Study of BGB-16673 with Other Treatments for B-Cell Malignancies
This study is looking at the safety and effectiveness of a drug called BGB-16673 when given with other medicines (Sonrotoclax, Zanubrutinib, Mosunetuzumab, or Glofitamab) for people with B-cell malignancies (a type of blood cancer) that have come back (relapsed) or are not responding to treatment (refractory). The study aims to see how well these combinations work and what side effects they might have. You could be eligible if you are 18 or older, have a confirmed diagnosis of relapsed or refractory B-cell malignancy, and meet other health requirements. The study will measure side effects and how many participants experience them for up to two years after starting treatment. The study plans to enroll 80 participants, but its current status is unclear.
- Study design
- This is an interventional study structured with different substudies, each testing BGB-16673 with a different combination drug. It plans to enroll 80 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for safety and side effects from the first dose of study drug(s) to 30 days after the last dose, for up to approximately 2 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06634589
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
Recruiting
PHASE1Ages 18+InterventionalTreatmentBeOne Medicines
~80 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:TacabrutidegSonrotoclaxZanubrutinibMosunetuzumabGlofitamabObinutuzumab
At a glance
Recruiting sites
50 of 50 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Substudy 1 Part 1a: Number of participants with dose-limiting toxicities (DLTs), treatment-emergent adverse events, treatment-related adverse events, and serious adverse events
Measured over From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
+7 more outcomes measured
Conditions
Where it's being run
50 sites across 25 statesNew York5
Germany5
Italy5
Poland5
Brazil4
Victoria3
Florida2
Wisconsin2
Study leadership
- Study Director · STUDY_DIRECTOR · BeOne Medicines
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
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
Exclusion
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
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
What this trial measures
- Substudy 1 Part 1a: Number of participants with dose-limiting toxicities (DLTs), treatment-emergent adverse events, treatment-related adverse events, and serious adverse eventsFrom 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 eventsFrom 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 eventsFrom 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 eventsFrom 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 eventsFrom 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 eventsFrom 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 eventsFrom 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 eventsFrom the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years