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NCT06634589 | NOT YET RECRUITING | B-cell Malignancy

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

BeiGene

Brief 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.

Condition or disease

B-cell Malignancy

Relapsed Cancer

Refractory Cancer

B-cell Lymphoma

Intervention/treatment

BGB-16673

sonrotoclax

Zanubrutinib

Phase

PHASE1

PHASE2

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 170 participants
Masking : NONE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2024-12-02
Estimated Primary Completion Date : 2028-12-02
Estimated Study Completion Date : 2029-12-02

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
A Study to Investigate Safety and Effectiveness of BGB-16673 in Combination With Other Agents in Participants With Relapsed or Refractory B-Cell Malignancies

Location Details

NCT06634589

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