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

ID#: NCT06634589

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: Phase 1/Phase 2

Recruitment Status: Recruiting

Start Date: November 27, 2024

End Date: December 02, 2029

Contact Information:
Study Director
1.877.828.5568
Summary: The purpose of this study is to measure the safety, preliminary antitumor activity, pharmacokinetics, and pharmacodynamics with BGB-16673 in combination with other agents in participants with relapsed or refractory (R/R) B-cell malignancies. This study is structured as a master protocol with separate substudies. This study currently includes four substudies, and more substudies may be added as other combination agents are identified.
Eligibility: 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.