
Updated on ClinicalTrials.gov 2026-09-22