RecruitingPhase 1Phase 2NCT06634589

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

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

Sponsor

BeOne Medicines

Enrollment

80 participants

Start Date

Nov 27, 2024

Study Type

INTERVENTIONAL

Conditions

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

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called BGB-16673 — alone and in combination with other cancer drugs — for people with relapsed or refractory B-cell blood cancers (cancers that have come back or stopped responding to prior treatments). B-cell cancers include types of lymphoma and leukemia. The study is divided into sub-groups (substudies) testing different drug combinations. **You may be eligible if...** - You are 18 or older with a confirmed diagnosis of a relapsed or refractory B-cell blood cancer - You have measurable disease and your general physical status allows participation (ECOG 0–2) - Your organ function (kidneys, liver, blood counts) meets the required minimum levels - You are willing to use effective contraception during and after the study **You may NOT be eligible if...** - Your cancer has never been treated before (treatment-naive) - You have active brain or spinal fluid involvement by cancer - You have had another cancer diagnosis within the past 2 years (with limited exceptions) - You had a stem cell transplant or CAR-T therapy within the past 3 months - You have a history of severe allergic reactions to any of the study drugs - You have active graft-versus-host disease (from a prior transplant) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBGB-16673

Administered orally

DRUGSonrotoclax

Administered orally

DRUGZanubrutinib

Administered orally

DRUGMosunetuzumab

Administered subcutaneously

DRUGGlofitamab

Administered intravenously

DRUGObinutuzumab

Administered intravenously

Locations(50)

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

Medizinische Universitaetsklinik

Tübingen, 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

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NCT06634589

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