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
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)
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
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.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.