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RECRUITING

NCT06634589

PHASE1/PHASE2

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: BeOne Medicines

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-11-27

Completion Date

2029-12-02

Last Updated

2026-03-18

Healthy Volunteers

Conditions

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

Interventions

DRUG

BGB-16673

Administered orally

DRUG

Sonrotoclax

Administered orally

DRUG

Zanubrutinib

Administered orally

DRUG

Mosunetuzumab

Administered subcutaneously

DRUG

Glofitamab

Administered intravenously

DRUG

Obinutuzumab

Administered intravenously

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, 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 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 * 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 Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Locations (49)

Mayo Clinic Phoenix

Phoenix, Arizona, United States

University of Southern Californianorris Comprehensive

Los Angeles, California, United States

Mayo Clinic Jacksonville

Jacksonville, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

The University of Kansas Cancer Center

Westwood, Kansas, United States

Mayo Clinic Rochester

Rochester, Minnesota, United States

Washington University School of Medicine

St Louis, Missouri, United States

Summit Medical Group

Florham Park, New Jersey, United States

Icahn School of Medicine At Mount Sinai

New York, New York, United States

Columbia University Medical Center

New York, New York, United States

Weill Cornell Medical College Newyork Presbyterian Hospital

New York, New York, United States

Memorial Sloan Kettering Cancer Center Mskcc

New York, New York, United States

University of Rochester

Rochester, New York, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

The University of Texas Md Anderson Cancer Center

Houston, Texas, United States

Huntsman Cancer Institute

Salt Lake City, Utah, United States

University of Wisconsin

Madison, Wisconsin, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

St George Hospital

Kogarah, New South Wales, Australia

Mater Cancer Care Centre

South Brisbane, Queensland, Australia

Monash Health

Clayton, Victoria, Australia

Peter Maccallum Cancer Centre

Melbourne, Victoria, Australia

The Alfred Hospital

Melbourne, Victoria, Australia

Linear Clinical Research

Nedlands, Western Australia, Australia

Hospital Sirio Libanes Brasilia

Brasília, Brazil

Ensino E Terapia de Inovacao Clinica Amo Etica

Salvador, Brazil

Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto

São José do Rio Preto, Brazil

Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

São Paulo, Brazil

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Sun Yat Sen University Cancer Center

Guangzhou, Guangdong, China

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

The First Affiliated Hospital, Zhejiang University School of Medicinechengzhan

Hangzhou, Zhejiang, China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Universitatsklinikum Carl Gustav Carus An Der Technischen Universitat Dresden

Dresden, Germany

Universitatsklinikum Jena Klinik Fur Innere Medizin Ii

Jena, Germany

Universitatsklinikum Schleswig Holstein, Campus Kiel

Kiel, Germany

Universitaetsklinikum Ulm

Ulm, Germany

Azienda Ospedaliera Universitaria Policlinico Santorsola Malpighi

Bologna, Italy

Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

Milan, Italy

Istituto Nazionale Tumori Fondazione G Pascale

Naples, Italy

Istituto Clinico Humanitas

Rozzano, Italy

Centroricerche Cliniche Di Verona Srl

Verona, Italy

North Shore Hospital

Auckland, New Zealand

Auckland City Hospital

Auckland, New Zealand

Uniwersyteckie Centrum Kliniczne

Gdansk, Poland

Uniwersytecki Szpital Kliniczny Nr 1 W Lublinie

Lublin, Poland

Szpital Kliniczny Mswia Z Warmisko Mazurskim Centrum Onkologii

Olsztyn, Poland

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

Opole, Poland

Narodowy Instytut Onkologii Im Marii Sklodowskiej Curie Hematology Unit

Warsaw, Poland

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (49)