A Study to Investigate Safety and Effectiveness of BGB-16673 in Combination With Other Agents in Participants With Relapsed or Refractory B-Cell Malignancies
NCT ID: NCT06634589
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
80 participants
INTERVENTIONAL
2024-11-27
2029-12-02
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Substudy 2 Part 1a: Dose Escalation
Sequential cohorts of increasing dose level combinations of BGB-16673 and zanubrutinib will be evaluated in participants with selected B-cell malignancies.
BGB-16673
Administered orally
Zanubrutinib
Administered orally
Substudy 2 Part 1b: Safety Expansion
Cohorts of select dose level combinations of BGB-16673 and zanubrutinib will be evaluated in participants with selected B-cell malignancies.
BGB-16673
Administered orally
Zanubrutinib
Administered orally
Substudy 3 Part 1a: Dose Escalation
Sequential cohorts of increasing dose level combinations of BGB-16673 and mosunetuzumab will be evaluated in participants with selected B-cell malignancies.
BGB-16673
Administered orally
Mosunetuzumab
Administered subcutaneously
Substudy 3 Part 1b: Safety Expansion
Cohorts of select dose level combinations of BGB-16673 and mosunetuzumab will be evaluated in participants with selected B-cell malignancies.
BGB-16673
Administered orally
Mosunetuzumab
Administered subcutaneously
Substudy 4 Part 1a: Dose Escalation
Sequential cohorts of increasing dose level combinations of BGB-16673 and glofitamab will be evaluated in participants with selected B-cell malignancies. Participants will receive obinutuzumab as pretreatment prior to the start of combination treatment.
BGB-16673
Administered orally
Glofitamab
Administered intravenously
Obinutuzumab
Administered intravenously
Substudy 4 Part 1b: Safety Expansion
Cohorts of select dose level combinations of BGB-16673 and glofitamab will be evaluated in participants with selected B-cell malignancies.
BGB-16673
Administered orally
Glofitamab
Administered intravenously
Obinutuzumab
Administered intravenously
Substudy 1 Part 1a: Dose Escalation
Sequential cohorts of increasing dose level combinations of BGB-16673 and sonrotoclax will be evaluated in participants with selected B-cell malignancies.
BGB-16673
Administered orally
Sonrotoclax
Administered orally
Substudy 1 Part 1b: Safety Expansion
Cohorts of select dose level combinations of BGB-16673 and sonrotoclax will be evaluated in participants with selected B-cell malignancies.
BGB-16673
Administered orally
Sonrotoclax
Administered orally
Interventions
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BGB-16673
Administered orally
Sonrotoclax
Administered orally
Zanubrutinib
Administered orally
Mosunetuzumab
Administered subcutaneously
Glofitamab
Administered intravenously
Obinutuzumab
Administered intravenously
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 30 days after the last dose of BGB-16673 or zanubrutinib, 60 days after the last dose of glofitamab, or 90 days after the last dose of sonrotoclax or 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 30 days after the last dose of BGB-16673 or zanubrutinib, 60 days after the last dose of glofitamab, or 90 days after the last dose of sonrotoclax or 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 Criteria
* 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
* 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 BGB-16673, 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
18 Years
ALL
No
Sponsors
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BeOne Medicines
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
BeOne Medicines
Locations
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Mayo Clinic Phoenix
Phoenix, Arizona, United States
University of Southern Californianorris 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
Summit Medical Group
Florham Park, New Jersey, United States
Icahn School of Medicine At Mount Sinai
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
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
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
North Shore Hospital
Auckland, , New Zealand
Auckland City Hospital
Auckland, , New Zealand
Narodowy Instytut Onkologii Im Marii Sklodowskiej Curie Hematology Unit
Warsaw, , Poland
Countries
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Central Contacts
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Other Identifiers
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2024-516234-35-00
Identifier Type: CTIS
Identifier Source: secondary_id
CTR20244676
Identifier Type: REGISTRY
Identifier Source: secondary_id
BGB-16673-104
Identifier Type: -
Identifier Source: org_study_id