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A Study to Investigate Safety and Effectiveness of BGB-16673 in Combination With Other Agents in Participants With Relapsed or Refractory B-Cell Malignancies
NCT06634589 · BeOne Medicines
In plain English
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Official title
A Phase 1b/2, Open-Label, Master Protocol Study of BTK-Degrader BGB-16673 in Combination With Other Agents in Patients With Relapsed or Refractory B-Cell Malignancies
About this study
This new study will check how safe and helpful a potential anticancer drug called BGB-16673 is in participants with R/R B-cell malignancies when it is given in combination with other medicines - sonrotoclax in substudy 1, zanubrutinib in substudy 2, mosunetuzumab in substudy 3, and glofitamab in substudy 4.
Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.
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 BGB-16673 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 BGB-16673 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 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
* 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.
Study design
Enrollment target: 80 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-11-27
Estimated completion: 2029-12-02
Last updated: 2026-06-03
Interventions
Drug: BGB-16673Drug: SonrotoclaxDrug: ZanubrutinibDrug: MosunetuzumabDrug: GlofitamabDrug: Obinutuzumab
Primary outcomes
- • 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)
Sponsor
BeOne Medicines · industry
Contacts & investigators
ContactStudy Director · contact · clinicaltrials@beonemed.com · 1.877.828.5568
InvestigatorStudy Director · study_director, BeOne Medicines
All locations (50)
Mayo Clinic PhoenixRecruiting
Phoenix, Arizona, United States
University of Southern California Norris ComprehensiveRecruiting
Los Angeles, California, United States
Mayo Clinic JacksonvilleRecruiting
Jacksonville, Florida, United States
Moffitt Cancer CenterRecruiting
Tampa, Florida, United States
The University of Kansas Cancer CenterRecruiting
Westwood, Kansas, United States
Mayo Clinic RochesterRecruiting
Rochester, Minnesota, United States
Washington University School of MedicineRecruiting
St Louis, Missouri, United States
Summit Medical GroupRecruiting
Florham Park, New Jersey, United States
Icahn School of Medicine At Mount SinaiRecruiting
New York, New York, United States
Columbia University Medical CenterRecruiting
New York, New York, United States
Weill Cornell Medical College Newyork Presbyterian HospitalRecruiting
New York, New York, United States
Memorial Sloan Kettering Cancer Center MskccRecruiting
New York, New York, United States
University of RochesterRecruiting
Rochester, New York, United States
Fox Chase Cancer CenterRecruiting
Philadelphia, Pennsylvania, United States
The University of Texas Md Anderson Cancer CenterRecruiting
Houston, Texas, United States
Huntsman Cancer InstituteRecruiting
Salt Lake City, Utah, United States
University of WisconsinRecruiting
Madison, Wisconsin, United States
Medical College of WisconsinRecruiting
Milwaukee, Wisconsin, United States
St George HospitalRecruiting
Kogarah, New South Wales, Australia
Mater Cancer Care CentreRecruiting
South Brisbane, Queensland, Australia
Monash HealthRecruiting
Clayton, Victoria, Australia
Peter Maccallum Cancer CentreRecruiting
Melbourne, Victoria, Australia
The Alfred HospitalRecruiting
Melbourne, Victoria, Australia
Linear Clinical ResearchRecruiting
Nedlands, Western Australia, Australia
Hospital Sirio Libanes BrasiliaRecruiting
Brasília, Brazil
Ensino E Terapia de Inovacao Clinica Amo EticaRecruiting
Salvador, Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio PretoRecruiting
São José do Rio Preto, Brazil
Sociedade Beneficente Israelita Brasileira Hospital Albert EinsteinRecruiting
São Paulo, Brazil
Fujian Medical University Union HospitalRecruiting
Fuzhou, Fujian, China
Sun Yat Sen University Cancer CenterRecruiting
Guangzhou, Guangdong, China
The First Affiliated Hospital of Soochow UniversityRecruiting
Suzhou, Jiangsu, China
The First Affiliated Hospital, Zhejiang University School of MedicinechengzhanRecruiting
Hangzhou, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical UniversityRecruiting
Wenzhou, Zhejiang, China
Universitatsklinikum Carl Gustav Carus An Der Technischen Universitat DresdenRecruiting
Dresden, Germany
Universitatsklinikum Jena Klinik Fur Innere Medizin IiRecruiting
Jena, Germany
Universitatsklinikum Schleswig Holstein Campus KielRecruiting
Kiel, Germany
Medizinische UniversitaetsklinikRecruiting
Tübingen, Germany
Universitaetsklinikum UlmRecruiting
Ulm, Germany
Azienda Ospedaliera Universitaria Policlinico Santorsola MalpighiRecruiting
Bologna, Italy
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano NiguardaRecruiting
Milan, Italy
Istituto Nazionale Tumori Fondazione G PascaleRecruiting
Naples, Italy
Istituto Clinico HumanitasRecruiting
Rozzano, Italy
Centroricerche Cliniche Di Verona SrlRecruiting
Verona, Italy
North Shore HospitalRecruiting
Auckland, New Zealand
Auckland City HospitalRecruiting
Auckland, New Zealand
Uniwersyteckie Centrum KliniczneRecruiting
Gdansk, Poland
Uniwersytecki Szpital Kliniczny Nr 1 W LublinieRecruiting
Lublin, Poland
Szpital Kliniczny Mswia Z Warmisko Mazurskim Centrum OnkologiiRecruiting
Olsztyn, Poland
Szpital Wojewodzki W Opolu Sp Z Oo Oddzia Hematologii I Onkologii HematologicznejRecruiting
Opole, Poland
Narodowy Instytut Onkologii Im Marii Sklodowskiej Curie Hematology UnitRecruiting
Warsaw, Poland