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
Condition(s) studied
Investigational drug(s) / intervention(s)
Tacabrutideg: Administered orally
Sonrotoclax: Administered orally
Zanubrutinib: Administered orally
Mosunetuzumab: Administered subcutaneously
Glofitamab: Administered intravenously
Obinutuzumab: Administered intravenously
Study summary
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.
Eligibility
Primary outcome measure(s)
- Substudy 1 Part 1a: Number of participants with dose-limiting toxicities (DLTs), treatment-emergent adverse events, treatment-related adverse events, and serious adverse events — From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
- Substudy 1 Part 1b: Number of participants with treatment-emergent adverse events, treatment-related adverse events, and serious adverse events — From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
- Substudy 2 Part 1a: Number of participants with dose-limiting toxicities (DLTs), treatment-emergent adverse events, treatment-related adverse events, and serious adverse events — From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
- Substudy 2 Part 1b: Number of participants with treatment-emergent adverse events, treatment-related adverse events, and serious adverse events — From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
- Substudy 3 Part 1a: Number of participants with dose-limiting toxicities (DLTs), treatment-emergent adverse events, treatment-related adverse events, and serious adverse events — From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
- Substudy 3 Part 1b: Number of participants with treatment-emergent adverse events, treatment-related adverse events, and serious adverse events — From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years]
- Substudy 4 Part 1a: Number of participants with dose-limiting toxicities (DLTs), treatment-emergent adverse events, treatment-related adverse events, and serious adverse events — From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
- Substudy 4 Part 1b: Number of participants with treatment-emergent adverse events, treatment-related adverse events, and serious adverse events — From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
Trial sites (49)
| Facility | City | Region | Status |
|---|---|---|---|
| Mayo Clinic Phoenix | Phoenix | Arizona | Recruiting |
| University of Southern California Norris Comprehensive | Los Angeles | California | Recruiting |
| Mayo Clinic Jacksonville | Jacksonville | Florida | Recruiting |
| Moffitt Cancer Center | Tampa | Florida | Recruiting |
| The University of Kansas Cancer Center | Westwood | Kansas | Recruiting |
| Mayo Clinic Rochester | Rochester | Minnesota | Recruiting |
| Washington University School of Medicine | St Louis | Missouri | Recruiting |
| Icahn School of Medicine At Mount Sinai | New York | New York | Recruiting |
| Columbia University Medical Center | New York | New York | Recruiting |
| Weill Cornell Medical College Newyork Presbyterian Hospital | New York | New York | Recruiting |
| Memorial Sloan Kettering Cancer Center Mskcc | New York | New York | Recruiting |
| University of Rochester | Rochester | New York | Recruiting |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | Recruiting |
| The University of Texas Md Anderson Cancer Center | Houston | Texas | Recruiting |
| Huntsman Cancer Institute | Salt Lake City | Utah | Recruiting |
| University of Wisconsin | Madison | Wisconsin | Recruiting |
| Medical College of Wisconsin | Milwaukee | Wisconsin | Recruiting |
| St George Hospital | Kogarah | New South Wales | Recruiting |
| Mater Cancer Care Centre | South Brisbane | Queensland | Recruiting |
| Monash Health | Clayton | Victoria | Recruiting |
| Peter Maccallum Cancer Centre | Melbourne | Victoria | Recruiting |
| The Alfred Hospital | Melbourne | Victoria | Recruiting |
| Linear Clinical Research | Nedlands | Western Australia | Recruiting |
| Hospital Sirio Libanes Brasilia | Brasília | Brazil | Recruiting |
| Ensino E Terapia de Inovacao Clinica Amo Etica | Salvador | Brazil | Recruiting |
| Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto | São José do Rio Preto | Brazil | Recruiting |
| Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein | São Paulo | Brazil | Recruiting |
| Fujian Medical University Union Hospital | Fuzhou | Fujian | Recruiting |
| Sun Yat Sen University Cancer Center | Guangzhou | Guangdong | Recruiting |
| The First Affiliated Hospital of Soochow University | Suzhou | Jiangsu | Recruiting |
| The First Affiliated Hospital, Zhejiang University School of Medicinechengzhan | Hangzhou | Zhejiang | Recruiting |
| The First Affiliated Hospital of Wenzhou Medical University | Wenzhou | Zhejiang | Recruiting |
| Universitatsklinikum Carl Gustav Carus An Der Technischen Universitat Dresden | Dresden | Germany | Recruiting |
| Universitatsklinikum Jena Klinik Fur Innere Medizin Ii | Jena | Germany | Recruiting |
| Universitatsklinikum Schleswig Holstein Campus Kiel | Kiel | Germany | Recruiting |
| Medizinische Universitaetsklinik | Tübingen | Germany | Recruiting |
| Universitaetsklinikum Ulm | Ulm | Germany | Recruiting |
| Azienda Ospedaliera Universitaria Policlinico Santorsola Malpighi | Bologna | Italy | Recruiting |
| Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda | Milan | Italy | Recruiting |
| Istituto Nazionale Tumori Fondazione G Pascale | Naples | Italy | Recruiting |
+ 9 more sites — see the full list on the official registry below.
On this site
📄 Brukinsa (zanubrutinib) drug profile →More BeOne Medicines trials in Italy
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06634589 on ClinicalTrials.gov ↗ ← All trials in Italy