RECRUITING Phase 1 / Phase 2 ClinicalTrials.gov

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

Sponsor: BeOne Medicines • ClinicalTrials.gov ID: NCT06634589

Registry updated: 2026-09-11

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Description

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.

Interventions

Tacabrutideg (Drug)
Administered orally
Sonrotoclax (Drug)
Administered orally
Zanubrutinib (Drug)
Administered orally
Mosunetuzumab (Drug)
Administered subcutaneously
Glofitamab (Drug)
Administered intravenously
Obinutuzumab (Drug)
Administered intravenously

Eligibility criteria

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.

Conditions

B-cell Malignancy Relapsed Cancer Refractory Cancer B-cell Lymphoma

Locations

Mayo Clinic Phoenix — Phoenix, Arizona, United States
University of Southern California Norris Comprehensive — Los Angeles, California, United States
Mayo Clinic Jacksonville — Jacksonville, Florida, United States
Moffitt Cancer Center — Tampa, Florida, United States
The University of Kansas Cancer Center — Westwood, Kansas, United States
Mayo Clinic Rochester — Rochester, Minnesota, United States
Washington University School of Medicine — St Louis, Missouri, United States
Icahn School of Medicine At Mount Sinai — New York, New York, United States
Columbia University Medical Center — New York, New York, United States
Weill Cornell Medical College Newyork Presbyterian Hospital — New York, New York, United States
Memorial Sloan Kettering Cancer Center Mskcc — New York, New York, United States
University of Rochester — Rochester, New York, United States
Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
The University of Texas Md Anderson Cancer Center — Houston, Texas, United States
Huntsman Cancer Institute — Salt Lake City, Utah, United States
University of Wisconsin — Madison, Wisconsin, United States
Medical College of Wisconsin — Milwaukee, Wisconsin, United States
St George Hospital — Kogarah, New South Wales, Australia
Mater Cancer Care Centre — South Brisbane, Queensland, Australia
Monash Health — Clayton, Victoria, Australia
Peter Maccallum Cancer Centre — Melbourne, Victoria, Australia
The Alfred Hospital — Melbourne, Victoria, Australia
Linear Clinical Research — Nedlands, Western Australia, Australia
Hospital Sirio Libanes Brasilia — Brasília, Brazil
Ensino E Terapia de Inovacao Clinica Amo Etica — Salvador, Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto — São José do Rio Preto, Brazil
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein — São Paulo, Brazil
Fujian Medical University Union Hospital — Fuzhou, Fujian, China
Sun Yat Sen University Cancer Center — Guangzhou, Guangdong, China
The First Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China
The First Affiliated Hospital, Zhejiang University School of Medicinechengzhan — Hangzhou, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University — Wenzhou, Zhejiang, China
Universitatsklinikum Carl Gustav Carus An Der Technischen Universitat Dresden — Dresden, Germany
Universitatsklinikum Jena Klinik Fur Innere Medizin Ii — Jena, Germany
Universitatsklinikum Schleswig Holstein Campus Kiel — Kiel, Germany
Medizinische Universitaetsklinik — Tübingen, Germany
Universitaetsklinikum Ulm — Ulm, Germany
Azienda Ospedaliera Universitaria Policlinico Santorsola Malpighi — Bologna, Italy
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda — Milan, Italy
Istituto Nazionale Tumori Fondazione G Pascale — Naples, Italy
Istituto Clinico Humanitas — Rozzano, Italy
Centroricerche Cliniche Di Verona Srl — Verona, Italy
North Shore Hospital — Auckland, New Zealand
Auckland City Hospital — Auckland, New Zealand
Uniwersyteckie Centrum Kliniczne — Gdansk, Poland
Uniwersytecki Szpital Kliniczny Nr 1 W Lublinie — Lublin, Poland
Szpital Kliniczny Mswia Z Warmisko Mazurskim Centrum Onkologii — Olsztyn, Poland
Szpital Wojewodzki W Opolu Sp Z Oo Oddzia Hematologii I Onkologii Hematologicznej — Opole, Poland
Narodowy Instytut Onkologii Im Marii Sklodowskiej Curie W Warszawie — Warsaw, Poland

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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