NCT06634589 · BeiGene
A Study to Investigate Safety and Effectiveness of BGB-16673 in Combination With Other Agents in Participants With Relapsed or Refractory B-Cell Malignancies
What this study is about
The purpose of this study is to measure the safety, preliminary antitumor activity, how the drug moves through the body, and how the drug affects the body with BGB-16673 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.
View original scientific description
The purpose of this study is to measure the safety, preliminary antitumor activity, pharmacokinetics, and pharmacodynamics with BGB-16673 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
DRUG
Tacabrutideg
Administered orally
DRUG
Sonrotoclax
Administered orally
DRUG
Zanubrutinib
Administered orally
DRUG
Mosunetuzumab
Administered subcutaneously
DRUG
Glofitamab
Administered intravenously
DRUG
Obinutuzumab
Administered intravenously
Primary outcome measures
Substudy 1 Part 1a: Number of participants with dose-limiting toxicities (DLTs), treatment-emergent adverse events, treatment-related adverse events, and serious adverse events
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Phoenix, Arizona
- Los Angeles, California
- Jacksonville, Florida
- Tampa, Florida
- Westwood, Kansas
- Rochester, Minnesota
- St Louis, Missouri
- New York, New York
- Rochester, New York
- Philadelphia, Pennsylvania
- Houston, Texas
- Salt Lake City, Utah
And 2 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 11, 2026 · Source of record for eligibility and locations