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NCT05006716PHASE1, PHASE2Recruiting

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

BeOne Medicines

Start Date

9/13/2021

Completion Date

11/1/2029

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)

Detailed Description

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

Inclusion Criteria : 1. Confirmed diagnosis (per World Health Organization (WHO) guidelines, unless otherwise noted) of one of the following: Marginal Zone Lymphoma (MZL), R/R follicular lymphoma (FL), mantle cell lymphoma (MCL), chronic lymphocytic leukemia and small lymphocytic lymphoma (CLL/SLL), Waldenström macroglobulinemia (WM), R/R diffuse large B-cell lymphoma (DLBCL), or Richter's transformation to DLBCL. 2. Participants who have previously received a covalently-binding Bruton´s tyrosine kinase (BTK) inhibitor (BTKi) in any line of therapy must have received treatment with the BTK inhibitor for ≥ 8 weeks (unless reason for discontinuation is intolerance). 3. For dose-finding and dose-expansion, participants who had previously received a covalently-binding BTK inhibitor as monotherapy or in combination with other anticancer agents are eligible for the study if they meet any of the following criteria: discontinued the previous BTK inhibitor due to disease progression, experienced disease progression after completing treatment with a BTK inhibitor or discontinued the BTK inhibitor due to toxicity or intolerance. 4. Phase 2 Cohorts in R/R CLL/SLL, R/R MCL, and R/R WM only: Participants who previously received a BTKi are eligible if they had disease progression on only one regimen containing a covalent BTKi. Note: Participants may have received treatment with ≥ 2 different covalent BTKis if additional BTKis were discontinued secondary to an event other than disease progression. 5. Measurable disease by radiographic assessment or serum IgM level (WM only) 6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2 7. Participants enrolling in the dose finding phase of the study may be previously treated with a BTKi or may be naïve to BTKi therapy depending on the diagnosis and country of enrollment; participants with MCL enrolling in the expansion cohorts (Phase 2) must have been treated with a BTKi in a prior line of therapy; CLL/SLL participants, in addition to being treated with a BTKi in a prior line of therapy, must also have received a Bcl-2 inhibitor in a prior line of therapy as well (Phase 2). Exclusion Criteria: 1. Prior malignancy (other than the disease under study) within the past 2 years, except in situ malignancies that have been curatively resected, localized breast cancer treated with curative intent with no evidence of breast active disease for more than 3 years and receiving adjuvant hormonal therapy, localized Gleason score ≤ 6 prostate cancer undergoing observation or treatment with androgen depravation, or any other cancer treated with curative intent, not on adjuvant treatment, and in the opinion of the investigator is unlikely to recur. 2. Requires ongoing systemic treatment for any other malignancy 3. Requires ongoing systemic (defined as ≥ 10 mg/day of prednisone or equivalent) corticosteroid treatment. 4. Current or history of central nervous system involvement including the brain, spinal cord, leptomeninges, and cerebrospinal fluid (as documented by imaging, cytology, or biopsy) by B-cell malignancy, regardless of whether participants had received treatment for central nervous system disease 5. Known active plasma cell neoplasm, prolymphocytic leukemia, T-cell lymphoma, Burkitt lymphoma, acquired immunodeficiency syndrome (AIDS)-related B-cell lymphoma, Castleman disease, post-transplant lymphoproliferative disorders, hairy cell leukemia, germinal center B-cell (GCB), DLBCL, EBV+ DLBCL NOS, primary DLBCL of the central nervous system (CNS), primary cutaneous DLBCL - leg type, DLBCL associated with chronic inflammation, primary mediastinal (thymic) large B-cell lymphoma, intravascular large B-cell lymphoma, ALK+ large B-cell lymphoma, primary effusion lymphoma, high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements, high-grade B-cell lymphoma - NOS, B-cell lymphoma unclassifiable with features intermediate between DLBCL and classical Hodgkin lymphoma, or history of or currently suspected transformation of an indolent lymphoma to an aggressive histology (except for participants with Richter Transformation to DLBCL are eligible for Part 1a, 1c, or Phase 2 and participants with history of follicular lymphoma transforming to non-GCB DLBCL who are eligible for Part 1a, 1c, or Phase 2). Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Interventions

DRUG

BGB-16673

Interested in This Trial?

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Conditions

B-cell MalignancyMarginal Zone LymphomaFollicular LymphomaNon-Hodgkin LymphomaWaldenström MacroglobulinemiaChronic Lymphocytic LeukemiaSmall Lymphocytic LymphomaMantle Cell LymphomaDiffuse Large B Cell Lymphoma

Locations

University of Alabama At Birmingham Hospital

Birmingham, Alabama 35294-0004

United States

Mayo Clinic Phoenix

Phoenix, Arizona 85054-4502

United States

Honor Health Research Institute

Scottsdale, Arizona 85258-4566

United States

University of Arizona Cancer Center

Tucson, Arizona 85724-0001

United States

University of California San Diego (Ucsd) Moores Cancer Center

La Jolla, California 92093-1503

United States

Stanford Medicine

Palo Alto, California 94304-2205

United States

UCLA Santa Monica Cancer Care

Santa Monica, California 90404-2023

United States

Uchealth North

Fort Collins, Colorado 80528-3413

United States

Mayo Clinic Jacksonville

Jacksonville, Florida 32224-1865

United States

Mount Sinai Medical Center Braman Comprehensive Cancer Center

Miami, Florida 33140

United States

Tampa General Hospital Cancer Institute

Tampa, Florida 33606-3571

United States

Augusta University

Augusta, Georgia 30912-0002

United States

Southeastern Regional Medical Center

Newnan, Georgia 30265-8001

United States

Midwestern Regional Medical Center

Zion, Illinois 60099-2676

United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa 52242-1009

United States

Norton Cancer Institute Pavilion

Louisville, Kentucky 40207-4700

United States

Mary Bird Perkins Cancer Center

Baton Rouge, Louisiana 70809-3738

United States

American Oncology Partners of Maryland Pa

Bethesda, Maryland 20817-7847

United States

Dana Farber Cancer Institute

Boston, Massachusetts 02215-5418

United States

Karmanos Cancer Institute

Detroit, Michigan 48201-2013

United States

Mayo Clinic Rochester

Rochester, Minnesota 55905-0001

United States

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada 89169-3321

United States

Roswell Park Comprehensive Cancer Center

Buffalo, New York 14203

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

Tennesse Oncology Chattanooga Downtown

Chattanooga, Tennessee 37404

United States

Tennessee Oncology, Pllc Nashville

Nashville, Tennessee 37203

United States

Md Anderson Cancer Center

Houston, Texas 77030-3907

United States

Virginia Commonwealth University Massey Cancer Center

Richmond, Virginia 23298

United States

Fred Hutchinson Cancer Research Center

Seattle, Washington 98109-4433

United States

Concord Repatriation General Hospital

Concord, New South Wales NSW 2139

Australia

Calvary Mater Newcastle

Waratah, New South Wales NSW 2298

Australia

Princess Alexandra Hospital

Woolloongabba, Queensland QLD 4102

Australia

St Vincents Hospital Melbourne

Fitzroy, Victoria VIC 3065

Australia

Austin Health

Heidelberg, Victoria VIC 3084

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

Perth Blood Institute

West Perth, Western Australia WA 6005

Australia

Hospital Sirio Libanes Brasilia

Brasília, 70200-730

Brazil

Hospital Erasto Gaertner

Curitiba, 81520-060

Brazil

Centro Gaucho Integrado de Oncologia Hospital Mae de Deus

Porto Alegre, 90110-270

Brazil

Real E Benemerita Associacao Portuguesa de Sao Paulo

São Paulo, 01321-001

Brazil

Instituto Dor de Pesquisa E Ensino Sao Paulo

São Paulo, 01401-004

Brazil

Hospital Nove de Julho Dasa

São Paulo, 01409-001

Brazil

Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

São Paulo, 05652-900

Brazil

Arthur Je Child Comprehensive Cancer Centre

Calgary, Alberta T2N 5G2

Canada

Cross Cancer Institute

Edmonton, Alberta T6G 1Z2

Canada

British Columbia Cancer Agency the Vancouver Centre

Vancouver, British Columbia V5Z 4E6

Canada

Princess Margaret Cancer Centre

Toronto, Ontario M5G 2M9

Canada

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

Québec, G1J 1Z4

Canada

Peking Union Medical College Hospital

Beijing, Beijing Municipality 100730

China

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality 630014

China

Fujian Medical University Union Hospital

Fuzhou, Fujian 350001

China

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong 510515

China

Guangxi Medical University Cancer Hospital Wuxiang Branch

Nanning, Guangxi 530201

China

The Fourth Hospital of Hebei Medical University East Branch

Shijiazhuang, Hebei 050035

China

Henan Cancer Hospital

Zhengzhou, Henan 450000

China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan 450052

China

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

Wuhan, Hubei 430022

China

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

Wuhan, Hubei 430030

China

Yichang Central Peoples Hospitaljiangnan Branch

Yichang, Hubei 443001

China

Jiangsu Province Hospital

Nanjing, Jiangsu 210029

China

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu 215006

China

The First Affiliated Hospital of Nanchang University Branch Xianghu

Nanchang, Jiangxi 332000

China

Shengjing Hospital of China Medical Universityshenbei Branch

Shenyang, Liaoning 110134

China

Rui Jin Hospital Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality 200025

China

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality 300060

China

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

Tianjin, Tianjin Municipality 301617

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

Centre de Lutte Contre Le Cancer Institut Bergonie

Bordeaux, 33000

France

Hopital Estaing

ClermontFerrand, 63100

France

Chu Henri Mondor

Créteil, 94000

France

Hopital Claude Huriez Chu Lille

Lille, 59000

France

Centre Leon Berard

Lyon, 69373

France

Institut Paoli Calmettes

Marseille, 13009

France

Chu Montpellier Hopital Saint Eloi

Montpellier, 34090

France

Hopital de La Pitie Salpetriere

Paris, 75013

France

Centre Henri Becquerel

Rouen, 76038

France

Arensia Exploratory Medicine Llc

Tbilisi, 0112

Georgia

Uniklinik Koeln (Aoer)

Cologne, 50937

Germany

Universitatsklinikum Carl Gustav Carus An Der Technischen Universitat Dresden

Dresden, 01307

Germany

Universitares Krebszentrum Leipzig

Leipzig, 04103

Germany

Universitaetsklinikum Schleswig Holstein Campus Luebeck

Lübeck, 23538

Germany

Klinikum Johannes Gutenberg Universitaet Mainz

Mainz, 55131

Germany

Klinikum Grosshadern Ludwig Maximilians Universitat Munchen

München, 81377

Germany

Universitaetsklinikum Ulm

Ulm, 89081

Germany

Policlinico Sorsola Malpighi, Aou Di Bologna

Bologna, 40138

Italy

Ospedale San Raffaele

Milan, 20132

Italy

Istituto Europeo Di Oncologia

Milan, 20141

Italy

Niguarda Cancer Center Division of Hematology

Milan, 20162

Italy

Fondazione Policlinico Universitario Agostino Gemelli

Roma, 00168

Italy

Centroricerche Cliniche Di Verona Srl

Verona, 37134

Italy

Aichi Cancer Center Hospital Clinical Oncology

Nagoya, Aichi-ken 464-8681

Japan

Chiba Cancer Center

Chiba, Chiba 260-8717

Japan

National Cancer Center Hospital East

Kashiwa, Chiba 277-8577

Japan

Cancer Institute Hospital of Jfcr

Kotoku, Tokyo 135-8550

Japan

Yokohama Municipal Citizens Hospital

Yokohama, 221-0855

Japan

The Institute of Oncology, Arensia Exploratory Medicine

Chisinau, 2025

Moldova

Inje University Busan Paik Hospital

BusanjinGu, Busan Gwang'yeogsi 47392

South Korea

Pusan National University Hospital

Seogu, Busan Gwang'yeogsi 49241

South Korea

Samsung Medical Center

GangnamGu, Seoul Teugbyeolsi 06351

South Korea

The Catholic University of Korea, Seoul St Marys Hospital

SeochoGu, Seoul Teugbyeolsi 06591

South Korea

Severance Hospital Yonsei University Health System

SeodaemunGu, Seoul Teugbyeolsi 03722

South Korea

Seoul National University Hospital

Seoul, Seoul Teugbyeolsi 03080

South Korea

Asan Medical Center

SongpaGu, Seoul Teugbyeolsi 05505

South Korea

Hospital Universitario Vall Dhebron

Barcelona, 08035

Spain

Hospital General Universitario Gregorio Maranon

Madrid, 28007

Spain

Md Anderson Cancer Center Madrid Spain

Madrid, 28033

Spain

Hospital Universitario Fundacion Jimenez Diaz

Madrid, 28040

Spain

Hospital Universitario La Paz

Madrid, 28046

Spain

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, 28222

Spain

Hospital Clinico Universitario de Valencia

Valencia, 46010

Spain

Sahlgrenska University Hospital Hematology

Gothenburg, 413 46

Sweden

Karolinska Universitetssjukhuset Solna

Stockholm, 171 76

Sweden

Dokuz Eylul University

Balçova, 35330

Turkey (Türkiye)

Erciyes University

Kayseri, 38030

Turkey (Türkiye)

Sakarya Training and Research Hospital

Sakarya, 54100

Turkey (Türkiye)

Ondokuz Mayis University

Samsun, 55200

Turkey (Türkiye)

Edinburgh Cancer Centre

Edinburgh, EH4 2XU

United Kingdom

St Jamess University Hospital

Leeds, LS9 7TF

United Kingdom

Freeman Hospital

Newcastle upon Tyne, NE7 7DN

United Kingdom

Genesiscare Cambridge

Newmarket, CB8 7XN

United Kingdom

Nottingham University Hospitals Nhs Trust

Nottingham, NG5 1PB

United Kingdom

Derriford Hospital

Plymouth, PL6 8DH

United Kingdom