RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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

Quick Facts

Study Start:2024-11-27
Study Completion:2029-12-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06634589

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * Confirmed diagnosis of a R/R B-cell malignancy
  3. * Protocol-defined measurable disease
  4. * Stable Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
  5. * Adequate organ function
  6. * 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
  7. * 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
  8. * Substudies 1, 3, and 4 Inclusion Criterion:
  9. * Adequate renal function as indicated by estimated glomerular filtration rate (eGFR) of ≥ 50 mL/min
  10. * Substudy 2
  1. * Treatment-naive B-cell malignancies
  2. * Unable to comply with the requirements of the protocol
  3. * Active leptomeningeal disease or uncontrolled, untreated brain metastasis
  4. * 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
  5. * Autologous stem cell transplant ≤ 3 months prior to screening or chimeric antigen T-cell therapy ≤ 3 months prior to screening
  6. * 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
  7. * 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
  8. * Substudy 1 Exclusion Criterion:
  9. * 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)
  10. * Substudy 2 Exclusion Criterion:
  11. * Participants who discontinued prior zanubrutinib treatment due to intolerance
  12. * Substudies 3 and 4

Contacts and Locations

Study Contact

Study Director
CONTACT
1.877.828.5568
clinicaltrials@beigene.com

Principal Investigator

Study Director
STUDY_DIRECTOR
BeiGene

Study Locations (Sites)

Mayo Clinic Phoenix
Phoenix, Arizona, 85254
United States
University of Southern Californianorris Comprehensive
Los Angeles, California, 90033
United States
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
United States
Moffitt Cancer Center
Tampa, Florida, 33612-9497
United States
The University of Kansas Cancer Center
Westwood, Kansas, 66205
United States
University of Michigan Health System
Ann Arbor, Michigan, 48109
United States
Mayo Clinic Rochester
Rochester, Minnesota, 55905
United States
Washington University School of Medicine
Saint Louis, Missouri, 63110
United States
Summit Medical Group
Florham Park, New Jersey, 07932
United States
Weill Cornell Medical College Newyork Presbyterian Hospital
New York, New York, 10021
United States
Icahn School of Medicine At Mount Sinai
New York, New York, 10029
United States
Memorial Sloan Kettering Cancer Center Mskcc
New York, New York, 10065
United States
University of Rochester
Rochester, New York, 14642
United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
United States
The University of Texas Md Anderson Cancer Center
Houston, Texas, 77030-4009
United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
United States
University of Wisconsin
Madison, Wisconsin, 53792
United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: BeiGene

  • Study Director, STUDY_DIRECTOR, BeiGene

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-27
Study Completion Date2029-12-02

Study Record Updates

Study Start Date2024-11-27
Study Completion Date2029-12-02

Terms related to this study

Keywords Provided by Researchers

  • 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)
  • Mosunetuzumab
  • Glofitamab

Additional Relevant MeSH Terms

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