A Study to Investigate Safety and Effectiveness of BGB-16673 in Combination With Other Agents in Participants With Relapsed or Refractory B-Cell Malignancies

Launched by BEIGENE · Oct 8, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called BGB-16673, used alongside other medications, for patients with certain types of B-cell cancers that have either returned after treatment or did not respond to previous therapies. The goal is to find out how safe this treatment is and whether it can help shrink tumors. The study is currently looking for participants aged 65 and older who have been diagnosed with these specific cancers and can provide informed consent, meaning they understand the study and agree to participate.

Participants will need to meet several criteria to join the trial, such as having measurable disease and acceptable organ function. Women of childbearing age and men must agree to use effective birth control during the study and for some time afterward. Throughout the trial, participants will receive the new treatment and will be monitored for its effects. They should be prepared for regular check-ins and tests to assess their health and the treatment's impact on their cancer. This study is important as it could lead to new options for patients facing difficult-to-treat B-cell malignancies.

Gender

ALL

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 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
• • 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
• • 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
• • Note: Other protocol defined Inclusion/Exclusion criteria may apply.