Last updated 9 days ago
A Study to Investigate Safety and Effectiveness of BGB-16673 in Combination With Other Agents in Participants With Relapsed or Refractory B-Cell Malignancies
80 patients around the world
Available in Brazil, United States
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.
BeiGene
4Research sites
80Patients around the world
This study is for people with
Non-Hodgkin Lymphoma
B-cell lymphoma
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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 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.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.Substudy 2 Inclusion Criteria: Adequate renal function as indicated by eGFR of ≥ 30 mL/min.
- 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.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.Substudies 3 and 4 Exclusion Criteria: All participants with a prior allogeneic stem cell transplant.
Sites
Hospital Sírio- Libanês Brasilia
Clínica AMO
Fundação Faculdade Regional de Medicina de São José do Rio Preto
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
SponsorBeiGene
Study typeInterventional
Conditions
B-cell lymphoma
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06634589
