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

Last updated: March 20, 2025
Sponsor: BeiGene
Overall Status: Active - Recruiting

Phase

1/2

Condition

Lymphoma, B-cell

Lymphoproliferative Disorders

Hematologic Cancer

Treatment

BGB-16673

sonrotoclax

Mosunetuzumab

Clinical Study ID

NCT06634589
BGB-16673-104
CTR20244676
2024-516234-35-00
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Key Inclusion Criteria:

  • Must sign the informed consent form (ICF) and be capable of giving written informedconsent, which includes compliance with the requirements and restrictions listed inthe 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 highlyeffective method of birth control and refrain from egg donation for the duration ofthe study and for 30 days after the last dose of BGB-16673 or zanubrutinib, 60 daysafter the last dose of glofitamab, or 90 days after the last dose of sonrotoclax ormosunetuzumab. 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 ofbirth 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 lastdose 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 treatmentwith a covalent BTK inhibitor and discontinued for reasons other than clinicalprogression

  • Adequate renal function as indicated by eGFR of ≥ 30 mL/min

Exclusion

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 thespecific cancer under investigation in this study or any locally recurring cancerthat has been treated curatively

  • Autologous stem cell transplant ≤ 3 months prior to screening or chimeric antigenT-cell therapy ≤ 3 months prior to screening

  • Substudies 1 and 2: Prior allogeneic stem cell transplant with activegraft-versus-host disease (GVHD), or requiring immunosuppressive drugs for treatmentof GVHD, or who have taken calcineurin inhibitors within 4 weeks prior to consent

  • Participants who have a history of severe allergic reactions or hypersensitivity tothe 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 forparticipants who relapsed ≥ 24 months after completion of a full course of aprior 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.

Study Design

Total Participants: 80
Treatment Group(s): 7
Primary Treatment: BGB-16673
Phase: 1/2
Study Start date:
November 27, 2024
Estimated Completion Date:
December 02, 2029

Study 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, zanubrutinib in substudy 2, mosunetuzumab in substudy 3, and glofitamab in substudy 4.

Connect with a study center

  • St George Hospital

    Kogarah, New South Wales 2217
    Australia

    Active - Recruiting

  • Mater Cancer Care Centre

    South Brisbane, Queensland 4101
    Australia

    Active - Recruiting

  • Monash Health

    Clayton, Victoria 3168
    Australia

    Site Not Available

  • Peter Maccallum Cancer Centre

    Melbourne, Victoria 3000
    Australia

    Active - Recruiting

  • The Alfred Hospital

    Melbourne, Victoria 3004
    Australia

    Site Not Available

  • Linear Clinical Research

    Nedlands, Western Australia 6009
    Australia

    Active - Recruiting

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian 350001
    China

    Site Not Available

  • Sun Yat Sen University Cancer Center

    Guangzhou, Guangdong 510060
    China

    Site Not Available

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu 215006
    China

    Site Not Available

  • The First Affiliated Hospital, Zhejiang University School of Medicinechengzhan

    Hangzhou, Zhejiang 310002
    China

    Active - Recruiting

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang 325000
    China

    Site Not Available

  • Universitatsklinikum Carl Gustav Carus An Der Technischen Universitat Dresden

    Dresden, 01307
    Germany

    Site Not Available

  • Universitatsklinikum Jena Klinik Fur Innere Medizin Ii

    Jena, 07747
    Germany

    Site Not Available

  • Universitatsklinikum Schleswig Holstein, Campus Kiel

    Kiel, 24105
    Germany

    Site Not Available

  • Medizinische Universitaetsklinik

    Tuebingen, 72076
    Germany

    Site Not Available

  • Universitaetsklinikum Ulm, Innere Medizin Iii

    Ulm, 89081
    Germany

    Site Not Available

  • Azienda Ospedaliera Universitaria Policlinico Santorsola Malpighi

    Bologna, 40138
    Italy

    Site Not Available

  • Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

    Milano, 20162
    Italy

    Site Not Available

  • Istituto Nazionale Tumori Fondazione G Pascale

    Napoli, 80131
    Italy

    Site Not Available

  • Istituto Clinico Humanitas

    Rozzano, 20089
    Italy

    Site Not Available

  • Centro Ricerche Cliniche Di Verona

    Verona, 37134
    Italy

    Site Not Available

  • Auckland City Hospital

    Auckland, 1023
    New Zealand

    Active - Recruiting

  • North Shore Hospital

    Takapuna, 0622
    New Zealand

    Site Not Available

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-952
    Poland

    Site Not Available

  • Samodzielny Publiczny Szpital Kliniczny Nr W Lublinie

    Lublin, 20-081
    Poland

    Site Not Available

  • Szpital Kliniczny Mswia Z Warminsko Mazurskim Centrum Onkologii

    Olsztyn, 10-228
    Poland

    Site Not Available

  • Szpital Kliniczny Mswia Z Warmisko Mazurskim Centrum Onkologii

    Olsztyn, 10-228
    Poland

    Site Not Available

  • Szpital Wojewodzki W Opolu Sp Z Oo Oddzia Hematologii I Onkologii Hematologicznej

    Opole, 45-061
    Poland

    Site Not Available

  • Narodowy Instytut Onkologii Im Marii Skodowskiej Curie Hematology Unit

    Warsaw, 02-781
    Poland

    Site Not Available

  • Mayo Clinic Phoenix

    Phoenix, Arizona 85254
    United States

    Site Not Available

  • University of Southern Californianorris Comprehensive

    Los Angeles, California 90033
    United States

    Site Not Available

  • Mayo Clinic Jacksonville

    Jacksonville, Florida 32224
    United States

    Site Not Available

  • Moffitt Cancer Center

    Tampa, Florida 33612-9497
    United States

    Active - Recruiting

  • The University of Kansas Cancer Center

    Westwood, Kansas 66205
    United States

    Site Not Available

  • University of Michigan Health System

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • Mayo Clinic Rochester

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

  • Summit Medical Group

    Florham Park, New Jersey 07932
    United States

    Active - Recruiting

  • Icahn School of Medicine At Mount Sinai

    New York, New York 10029
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center Mskcc

    New York, New York 10065
    United States

    Site Not Available

  • Weill Cornell Medical College Newyork Presbyterian Hospital

    New York, New York 10021
    United States

    Site Not Available

  • University of Rochester

    Rochester, New York 14642
    United States

    Site Not Available

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania 19111
    United States

    Active - Recruiting

  • The University of Texas Md Anderson Cancer Center

    Houston, Texas 77030-4009
    United States

    Site Not Available

  • Huntsman Cancer Institute

    Salt Lake City, Utah 84112
    United States

    Site Not Available

  • University of Wisconsin

    Madison, Wisconsin 53792
    United States

    Site Not Available

  • Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.