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

Description

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.

Conditions

B-cell Malignancy, Relapsed Cancer, Refractory Cancer, B-cell Lymphoma

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
B-cell Malignancy
Intervention / Treatment

-

Contacts and Locations

Phoenix

Mayo Clinic Phoenix, Phoenix, Arizona, United States, 85254

Los Angeles

University of Southern Californianorris Comprehensive, Los Angeles, California, United States, 90033

Jacksonville

Mayo Clinic Jacksonville, Jacksonville, Florida, United States, 32224

Tampa

Moffitt Cancer Center, Tampa, Florida, United States, 33612-9497

Westwood

The University of Kansas Cancer Center, Westwood, Kansas, United States, 66205

Ann Arbor

University of Michigan Health System, Ann Arbor, Michigan, United States, 48109

Rochester

Mayo Clinic Rochester, Rochester, Minnesota, United States, 55905

Saint Louis

Washington University School of Medicine, Saint Louis, Missouri, United States, 63110

Florham Park

Summit Medical Group, Florham Park, New Jersey, United States, 07932

New York

Weill Cornell Medical College Newyork Presbyterian Hospital, New York, New York, United States, 10021

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

BeiGene,

Study Director, STUDY_DIRECTOR, BeiGene

Study Record Dates

2029-12-02