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A Study to Investigate Safety and Effectiveness of Tacabrutideg (BGB-16673) in Combination With Other Agents in Participants With Relapsed or Refractory B-Cell Malignancies

StatusRecruiting
PhasePhase 1/2
Started2024-11-27
View on ClinicalTrials.gov ↗

Amendment history

2026-09-09
Study Status, Contacts/Locations v34
Study sites50→49
2026-08-20
Study Identification, Study Status, Study Description, Conditions, Arms and Interventions, Outcome Measures, Eligibility v33
InterventionsBGB-16673 (Drug), Glofitamab (Drug), Mosunetuzumab (Drug), Obinutuzumab (Drug), Sonrotoclax (Drug), Zanubrutinib (Drug)→Glofitamab (Drug), Mosunetuzumab (Drug), Obinutuzumab (Drug), Sonrotoclax (Drug), Tacabrutideg (Drug), Zanubrutinib (Drug)
Eligibility criteria+9 characters
[...] he last dose of sonrotoclax, 30 days after the last dose of BGB-16673tacabrutideg or zanubrutinib, 60 days after the last dose of glofitamab, [...] he last dose of sonrotoclax, 30 days after the last dose of BGB-16673tacabrutideg or zanubrutinib, 60 days after the last dose of glofitamab, [...] hypersensitivity to the active ingredient and excipients of BGB-16673tacabrutideg, sonrotoclax, zanubrutinib, mosunetuzumab, or glofitamab Su [...]
Secondary endpoints33 entries, revised
Substudy 1 Part 1a: Area under the plasma concentration-time curve (AUC) of BGB-16673tacabrutideg and sonrotoclax Substudy 1 Part 1a: Maximum observed concentration (Cmax) of BGB-16673tacabrutideg and sonrotoclax Substudy 1 Part 1a: Time to maximum concentration (Tmax) of BGB-16673tacabrutideg and sonrotoclax Substudy 1 Part 1a: Terminal half-life (t1/2) of BGB-16673tacabrutideg and sonrotoclax Substudy 1 Parts 1a and 1b: Trough concentration (Ctrough) of BGB-16673tacabrutideg and sonrotoclax Substudy 2 Part 1a: Area under the plasma concentration-time curve (AUC) of BGB-16673tacabrutideg and [...] [...]
Study description+3 characters
This new study will check how safe and helpful a potential anticancer drug called BGB-16673tacabrutideg is in participants with R/R B-cell malignancies when it is [...]
Study title+15 characters
A Study to Investigate Safety and Effectiveness of Tacabrutideg (BGB-16673) in Combination With Other Agents in Participants With Relapsed or Refractory B-Cell Malignancies
2026-08-18
Study Status v32
Re-verified, no change to tracked fields
2026-07-22
Study Status, Contacts/Locations v31
Study sites50 entries, revised
Narodowy Instytut Onkologii Im Marii Sklodowskiej Curie HematologyW UnitWarszawie
2026-07-09
Study Status, Contacts/Locations v30
Study sitesdetails revised at 1 of 50 sites
Show 29 earlier versions
2026-06-01
Study Status, Contacts/Locations v29
Study sites50 entries, revised
Universitatsklinikum Schleswig Holstein, Campus Kiel
2026-05-08
Study Status, Contacts/Locations v28
Study sites50 entries, revised
University of Southern CalifornianorrisCalifornia Norris Comprehensive
2026-05-06
Study Status, Eligibility v27
Eligibility criteria+308 characters
[...] ain from egg donation for the duration of the study and for ≥ 7 days after the last dose of sonrotoclax, 30 days after the last dose of BGB-16673 or zanubrutinib, 60 [...] last dose of glofitamab, or 90 days after the last dose of sonrotoclax or mosunetuzumab. A negative urine or serum pregnancy test resu [...] in from sperm donation for the duration of the study and for ≥ 7 days after the last dose of sonrotoclax, 30 days after the last dose of BGB-16673 or zanubrutinib, 6 [...] last dose of glofitamab, or 90 days after the last dose of sonrotoclax or mosunetuzumab Substudies 1, 3, and 4 Inclusion Criterion: Ad [...] [...]
2026-04-14
Study Status, Contacts/Locations v26
Study sites49→50
2026-03-17
Study Status, Contacts/Locations v25
Study sites48→49
2026-03-04
Study Status, Contacts/Locations v24
Study sites45→48
2026-02-20
Study Status, Contacts/Locations v23
Study sites41→45
2026-02-03
Study Status, Contacts/Locations v22
Study sites40→41
2026-01-21
Study Status, Contacts/Locations v21
Study sites39→40
2026-01-09
Study Status, Study Description, Contacts/Locations v20
Study sites37→39
Study description+210 characters
[...] , mosunetuzumab in substudy 3, and glofitamab in substudy 4. 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.
2025-12-22
Study Status, Contacts/Locations v19
Study sites32→37
2025-12-15
Study Status, Contacts/Locations v18
Study sites31→32
2025-11-19
Study Status, Contacts/Locations v17
Study sites30→31
2025-11-07
Study Status, Contacts/Locations v16
Study sites29→30
2025-10-23
Study Identification, Study Status, Sponsor/Collaborators, Contacts/Locations, IPDSharing v15
Study sites50→29
Lead sponsorBeiGene→BeOne Medicines
2025-09-19
Study Status, Contacts/Locations v14
Study sites50 entries, revised
Narodowy Instytut Onkologii Im Marii SkodowskiejSklodowskiej Curie Hematology Unit
2025-08-19
Study Status, Contacts/Locations v13
Study sitesdetails revised at 7 of 50 sites
2025-08-05
Study Status, Contacts/Locations v12
Study sitesdetails revised at 1 of 50 sites
2025-07-22
Study Status, Contacts/Locations v11
Study sitesdetails revised at 5 of 50 sites
2025-07-10
Study Status, Contacts/Locations v10
Study sites49→50
2025-06-04
Study Status, Contacts/Locations v9
Study sites45→49
2025-05-07
Study Status, Contacts/Locations v8
Study sites46→45
2025-04-29
Study Status, Contacts/Locations v7
Study sites46 entries, revised
Centro RicercheCentroricerche Cliniche Di Verona Srl
2025-04-10
Study Status, Contacts/Locations v6
Study sites46 entries, revised
Universitaetsklinikum Ulm, Innere Medizin Iii Szpital Kliniczny Mswia Z WarminskoWarmisko Mazurskim Centrum Onkologii
2025-03-20
Study Status, Contacts/Locations v5
Study sites46 entries, revised
Szpital Kliniczny Mswia Z WarmiskoWarminsko Mazurskim Centrum Onkologii
2025-03-04
Study Identification, Study Status, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations, IPDSharing v4
Enrollment target170→80
Study arms4→8
InterventionsBGB-16673 (Drug), Zanubrutinib (Drug), sonrotoclax (Drug)→BGB-16673 (Drug), Glofitamab (Drug), Mosunetuzumab (Drug), Obinutuzumab (Drug), Sonrotoclax (Drug), Zanubrutinib (Drug)
Eligibility criteria+678 characters
[...] r 30 days after the last dose of BGB-16673 or zanubrutinib, 60 days after the last dose of glofitamab, or 90 days after the last dose of sonrotoclax or mosunetuzumab. A negative urine or serum pregnancy test result must be pr [...] r 30 days after the last dose of BGB-16673 or zanubrutinib, 60 days after the last dose of glofitamab, or 90 days after the last dose of sonrotoclax or mosunetuzumab Substudies 1, 3, and 4 Inclusion Criterion: Adequate renal function as indicated by estimated glomerular filtration rate (eGFR) of ≥ 50 mL/min Substudy 2 Inclusion Criteria: Bruton tyrosine kinase (BTK) inhibi [...] [...]
Secondary endpoints17 to 33 entries
Substudy 1 PartParts 1a and 1b: Overall Response Rate (ORR) forin BGBparticipants with B-16673cell and sonrotoclaxmalignancies Substudy 1 PartParts 1a and 1b: Duration of Response (DOR) for BGB-16673 and sonrotoclax Substudy 1 PartParts 1a and 1b: Time to Response (TTR) for BGB-16673 and sonrotoclax Substudy 1 PartParts 1a and 1b: Trough concentration (Ctrough) of BGB-16673 and sonrotoclax Substudy 2 PartParts 1a and 1b: ORR forin BGBparticipants with B-16673cell and zanubrutinibmalignancies Substudy 2 PartParts 1a and 1b: DOR for BGB-16673 and zanubrutinib Substudy 2 PartParts 1a and 1b: TTR [...] [...]
Primary endpoints4 to 8 entries
Substudy 3 Part 1a: Number of participants with dose-limiting toxicities (DLTs), treatment-emergent adverse events, treatment-related adverse events, and serious adverse events Substudy 3 Part 1b: Number of participants with treatment-emergent adverse events, treatment-related adverse events, and se [...]
Study description+50 characters
[...] mbination with other medicines - sonrotoclax in substudy 1, and with zanubrutinib in substudy 2, mosunetuzumab in substudy 3, and glofitamab in substudy 4.
Study sitesdetails revised at 2 of 46 sites
2025-01-28
Study Status, Contacts/Locations v3
Study sites46 entries, revised
Szpital Kliniczny Mswia Z WarminskoWarmisko Mazurskim Centrum Onkologii
2025-01-09
Study Status, Contacts/Locations v2
Study sites43→46
2024-12-13
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-12-02→confirmed 2024-11-27
Study sites0→43
2024-10-08
Original filing
The purpose of this study is to measure the safety, preliminary antitumor activity, pharmacokinetics, and pharmacodynamics with tacabrutideg in combination with other agents in participants with relapsed or refractory (R/R) B-cell malignancies. This study is structured as a master protocol with separate substudies. This study currently includes four substudies, and more substudies may be added as other combination agents are identified.
Trial Details
NCT Number NCT06634589
Lead Sponsor BeOne Medicines
Conditions B-cell Malignancy, Relapsed Cancer, Refractory Cancer, B-cell Lymphoma
Enrollment 80 participants
Start Date 2024-11-27
Primary Completion 2028-12-02 (estimated)
Study Completion 2029-12-02 (estimated)
Updated on ClinicalTrials.gov 2026-09-11