RecruitingPhase 1Phase 2NCT05006716

A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies

A Phase 1/2, Open-Label, Dose-Escalation and -Expansion Study of the Bruton Tyrosine Kinase Targeted Protein Degrader BGB-16673 in Patients With B-Cell Malignancies

Sponsor

BeOne Medicines

Enrollment

614 participants

Start Date

Sep 13, 2021

Study Type

INTERVENTIONAL

Conditions

Diffuse Large B Cell Lymphoma Chronic Lymphocytic Leukemia Non-Hodgkin Lymphoma Mantle Cell Lymphoma Follicular Lymphoma Small Lymphocytic Lymphoma Marginal Zone Lymphoma B-cell Malignancy Waldenström Macroglobulinemia

Summary

Study consists of two main parts to explore BGB-16673 recommended dosing, a Phase 1 monotherapy dose finding comprised of monotherapy dose escalation and monotherapy safety expansion of selected doses, and a Phase 2 (expansion cohorts)

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new drug called BGB-16673 in people with certain types of blood cancers (B-cell lymphomas and leukemias) that have either relapsed after or never responded to treatments, including previous BTK inhibitor drugs (a common type of targeted therapy for these cancers). **You may be eligible if...** - You have been diagnosed with a B-cell blood cancer such as mantle cell lymphoma, follicular lymphoma, diffuse large B-cell lymphoma, CLL/SLL, or related conditions - Your cancer has relapsed or not responded to prior treatment - If you previously received a BTK inhibitor drug, you used it for at least 8 weeks (unless you stopped due to side effects) **You may NOT be eligible if...** - You have not been diagnosed with one of the qualifying blood cancer types - Your cancer has not relapsed or progressed on previous therapy - Your general health or organ function does not meet the minimum requirements 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

Orally administered

Locations(127)

University of Alabama At Birmingham Hospital

Birmingham, Alabama, United States

Mayo Clinic Phoenix

Phoenix, Arizona, United States

Honor Health Research Institute

Scottsdale, Arizona, United States

University of Arizona Cancer Center

Tucson, Arizona, United States

University of California San Diego (Ucsd) Moores Cancer Center

La Jolla, California, United States

Stanford Medicine

Palo Alto, California, United States

UCLA Santa Monica Cancer Care

Santa Monica, California, United States

Uchealth North

Fort Collins, Colorado, United States

Mayo Clinic Jacksonville

Jacksonville, Florida, United States

Mount Sinai Comprehensive Cancer Center

Miami, Florida, United States

Tampa General Hospital Cancer Institute

Tampa, Florida, United States

Augusta University

Augusta, Georgia, United States

Southeastern Regional Medical Center

Newnan, Georgia, United States

Midwestern Regional Medical Center

Zion, Illinois, United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Mary Bird Perkins Cancer Center

Baton Rouge, Louisiana, United States

American Oncology Partners of Maryland Pa

Bethesda, Maryland, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

Mayo Clinic Rochester

Rochester, Minnesota, United States

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, United States

Roswell Park Comprehensive Cancer Center

Buffalo, 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

Tennesse Oncology Chattanooga Downtown

Chattanooga, Tennessee, United States

Tennessee Oncology, Pllc Nashville

Nashville, Tennessee, United States

Md Anderson Cancer Center

Houston, Texas, United States

Virginia Commonwealth University Massey Cancer Center

Richmond, Virginia, United States

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Concord Repatriation General Hospital

Concord, New South Wales, Australia

Calvary Mater Newcastle

Waratah, New South Wales, Australia

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

St Vincents Hospital Melbourne

Fitzroy, Victoria, Australia

Austin Health

Heidelberg, Victoria, Australia

Peter Maccallum Cancer Centre

Melbourne, Victoria, Australia

The Alfred Hospital

Melbourne, Victoria, Australia

Linear Clinical Research

Nedlands, Western Australia, Australia

Perth Blood Institute

West Perth, Western Australia, Australia

Hospital Sirio Libanes Brasilia

Brasília, Brazil

Instituto de Pesquisa Em Saude Da Universidade de Caxias Do Sul

Caxias do Sul, Brazil

Hospital Erasto Gaertner

Curitiba, Brazil

Centro Gaucho Integrado de Oncologia Hospital Mae de Deus

Porto Alegre, Brazil

Hospital Ernesto Dornelles

Porto Alegre, Brazil

Real E Benemerita Associacao Portuguesa de Sao Paulo

São Paulo, Brazil

Hospital Alemao Oswaldo Cruz

São Paulo, Brazil

Instituto Dor de Pesquisa E Ensino Sao Paulo

São Paulo, Brazil

Hospital Nove de Julho Dasa

São Paulo, Brazil

Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

São Paulo, Brazil

Arthur Je Child Comprehensive Cancer Centre

Calgary, Alberta, Canada

Cross Cancer Institute

Edmonton, Alberta, Canada

British Columbia Cancer Agency the Vancouver Centre

Vancouver, British Columbia, Canada

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Chu de Quebec Universite Laval, Hopital de Lenfant Jesus, Centre Integre de Cancerologie (Cic)

Québec, Canada

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

Guangxi Medical University Cancer Hospital Wuxiang Branch

Nanning, Guangxi, China

The Fourth Hospital of Hebei Medical University East Branch

Shijiazhuang, Hebei, China

Henan Cancer Hospital

Zhengzhou, Henan, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Union Hospital of Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, China

Yichang Central Peoples Hospitaljiangnan Branch

Yichang, Hubei, China

Jiangsu Province Hospital

Nanjing, Jiangsu, China

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

The First Affiliated Hospital of Nanchang University Branch Xianghu

Nanchang, Jiangxi, China

Rui Jin Hospital Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciencestuanbo Branch

Tianjin, Tianjin Municipality, China

The First Affiliated Hospital, Zhejiang University School of Medicinechengzhan

Hangzhou, Zhejiang, China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Centre de Lutte Contre Le Cancer Institut Bergonie

Bordeaux, France

Hopital Estaing

Clermontferrand, France

Chu Henri Mondor

Créteil, France

Hopital Claude Huriez Chu Lille

Lille, France

Centre Leon Berard

Lyon, France

Institut Paoli Calmettes

Marseille, France

Chu Montpellier Hopital Saint Eloi

Montpellier, France

Hopital de La Pitie Salpetriere

Paris, France

Centre Henri Becquerel

Rouen, France

Arensia Exploratory Medicine Llc

Tbilisi, Georgia

Uniklinik Koeln (Aoer)

Cologne, Germany

Universitatsklinikum Carl Gustav Carus An Der Technischen Universitat Dresden

Dresden, Germany

Universitares Krebszentrum Leipzig

Leipzig, Germany

Universitaetsklinikum Schleswig Holstein Campus Luebeck

Lübeck, Germany

Klinikum Johannes Gutenberg Universitaet Mainz

Mainz, Germany

Klinikum Grosshadern Ludwig Maximilians Universitat Munchen

München, Germany

Universitaetsklinikum Ulm

Ulm, Germany

Policlinico Sorsola Malpighi, Aou Di Bologna

Bologna, Italy

Ospedale San Raffaele

Milan, Italy

Istituto Europeo Di Oncologia

Milan, Italy

Niguarda Cancer Center Division of Hematology

Milan, Italy

Fondazione Policlinico Universitario Agostino Gemelli

Roma, Italy

Centroricerche Cliniche Di Verona Srl

Verona, Italy

Aichi Cancer Center Hospital Clinical Oncology

Nagoya, Aichi-ken, Japan

Chiba Cancer Center

Chiba, Chiba, Japan

National Cancer Center Hospital East

Kashiwa, Chiba, Japan

Cancer Institute Hospital of Jfcr

Kotoku, Tokyo, Japan

Yokohama Municipal Citizens Hospital

Yokohama, Japan

The Institute of Oncology, Arensia Exploratory Medicine

Chisinau, Moldova

Inje University Busan Paik Hospital

BusanjinGu, Busan Gwang'yeogsi, South Korea

Pusan National University Hospital

Seogu, Busan Gwang'yeogsi, South Korea

Samsung Medical Center

GangnamGu, Seoul Teugbyeolsi, South Korea

The Catholic University of Korea, Seoul St Marys Hospital

SeochoGu, Seoul Teugbyeolsi, South Korea

Severance Hospital Yonsei University Health System

SeodaemunGu, Seoul Teugbyeolsi, South Korea

Seoul National University Hospital

Seoul, Seoul Teugbyeolsi, South Korea

Asan Medical Center

SongpaGu, Seoul Teugbyeolsi, South Korea

Hospital Universitario Vall Dhebron

Barcelona, Spain

Hospital General Universitario Gregorio Maranon

Madrid, Spain

Md Anderson Cancer Center Madrid Spain

Madrid, Spain

Hospital Universitario Fundacion Jimenez Diaz

Madrid, Spain

Hospital Universitario La Paz

Madrid, Spain

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, Spain

Hospital Clinico Universitario de Valencia

Valencia, Spain

Sahlgrenska University Hospital Hematology

Gothenburg, Sweden

Karolinska Universitetssjukhuset Solna

Stockholm, Sweden

Dokuz Eylul University

Balçova, Turkey (Türkiye)

Erciyes University

Kayseri, Turkey (Türkiye)

Sakarya Training and Research Hospital

Sakarya, Turkey (Türkiye)

Ondokuz Mayis University

Samsun, Turkey (Türkiye)

Edinburgh Cancer Centre

Edinburgh, United Kingdom

St Jamess University Hospital

Leeds, United Kingdom

Freeman Hospital

Newcastle upon Tyne, United Kingdom

Nottingham University Hospitals Nhs Trust

Nottingham, United Kingdom

Derriford Hospital

Plymouth, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT05006716

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