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Clinical Trials in Poland / NCT06634589
Recruiting Phase 1/2

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

NCT06634589 · tracked via the Priya Life Science Poland tracker
Phase
Phase 1/2
Started
2024-11-27
Last updated
2026-09-11

Condition(s) studied

B-cell MalignancyRelapsed CancerRefractory CancerB-cell Lymphoma

Investigational drug(s) / intervention(s)

Tacabrutideg →Sonrotoclax →Zanubrutinib →Mosunetuzumab →Glofitamab →Obinutuzumab →

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Key Inclusion Criteria: * Must sign the informed consent form (ICF) and be capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the ICF * Confirmed diagnosis of a R/R B-cell malignancy * Protocol-defined measurable disease * Stable Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2 * Adequate organ function * Female participants of childbearing potential must be willing to use a highly effective method of birth control and refrain 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 tacabrutideg or zanubrutinib, 60 days after the last dose of glofitamab, or 90 days after the last dose of mosunetuzumab. A negative urine or serum pregnancy test result must be provided 10-14 days before the first dose of study treatment * Nonsterile male participants must be willing to use a highly effective method of birth control and refrain 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 tacabrutideg or zanubrutinib, 60 days after the last dose of glofitamab, or 90 days after the last dose of 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) inhibitor-naive, or previously received treatment with a covalent BTK inhibitor and discontinued for reasons other than clinical progression * Adequate renal function as indicated by eGFR of ≥ 30 mL/min Key Exclusion Criteria: * Treatment-naive B-cell malignancies * Unable to comply with the requirements of the protocol * Active leptomeningeal disease or uncontrolled, untreated brain metastasis * Any malignancy ≤ 2 years before first dose of study treatment except for the specific cancer under investigation in this study or any locally recurring cancer that has been treated curatively * Autologous stem cell transplant ≤ 3 months prior to screening or chimeric antigen T-cell therapy ≤ 3 months prior to screening * Prior invasive fungal infection, except if participant agrees to receive secondary antifungal prophylaxis during the entire treatment period * Substudies 1 and 2: Prior allogeneic stem cell transplant with active graft-versus-host disease (GVHD), or requiring immunosuppressive drugs for treatment of GVHD, or who have taken calcineurin inhibitors within 4 weeks prior to consent * Participants who have a history of severe allergic reactions or hypersensitivity to the active ingredient and excipients of tacabrutideg, sonrotoclax, zanubrutinib, mosunetuzumab, or glofitamab * Substudy 1 Exclusion Criterion: * Prior treatment with a B-cell lymphoma-2 (Bcl-2) inhibitor (with exception for participants who relapsed ≥ 24 months after completion of a full course of a prior Bcl-2 inhibitor containing regimen) * Substudy 2 Exclusion Criterion: * Participants who discontinued prior zanubrutinib treatment due to intolerance * Substudies 3 and 4 Exclusion Criteria: * Prior exposure to a CD20 x CD3 T-cell engager antibody treatment * All participants with a prior allogeneic stem cell transplant * Participants with known contraindications to azole antifungal agents, including hypersensitivity reactions Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcome measure(s)

Trial sites (49)

FacilityCityRegionStatus
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 Poland

Other trials for the same condition

Official registry record

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 Poland