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NCT06634589PHASE1, PHASE2Recruiting

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

BeOne Medicines

Start Date

11/27/2024

Completion Date

12/2/2029

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.

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, zanubrutinib in substudy 2, mosunetuzumab in substudy 3, and glofitamab in substudy 4. Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.

Eligibility Criteria

Age Range: 18 years to No maximum

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 ≥ 7 days after the last dose of sonrotoclax, 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 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 ≥ 7 days after the last dose of sonrotoclax, 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 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 treatment with a covalent BTK inhibitor and discontinued for reasons other than clinical progression * Adequate renal function as indicated by eGFR of ≥ 30 mL/min 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 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 * Prior invasive fungal infection, except if participant agrees to receive secondary antifungal prophylaxis during the entire treatment period * 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 Exclusion Criteria: * Prior exposure to a CD20 x CD3 T-cell engager antibody treatment * All participants with a prior allogeneic stem cell transplant * Participants with known contraindications to azole antifungal agents, including hypersensitivity reactions Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Interventions

DRUG

BGB-16673

DRUG

Sonrotoclax

DRUG

Zanubrutinib

DRUG

Mosunetuzumab

DRUG

Glofitamab

DRUG

Obinutuzumab

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

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Conditions

B-cell MalignancyRelapsed CancerRefractory CancerB-cell Lymphoma

Locations

Mayo Clinic Phoenix

Phoenix, Arizona 85054-4502

United States

University of Southern California Norris Comprehensive

Los Angeles, California 90033

United States

Mayo Clinic Jacksonville

Jacksonville, Florida 32224-1865

United States

Moffitt Cancer Center

Tampa, Florida 33612-9496

United States

The University of Kansas Cancer Center

Westwood, Kansas 66205-2003

United States

Mayo Clinic Rochester

Rochester, Minnesota 55905-0001

United States

Washington University School of Medicine

St Louis, Missouri 63110-1010

United States

Summit Medical Group

Florham Park, New Jersey 07932-1049

United States

Icahn School of Medicine At Mount Sinai

New York, New York 10029-6504

United States

Columbia University Medical Center

New York, New York 10032

United States

Weill Cornell Medical College Newyork Presbyterian Hospital

New York, New York 10065-4870

United States

Memorial Sloan Kettering Cancer Center Mskcc

New York, New York 10065-6800

United States

University of Rochester

Rochester, New York 14642-0001

United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania 19111-2434

United States

The University of Texas Md Anderson Cancer Center

Houston, Texas 77030-4009

United States

Huntsman Cancer Institute

Salt Lake City, Utah 84112-5550

United States

University of Wisconsin

Madison, Wisconsin 53792-0001

United States

Medical College of Wisconsin

Milwaukee, Wisconsin 53226-3522

United States

St George Hospital

Kogarah, New South Wales NSW 2217

Australia

Mater Cancer Care Centre

South Brisbane, Queensland QLD 4101

Australia

Monash Health

Clayton, Victoria VIC 3168

Australia

Peter Maccallum Cancer Centre

Melbourne, Victoria VIC 3000

Australia

The Alfred Hospital

Melbourne, Victoria VIC 3004

Australia

Linear Clinical Research

Nedlands, Western Australia WA 6009

Australia

Hospital Sirio Libanes Brasilia

Brasília, 70200-730

Brazil

Ensino E Terapia de Inovacao Clinica Amo Etica

Salvador, 41950-640

Brazil

Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto

São José do Rio Preto, 15090-000

Brazil

Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

São Paulo, 05652-900

Brazil

Fujian Medical University Union Hospital

Fuzhou, Fujian 350001

China

Sun Yat Sen University Cancer Center

Guangzhou, Guangdong 510060

China

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu 215006

China

The First Affiliated Hospital, Zhejiang University School of Medicinechengzhan

Hangzhou, Zhejiang 310002

China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang 325000

China

Universitatsklinikum Carl Gustav Carus An Der Technischen Universitat Dresden

Dresden, 01307

Germany

Universitatsklinikum Jena Klinik Fur Innere Medizin Ii

Jena, 07747

Germany

Universitatsklinikum Schleswig Holstein Campus Kiel

Kiel, 24105

Germany

Medizinische Universitaetsklinik

Tübingen, 72076

Germany

Universitaetsklinikum Ulm

Ulm, 89081

Germany

Azienda Ospedaliera Universitaria Policlinico Santorsola Malpighi

Bologna, 40138

Italy

Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

Milan, 20162

Italy

Istituto Nazionale Tumori Fondazione G Pascale

Naples, 80131

Italy

Istituto Clinico Humanitas

Rozzano, 20089

Italy

Centroricerche Cliniche Di Verona Srl

Verona, 37134

Italy

North Shore Hospital

Auckland, 0622

New Zealand

Auckland City Hospital

Auckland, 1023

New Zealand

Uniwersyteckie Centrum Kliniczne

Gdansk, 80-214

Poland

Uniwersytecki Szpital Kliniczny Nr 1 W Lublinie

Lublin, 20-081

Poland

Szpital Kliniczny Mswia Z Warmisko Mazurskim Centrum Onkologii

Olsztyn, 10-228

Poland

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

Opole, 45-061

Poland

Narodowy Instytut Onkologii Im Marii Sklodowskiej Curie W Warszawie

Warsaw, 02-781

Poland