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A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies
NCT05006716 · BeOne Medicines
In plain English
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Official title
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
About this study
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
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. Measurable disease by radiographic assessment or serum IgM level (WM only)
5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
6. 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.
Study design
Enrollment target: 614 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2021-09-13
Estimated completion: 2029-11
Last updated: 2026-04-15
Interventions
Drug: BGB-16673
Primary outcomes
- • Phase 1: Number of Participants with Adverse Events (AEs) (From the first dose of BGB-16673 until 30 days after the last dose of the study drug or before the initiation of a new anticancer therapy, whichever occurs first (Up to 47 weeks))
- • Phase 1: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BGB-16673 (Approximately 28 days)
- • Phase 1: Recommended dose(s) for Expansion (RDFE) of BGB-16673 (Approximately 3 years)
Sponsor
BeOne Medicines · industry
Contacts & investigators
ContactBeOne Medicines · contact · clinicaltrials@beonemed.com · 1.877.828.5568
ContactStudy Director, MD · contact
InvestigatorStudy Director · study_director, BeOne Medicines
All locations (126)
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Mayo Clinic PhoenixCompleted
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Honor Health Research InstituteRecruiting
Scottsdale, Arizona, United States
University of Arizona Cancer CenterRecruiting
Tucson, Arizona, United States
University of California San Diego (Ucsd) Moores Cancer CenterRecruiting
La Jolla, California, United States
Stanford MedicineRecruiting
Palo Alto, California, United States
UCLA Santa Monica Cancer CareRecruiting
Santa Monica, California, United States
Uchealth NorthRecruiting
Fort Collins, Colorado, United States
Mayo Clinic JacksonvilleRecruiting
Jacksonville, Florida, United States
Mount Sinai Comprehensive Cancer CenterRecruiting
Miami Beach, Florida, United States
Tampa General Hospital Cancer InstituteRecruiting
Tampa, Florida, United States
Augusta UniversityRecruiting
Augusta, Georgia, United States
Southeastern Regional Medical CenterRecruiting
Newnan, Georgia, United States
Midwestern Regional Medical CenterCompleted
Zion, Illinois, United States
University of Iowa Hospitals and ClinicsRecruiting
Iowa City, Iowa, United States
Mary Bird Perkins Cancer CenterRecruiting
Baton Rouge, Louisiana, United States
American Oncology Partners of Maryland PaRecruiting
Bethesda, Maryland, United States
Dana Farber Cancer InstituteRecruiting
Boston, Massachusetts, United States
Karmanos Cancer InstituteRecruiting
Detroit, Michigan, United States
Mayo Clinic RochesterRecruiting
Rochester, Minnesota, United States
Comprehensive Cancer Centers of NevadaRecruiting
Las Vegas, Nevada, United States
Roswell Park Comprehensive Cancer CenterRecruiting
Buffalo, New York, United States
Columbia University Medical CenterRecruiting
New York, New York, United States
Weill Cornell Medical College Newyork Presbyterian HospitalRecruiting
New York, New York, United States
Memorial Sloan Kettering Cancer Center MskccRecruiting
New York, New York, United States
Tennesse Oncology Chattanooga DowntownRecruiting
Chattanooga, Tennessee, United States
Tennessee Oncology, Pllc NashvilleRecruiting
Nashville, Tennessee, United States
Md Anderson Cancer CenterRecruiting
Houston, Texas, United States
Virginia Commonwealth University Massey Cancer CenterRecruiting
Richmond, Virginia, United States
Fred Hutchinson Cancer Research CenterRecruiting
Seattle, Washington, United States
Concord Repatriation General HospitalRecruiting
Concord, New South Wales, Australia
Calvary Mater NewcastleRecruiting
Waratah, New South Wales, Australia
Princess Alexandra HospitalRecruiting
Woolloongabba, Queensland, Australia
St Vincents Hospital MelbourneRecruiting
Fitzroy, Victoria, Australia
Austin HealthRecruiting
Heidelberg, Victoria, Australia
Peter Maccallum Cancer CentreRecruiting
Melbourne, Victoria, Australia
The Alfred HospitalRecruiting
Melbourne, Victoria, Australia
Linear Clinical ResearchRecruiting
Nedlands, Western Australia, Australia
Perth Blood InstituteRecruiting
West Perth, Western Australia, Australia
Hospital Sirio Libanes BrasiliaRecruiting
Brasília, Brazil
Instituto de Pesquisa Em Saude Da Universidade de Caxias Do SulCompleted
Caxias do Sul, Brazil
Hospital Erasto GaertnerRecruiting
Curitiba, Brazil
Centro Gaucho Integrado de Oncologia Hospital Mae de DeusRecruiting
Porto Alegre, Brazil
Hospital Ernesto DornellesCompleted
Porto Alegre, Brazil
Real E Benemerita Associacao Portuguesa de Sao PauloRecruiting
São Paulo, Brazil
Hospital Alemao Oswaldo CruzCompleted
São Paulo, Brazil
Hospital Nove de Julho DasaRecruiting
São Paulo, Brazil
Instituto Dor de Pesquisa E Ensino Sao PauloRecruiting
São Paulo, Brazil
Sociedade Beneficente Israelita Brasileira Hospital Albert EinsteinRecruiting
São Paulo, Brazil
Arthur Je Child Comprehensive Cancer CentreRecruiting
Calgary, Alberta, Canada
Cross Cancer InstituteRecruiting
Edmonton, Alberta, Canada
British Columbia Cancer Agency the Vancouver CentreRecruiting
Vancouver, British Columbia, Canada
Princess Margaret Cancer CentreRecruiting
Toronto, Ontario, Canada
Chu de Quebec Universite Laval, Hopital de Lenfant Jesus, Centre Integre de Cancerologie (Cic)Recruiting
Québec, Canada
Peking Union Medical College HospitalRecruiting
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Chongqing Medical UniversityRecruiting
Chongqing, Chongqing Municipality, China
Fujian Medical University Union HospitalRecruiting
Fuzhou, Fujian, China
Nanfang Hospital, Southern Medical UniversityRecruiting
Guangzhou, Guangdong, China
Guangxi Medical University Cancer Hospital Wuxiang BranchRecruiting
Nanning, Guangxi, China
Henan Cancer HospitalRecruiting
Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou UniversityRecruiting
Zhengzhou, Henan, China
Union Hospital of Tongji Medical College, Huazhong University of Science and TechnologyRecruiting
Wuhan, Hubei, China
Tongji Hospital of Tongji Medical College Huazhong University of Science and TechnologyRecruiting
Wuhan, Hubei, China
Yichang Central Peoples Hospitaljiangnan BranchRecruiting
Yichang, Hubei, China
Jiangsu Province HospitalRecruiting
Nanjing, Jiangsu, China
The First Affiliated Hospital of Soochow UniversityRecruiting
Suzhou, Jiangsu, China
The First Affiliated Hospital of Nanchang University Branch XianghuRecruiting
Nanchang, Jiangxi, China
Rui Jin Hospital Shanghai Jiao Tong University School of MedicineRecruiting
Shanghai, Shanghai Municipality, China
Tianjin Medical University Cancer Institute and HospitalRecruiting
Tianjin, Tianjin Municipality, China
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciencestuanbo BranchRecruiting
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital, Zhejiang University School of MedicinechengzhanRecruiting
Hangzhou, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical UniversityRecruiting
Wenzhou, Zhejiang, China
Centre de Lutte Contre Le Cancer Institut BergonieRecruiting
Bordeaux, France
Hopital EstaingRecruiting
Clermontferrand, France
Chu Henri MondorRecruiting
Créteil, France
Hopital Claude Huriez Chu LilleRecruiting
Lille, France
Centre Leon BerardRecruiting
Lyon, France
Institut Paoli CalmettesRecruiting
Marseille, France
Chu Montpellier Hopital Saint EloiRecruiting
Montpellier, France
Hopital de La Pitie SalpetriereRecruiting
Paris, France
Centre Henri BecquerelRecruiting
Rouen, France
Arensia Exploratory Medicine LlcRecruiting
Tbilisi, Georgia
Uniklinik Koeln (Aoer)Recruiting
Cologne, Germany
Universitatsklinikum Carl Gustav Carus An Der Technischen Universitat DresdenRecruiting
Dresden, Germany
Universitares Krebszentrum LeipzigRecruiting
Leipzig, Germany
Universitaetsklinikum Schleswig Holstein Campus LuebeckRecruiting
Lübeck, Germany
Klinikum Johannes Gutenberg Universitaet MainzRecruiting
Mainz, Germany
Klinikum Grosshadern Ludwig Maximilians Universitat MunchenRecruiting
München, Germany
Universitaetsklinikum UlmRecruiting
Ulm, Germany
Policlinico Sorsola Malpighi, Aou Di BolognaRecruiting
Bologna, Italy
Ospedale San RaffaeleRecruiting
Milan, Italy
Istituto Europeo Di OncologiaRecruiting
Milan, Italy
Niguarda Cancer Center Division of HematologyRecruiting
Milan, Italy
Fondazione Policlinico Universitario Agostino GemelliRecruiting
Roma, Italy
Centroricerche Cliniche Di Verona SrlRecruiting
Verona, Italy
Aichi Cancer Center Hospital Clinical OncologyRecruiting
Nagoya, Aichi-ken, Japan
Chiba Cancer CenterRecruiting
Chiba, Chiba, Japan
National Cancer Center Hospital EastRecruiting
Kashiwa, Chiba, Japan
Cancer Institute Hospital of JfcrRecruiting
Kotoku, Tokyo, Japan
Yokohama Municipal Citizens HospitalRecruiting
Yokohama, Japan
The Institute of Oncology, Arensia Exploratory MedicineActive Not Recruiting
Chisinau, Moldova
Inje University Busan Paik HospitalRecruiting
BusanjinGu, Busan Gwang'yeogsi, South Korea
Pusan National University HospitalRecruiting
Seogu, Busan Gwang'yeogsi, South Korea
Samsung Medical CenterRecruiting
GangnamGu, Seoul Teugbyeolsi, South Korea
The Catholic University of Korea, Seoul St Marys HospitalRecruiting
SeochoGu, Seoul Teugbyeolsi, South Korea
Severance Hospital Yonsei University Health SystemRecruiting
SeodaemunGu, Seoul Teugbyeolsi, South Korea
Seoul National University HospitalRecruiting
Seoul, Seoul Teugbyeolsi, South Korea
Asan Medical CenterRecruiting
SongpaGu, Seoul Teugbyeolsi, South Korea
Hospital Universitario Vall DhebronRecruiting
Barcelona, Spain
Hospital General Universitario Gregorio MaranonRecruiting
Madrid, Spain
Md Anderson Cancer Center Madrid SpainRecruiting
Madrid, Spain
Hospital Universitario Fundacion Jimenez DiazRecruiting
Madrid, Spain
Hospital Universitario La PazRecruiting
Madrid, Spain
Hospital Universitario Puerta de Hierro MajadahondaRecruiting
Majadahonda, Spain
Hospital Clinico Universitario de ValenciaRecruiting
Valencia, Spain
Sahlgrenska University Hospital HematologyRecruiting
Gothenburg, Sweden
Karolinska Universitetssjukhuset SolnaRecruiting
Stockholm, Sweden
Dokuz Eylul UniversityRecruiting
Balçova, Turkey (Türkiye)
Erciyes UniversityRecruiting
Kayseri, Turkey (Türkiye)
Sakarya Training and Research HospitalRecruiting
Sakarya, Turkey (Türkiye)
Ondokuz Mayis UniversityRecruiting
Samsun, Turkey (Türkiye)
Edinburgh Cancer CentreRecruiting
Edinburgh, United Kingdom
St Jamess University HospitalRecruiting
Leeds, United Kingdom
Freeman HospitalRecruiting
Newcastle upon Tyne, United Kingdom
Nottingham University Hospitals Nhs TrustRecruiting
Nottingham, United Kingdom
Derriford HospitalRecruiting
Plymouth, United Kingdom