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

Trial Title: 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

Condition: B-cell Malignancy
Relapsed Cancer
Refractory Cancer
B-cell Lymphoma

Conditions: Official terms:
Neoplasms
Lymphoma, B-Cell
Zanubrutinib

Conditions: Keywords:
R/R B-Cell Malignancies
relapsed or refractory B-Cell Malignancies
B-Cell malignancy
BGB-16673
sonrotoclax
zanubrutinib
B-cell lymphoma
Bruton Tyrosine Kinase (BTK)

Study type: Interventional

Study phase: Phase 1/Phase 2

Overall status: Not yet recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: BGB-16673
Description: Administered orally
Arm group label: Substudy 1 Part 1a: Dose Escalation
Arm group label: Substudy 1 Part 1b: Safety Expansion
Arm group label: Substudy 2 Part 1a: Dose Escalation
Arm group label: Substudy 2 Part 1b: Safety Expansion

Intervention type: Drug
Intervention name: sonrotoclax
Description: Administered orally
Arm group label: Substudy 1 Part 1a: Dose Escalation
Arm group label: Substudy 1 Part 1b: Safety Expansion

Other name: BGB-11417

Intervention type: Drug
Intervention name: Zanubrutinib
Description: Administered orally
Arm group label: Substudy 2 Part 1a: Dose Escalation
Arm group label: Substudy 2 Part 1b: Safety Expansion

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 will initially include two substudies, and more substudies may be added as they become available.

Detailed description: 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, and with zanubrutinib in substudy 2.

Criteria for 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, or 90 days after the last dose of sonrotoclax. 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, or 90 days after the last dose of sonrotoclax - 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 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 and 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 allogeneic stem cell transplant with active graft-versus-host disease (GVHD), or requiring immunosuppressive drugs for treatment of GVHD, or 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, or zanubrutinib - Substudy 1 Exclusion Criterion: - Prior treatment with a B-cell lymphoma-2 (Bcl-2) inhibitor - Substudy 2 Exclusion Criterion: - Participants who discontinued prior zanubrutinib treatment due to intolerance Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Start date: December 2, 2024

Completion date: December 2, 2029

Lead sponsor:
Agency: BeiGene
Agency class: Industry

Source: BeiGene

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06634589