Actively Recruiting
A Phase 1/2, Open-Label, Dose-Escalation and Expansion Study of BGB-16673, a Bruton Tyrosine Kinase Targeted Protein Degrader, in Patients With B-Cell Malignancies
Led by BeOne Medicines · Updated on 2026-06-03
645
Participants Needed
130
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating BGB-16673, an orally administered Bruton Tyrosine Kinase targeted protein degrader, in adults with various B-cell malignancies including relapsed or refractory forms of marginal zone lymphoma, follicular lymphoma, mantle cell lymphoma, chronic lymphocytic leukemia/small lymphocytic lymphoma, Waldenstr f6m macroglobulinemia, diffuse large B-cell lymphoma, and Richter's transformation. The study aims to find the recommended dose and assess the safety, tolerability, and response rates in this population through a phase 1/2 open-label trial. The trial includes several parts: a phase 1 monotherapy dose finding with dose escalation and safety expansion, followed by phase 2 expansion cohorts. Participants receive BGB-16673 orally at various dose levels to determine the maximum tolerated dose and the recommended dose for further study. Specific groups include Japanese participants and those who have not previously received a Bruton Tyrosine Kinase inhibitor. Dose escalation and safety data are collected to guide dosing recommendations, with some cohorts focused on particular lymphoma subtypes and treatment histories. Participants will be monitored from the first dose of BGB-16673 until 30 days after the last dose or before starting new anticancer therapies, for up to 47 weeks in phase 1 and approximately three years in phase 2. Assessments include adverse event tracking, response rates, pharmacokinetics, and quality of life questionnaires. Various measures such as plasma drug concentration, protein degradation, and progression-free survival are evaluated periodically. Safety and efficacy data support long-term monitoring and dose adjustments throughout the study period.
CONDITIONS
Brief Title
A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Confirmed diagnosis of Marginal Zone Lymphoma, relapsed or refractory Follicular Lymphoma, Mantle Cell Lymphoma, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, Waldenstr�f6m Macroglobulinemia, relapsed or refractory Diffuse Large B-Cell Lymphoma, or Richter's transformation to DLBCL
- Previous treatment with a covalent Bruton Tyrosine Kinase inhibitor for at least 8 weeks unless discontinued due to intolerance
- For Phase 2, participants with CLL/SLL must also have received a Bcl-2 inhibitor in prior therapy
- Measurable disease by radiographic assessment or serum IgM level (for Waldenstr�f6m Macroglobulinemia)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
You will not qualify if you...
- Prior malignancy within the past 2 years except certain in situ or localized cancers with no active disease
- Ongoing systemic treatment for any other malignancy
- Ongoing systemic corticosteroid treatment equivalent to 10 mg/day or more of prednisone
- Current or history of central nervous system involvement by B-cell malignancy
- Presence of specific other B-cell or T-cell lymphomas and related disorders as specified
- History or suspicion of transformation of indolent lymphoma to aggressive histology except for specified eligible cases
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 47 weeks
Participants receive oral BGB-16673 as part of dose escalation and expansion to evaluate safety, tolerability, and efficacy for B-cell malignancies.
Repeated visits during treatment phase
Duration - Approximately 3 years
Participants are monitored for safety and treatment response after completing BGB-16673 treatment.
Periodic visits for long-term monitoring
Trial Site Locations
Total: 130 locations
1
University of Alabama At Birmingham Hospital
Birmingham, Alabama, United States, 35294-0004
Actively Recruiting
2
Mayo Clinic Phoenix
Phoenix, Arizona, United States, 85054-4502
Completed
3
Honor Health Research Institute
Scottsdale, Arizona, United States, 85258-4566
Actively Recruiting
4
University of Arizona Cancer Center
Tucson, Arizona, United States, 85724-0001
Actively Recruiting
5
University of California San Diego (Ucsd) Moores Cancer Center
La Jolla, California, United States, 92093-1503
Actively Recruiting
6
Stanford Medicine
Palo Alto, California, United States, 94304-2205
Actively Recruiting
7
UCLA Santa Monica Cancer Care
Santa Monica, California, United States, 90404-2023
Actively Recruiting
8
Uchealth North
Fort Collins, Colorado, United States, 80528-3413
Actively Recruiting
9
Mayo Clinic Jacksonville
Jacksonville, Florida, United States, 32224-1865
Actively Recruiting
10
Mount Sinai Medical Center Braman Comprehensive Cancer Center
Miami, Florida, United States, 33140
Actively Recruiting
11
Tampa General Hospital Cancer Institute
Tampa, Florida, United States, 33606-3571
Actively Recruiting
12
Augusta University
Augusta, Georgia, United States, 30912-0002
Actively Recruiting
13
Southeastern Regional Medical Center
Newnan, Georgia, United States, 30265-8001
Actively Recruiting
14
Midwestern Regional Medical Center
Zion, Illinois, United States, 60099-2676
Completed
15
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242-1009
Actively Recruiting
16
Norton Cancer Institute Pavilion
Louisville, Kentucky, United States, 40207-4700
Active, Not Recruiting
17
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, United States, 70809-3738
Actively Recruiting
18
American Oncology Partners of Maryland Pa
Bethesda, Maryland, United States, 20817-7847
Actively Recruiting
19
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215-5418
Actively Recruiting
20
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-2013
Actively Recruiting
21
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905-0001
Actively Recruiting
22
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States, 89169-3321
Actively Recruiting
23
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States, 14203
Actively Recruiting
24
Columbia University Medical Center
New York, New York, United States, 10032
Actively Recruiting
25
Weill Cornell Medical College Newyork Presbyterian Hospital
New York, New York, United States, 10065-4870
Actively Recruiting
26
Memorial Sloan Kettering Cancer Center Mskcc
New York, New York, United States, 10065-6800
Actively Recruiting
27
Tennesse Oncology Chattanooga Downtown
Chattanooga, Tennessee, United States, 37404
Actively Recruiting
28
Tennessee Oncology, Pllc Nashville
Nashville, Tennessee, United States, 37203
Actively Recruiting
29
Md Anderson Cancer Center
Houston, Texas, United States, 77030-3907
Actively Recruiting
30
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, United States, 23298
Actively Recruiting
31
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-4433
Actively Recruiting
32
Concord Repatriation General Hospital
Concord, New South Wales, Australia, NSW 2139
Actively Recruiting
33
Calvary Mater Newcastle
Waratah, New South Wales, Australia, NSW 2298
Actively Recruiting
34
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, QLD 4102
Actively Recruiting
35
St Vincents Hospital Melbourne
Fitzroy, Victoria, Australia, VIC 3065
Actively Recruiting
36
Austin Health
Heidelberg, Victoria, Australia, VIC 3084
Actively Recruiting
37
Peter Maccallum Cancer Centre
Melbourne, Victoria, Australia, VIC 3000
Actively Recruiting
38
The Alfred Hospital
Melbourne, Victoria, Australia, VIC 3004
Actively Recruiting
39
Linear Clinical Research
Nedlands, Western Australia, Australia, WA 6009
Actively Recruiting
40
Perth Blood Institute
West Perth, Western Australia, Australia, WA 6005
Actively Recruiting
41
Hospital Sirio Libanes Brasilia
Brasília, Brazil, 70200-730
Actively Recruiting
42
Instituto de Pesquisa Em Saude Da Universidade de Caxias Do Sul
Caxias do Sul, Brazil, 95070-560
Completed
43
Hospital Erasto Gaertner
Curitiba, Brazil, 81520-060
Actively Recruiting
44
Centro Gaucho Integrado de Oncologia Hospital Mae de Deus
Porto Alegre, Brazil, 90110-270
Actively Recruiting
45
Hospital Ernesto Dornelles
Porto Alegre, Brazil, 90160-093
Completed
46
Real E Benemerita Associacao Portuguesa de Sao Paulo
São Paulo, Brazil, 01321-001
Actively Recruiting
47
Hospital Alemao Oswaldo Cruz
São Paulo, Brazil, 01327-001
Completed
48
Instituto Dor de Pesquisa E Ensino Sao Paulo
São Paulo, Brazil, 01401-004
Actively Recruiting
49
Hospital Nove de Julho Dasa
São Paulo, Brazil, 01409-001
Actively Recruiting
50
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
São Paulo, Brazil, 05652-900
Actively Recruiting
51
Arthur Je Child Comprehensive Cancer Centre
Calgary, Alberta, Canada, T2N 5G2
Actively Recruiting
52
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Actively Recruiting
53
British Columbia Cancer Agency the Vancouver Centre
Vancouver, British Columbia, Canada, V5Z 4E6
Actively Recruiting
54
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
55
Chu de Quebec Universite Laval, Hopital de Lenfant Jesus, Centre Integre de Cancerologie (Cic)
Québec, Canada, G1J 1Z4
Actively Recruiting
56
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
57
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China, 630014
Actively Recruiting
58
Fujian Medical University Union Hospital
Fuzhou, Fujian, China, 350001
Actively Recruiting
59
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China, 510515
Actively Recruiting
60
Guangxi Medical University Cancer Hospital Wuxiang Branch
Nanning, Guangxi, China, 530201
Actively Recruiting
61
The Fourth Hospital of Hebei Medical University East Branch
Shijiazhuang, Hebei, China, 050035
Actively Recruiting
62
Henan Cancer Hospital
Zhengzhou, Henan, China, 450000
Actively Recruiting
63
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450052
Actively Recruiting
64
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022
Actively Recruiting
65
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China, 430030
Actively Recruiting
66
Yichang Central Peoples Hospitaljiangnan Branch
Yichang, Hubei, China, 443001
Actively Recruiting
67
Jiangsu Province Hospital
Nanjing, Jiangsu, China, 210029
Actively Recruiting
68
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215006
Actively Recruiting
69
The First Affiliated Hospital of Nanchang University Branch Xianghu
Nanchang, Jiangxi, China, 332000
Actively Recruiting
70
Shengjing Hospital of China Medical Universityshenbei Branch
Shenyang, Liaoning, China, 110134
Actively Recruiting
71
Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200025
Actively Recruiting
72
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China, 300060
Actively Recruiting
73
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciencestuanbo Branch
Tianjin, Tianjin Municipality, China, 301617
Actively Recruiting
74
The First Affiliated Hospital, Zhejiang University School of Medicinechengzhan
Hangzhou, Zhejiang, China, 310002
Actively Recruiting
75
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China, 325000
Actively Recruiting
76
Centre de Lutte Contre Le Cancer Institut Bergonie
Bordeaux, France, 33000
Actively Recruiting
77
Hopital Estaing
ClermontFerrand, France, 63100
Actively Recruiting
78
Chu Henri Mondor
Créteil, France, 94000
Actively Recruiting
79
Hopital Claude Huriez Chu Lille
Lille, France, 59000
Actively Recruiting
80
Centre Leon Berard
Lyon, France, 69373
Actively Recruiting
81
Institut Paoli Calmettes
Marseille, France, 13009
Actively Recruiting
82
Chu Montpellier Hopital Saint Eloi
Montpellier, France, 34090
Actively Recruiting
83
Hopital de La Pitie Salpetriere
Paris, France, 75013
Actively Recruiting
84
Centre Henri Becquerel
Rouen, France, 76038
Actively Recruiting
85
Arensia Exploratory Medicine Llc
Tbilisi, Georgia, 0112
Actively Recruiting
86
Uniklinik Koeln (Aoer)
Cologne, Germany, 50937
Actively Recruiting
87
Universitatsklinikum Carl Gustav Carus An Der Technischen Universitat Dresden
Dresden, Germany, 01307
Actively Recruiting
88
Universitares Krebszentrum Leipzig
Leipzig, Germany, 04103
Actively Recruiting
89
Universitaetsklinikum Schleswig Holstein Campus Luebeck
Lübeck, Germany, 23538
Actively Recruiting
90
Klinikum Johannes Gutenberg Universitaet Mainz
Mainz, Germany, 55131
Actively Recruiting
91
Klinikum Grosshadern Ludwig Maximilians Universitat Munchen
München, Germany, 81377
Actively Recruiting
92
Universitaetsklinikum Ulm
Ulm, Germany, 89081
Actively Recruiting
93
Policlinico Sorsola Malpighi, Aou Di Bologna
Bologna, Italy, 40138
Actively Recruiting
94
Ospedale San Raffaele
Milan, Italy, 20132
Actively Recruiting
95
Istituto Europeo Di Oncologia
Milan, Italy, 20141
Actively Recruiting
96
Niguarda Cancer Center Division of Hematology
Milan, Italy, 20162
Actively Recruiting
97
Fondazione Policlinico Universitario Agostino Gemelli
Roma, Italy, 00168
Actively Recruiting
98
Centroricerche Cliniche Di Verona Srl
Verona, Italy, 37134
Actively Recruiting
99
Aichi Cancer Center Hospital Clinical Oncology
Nagoya, Aichi-ken, Japan, 464-8681
Actively Recruiting
100
Chiba Cancer Center
Chiba, Chiba, Japan, 260-8717
Actively Recruiting
101
National Cancer Center Hospital East
Kashiwa, Chiba, Japan, 277-8577
Actively Recruiting
102
Cancer Institute Hospital of Jfcr
Kotoku, Tokyo, Japan, 135-8550
Actively Recruiting
103
Yokohama Municipal Citizens Hospital
Yokohama, Japan, 221-0855
Actively Recruiting
104
The Institute of Oncology, Arensia Exploratory Medicine
Chisinau, Moldova, 2025
Active, Not Recruiting
105
Inje University Busan Paik Hospital
BusanjinGu, Busan Gwang'yeogsi, South Korea, 47392
Actively Recruiting
106
Pusan National University Hospital
Seogu, Busan Gwang'yeogsi, South Korea, 49241
Actively Recruiting
107
Samsung Medical Center
GangnamGu, Seoul Teugbyeolsi, South Korea, 06351
Actively Recruiting
108
The Catholic University of Korea, Seoul St Marys Hospital
SeochoGu, Seoul Teugbyeolsi, South Korea, 06591
Actively Recruiting
109
Severance Hospital Yonsei University Health System
SeodaemunGu, Seoul Teugbyeolsi, South Korea, 03722
Actively Recruiting
110
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, South Korea, 03080
Actively Recruiting
111
Asan Medical Center
SongpaGu, Seoul Teugbyeolsi, South Korea, 05505
Actively Recruiting
112
Hospital Universitario Vall Dhebron
Barcelona, Spain, 08035
Actively Recruiting
113
Hospital General Universitario Gregorio Maranon
Madrid, Spain, 28007
Actively Recruiting
114
Md Anderson Cancer Center Madrid Spain
Madrid, Spain, 28033
Actively Recruiting
115
Hospital Universitario Fundacion Jimenez Diaz
Madrid, Spain, 28040
Actively Recruiting
116
Hospital Universitario La Paz
Madrid, Spain, 28046
Actively Recruiting
117
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Spain, 28222
Actively Recruiting
118
Hospital Clinico Universitario de Valencia
Valencia, Spain, 46010
Actively Recruiting
119
Sahlgrenska University Hospital Hematology
Gothenburg, Sweden, 413 46
Actively Recruiting
120
Karolinska Universitetssjukhuset Solna
Stockholm, Sweden, 171 76
Actively Recruiting
121
Dokuz Eylul University
Balçova, Turkey (Türkiye), 35330
Actively Recruiting
122
Erciyes University
Kayseri, Turkey (Türkiye), 38030
Actively Recruiting
123
Sakarya Training and Research Hospital
Sakarya, Turkey (Türkiye), 54100
Actively Recruiting
124
Ondokuz Mayis University
Samsun, Turkey (Türkiye), 55200
Actively Recruiting
125
Edinburgh Cancer Centre
Edinburgh, United Kingdom, EH4 2XU
Actively Recruiting
126
St Jamess University Hospital
Leeds, United Kingdom, LS9 7TF
Actively Recruiting
127
Freeman Hospital
Newcastle upon Tyne, United Kingdom, NE7 7DN
Actively Recruiting
128
Genesiscare Cambridge
Newmarket, United Kingdom, CB8 7XN
Actively Recruiting
129
Nottingham University Hospitals Nhs Trust
Nottingham, United Kingdom, NG5 1PB
Actively Recruiting
130
Derriford Hospital
Plymouth, United Kingdom, PL6 8DH
Actively Recruiting
Research Team
B
BeOne Medicines
S
Study Director, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
7
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