Actively Recruiting
A Study to Investigate Safety and Effectiveness of BGB-16673 in Combination With Other Agents in Participants With Relapsed or Refractory B-Cell Malignancies
Led by BeOne Medicines · Updated on 2026-05-11
80
Participants Needed
50
Research Sites
261 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Investigate Safety and Effectiveness of BGB-16673 in Combination With Other Agents in Participants With Relapsed or Refractory B-Cell Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must sign the informed consent form and be able to comply with study requirements
- Confirmed diagnosis of relapsed or refractory B-cell malignancy
- Measurable disease as defined by the study protocol
- Stable Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Adequate organ function
- Female participants of childbearing potential must use effective birth control and have negative pregnancy tests before treatment
- Nonsterile male participants must use effective birth control and avoid sperm donation during the study and specified periods after treatment
- Substudies 1, 3, and 4: Adequate kidney function with estimated glomerular filtration rate (eGFR) of at least 50 mL/min
- Substudy 2: BTK inhibitor-naive or previously treated with covalent BTK inhibitor but discontinued for reasons other than progression
- Substudy 2: Adequate kidney function with eGFR of at least 30 mL/min
You will not qualify if you...
- Treatment-naive B-cell malignancies
- Unable to comply with study protocol requirements
- Active leptomeningeal disease or uncontrolled brain metastases
- Any malignancy within 2 years before the first dose except the study cancer or locally recurring cancer treated curatively
- Autologous stem cell transplant or CAR T-cell therapy within 3 months before screening
- Prior invasive fungal infection unless agreeing to secondary antifungal prophylaxis
- Substudies 1 and 2: Prior allogeneic stem cell transplant with active graft-versus-host disease or recent immunosuppressive therapy
- History of severe allergic reactions to study drugs or their components
- Substudy 1: Prior treatment with Bcl-2 inhibitors unless relapse occurred 24 months or more after prior treatment
- Substudy 2: Prior zanubrutinib treatment discontinued due to intolerance
- Substudies 3 and 4: Prior treatment with CD20 x CD3 T-cell engager antibodies
- All participants in substudies 3 and 4 with prior allogeneic stem cell transplant
- Known contraindications or hypersensitivity to azole antifungal agents
- Other protocol-defined criteria may apply
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 50 locations
1
Mayo Clinic Phoenix
Phoenix, Arizona, United States, 85054-4502
Actively Recruiting
2
University of Southern California Norris Comprehensive
Los Angeles, California, United States, 90033
Actively Recruiting
3
Mayo Clinic Jacksonville
Jacksonville, Florida, United States, 32224-1865
Actively Recruiting
4
Moffitt Cancer Center
Tampa, Florida, United States, 33612-9496
Actively Recruiting
5
The University of Kansas Cancer Center
Westwood, Kansas, United States, 66205-2003
Actively Recruiting
6
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905-0001
Actively Recruiting
7
Washington University School of Medicine
St Louis, Missouri, United States, 63110-1010
Actively Recruiting
8
Summit Medical Group
Florham Park, New Jersey, United States, 07932-1049
Actively Recruiting
9
Icahn School of Medicine At Mount Sinai
New York, New York, United States, 10029-6504
Actively Recruiting
10
Columbia University Medical Center
New York, New York, United States, 10032
Actively Recruiting
11
Weill Cornell Medical College Newyork Presbyterian Hospital
New York, New York, United States, 10065-4870
Actively Recruiting
12
Memorial Sloan Kettering Cancer Center Mskcc
New York, New York, United States, 10065-6800
Actively Recruiting
13
University of Rochester
Rochester, New York, United States, 14642-0001
Actively Recruiting
14
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111-2434
Actively Recruiting
15
The University of Texas Md Anderson Cancer Center
Houston, Texas, United States, 77030-4009
Actively Recruiting
16
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112-5550
Actively Recruiting
17
University of Wisconsin
Madison, Wisconsin, United States, 53792-0001
Actively Recruiting
18
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226-1222
Actively Recruiting
19
St George Hospital
Kogarah, New South Wales, Australia, NSW 2217
Actively Recruiting
20
Mater Cancer Care Centre
South Brisbane, Queensland, Australia, QLD 4101
Actively Recruiting
21
Monash Health
Clayton, Victoria, Australia, VIC 3168
Actively Recruiting
22
Peter Maccallum Cancer Centre
Melbourne, Victoria, Australia, VIC 3000
Actively Recruiting
23
The Alfred Hospital
Melbourne, Victoria, Australia, VIC 3004
Actively Recruiting
24
Linear Clinical Research
Nedlands, Western Australia, Australia, WA 6009
Actively Recruiting
25
Hospital Sirio Libanes Brasilia
Brasília, Brazil, 70200-730
Actively Recruiting
26
Ensino E Terapia de Inovacao Clinica Amo Etica
Salvador, Brazil, 41950-640
Actively Recruiting
27
Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto
São José do Rio Preto, Brazil, 15090-000
Actively Recruiting
28
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
São Paulo, Brazil, 05652-900
Actively Recruiting
29
Fujian Medical University Union Hospital
Fuzhou, Fujian, China, 350001
Actively Recruiting
30
Sun Yat Sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
31
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215006
Actively Recruiting
32
The First Affiliated Hospital, Zhejiang University School of Medicinechengzhan
Hangzhou, Zhejiang, China, 310002
Actively Recruiting
33
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China, 325000
Actively Recruiting
34
Universitatsklinikum Carl Gustav Carus An Der Technischen Universitat Dresden
Dresden, Germany, 01307
Actively Recruiting
35
Universitatsklinikum Jena Klinik Fur Innere Medizin Ii
Jena, Germany, 07747
Actively Recruiting
36
Universitatsklinikum Schleswig Holstein, Campus Kiel
Kiel, Germany, 24105
Actively Recruiting
37
Medizinische Universitaetsklinik
Tübingen, Germany, 72076
Actively Recruiting
38
Universitaetsklinikum Ulm
Ulm, Germany, 89081
Actively Recruiting
39
Azienda Ospedaliera Universitaria Policlinico Santorsola Malpighi
Bologna, Italy, 40138
Actively Recruiting
40
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
Milan, Italy, 20162
Actively Recruiting
41
Istituto Nazionale Tumori Fondazione G Pascale
Naples, Italy, 80131
Actively Recruiting
42
Istituto Clinico Humanitas
Rozzano, Italy, 20089
Actively Recruiting
43
Centroricerche Cliniche Di Verona Srl
Verona, Italy, 37134
Actively Recruiting
44
North Shore Hospital
Auckland, New Zealand, 0622
Actively Recruiting
45
Auckland City Hospital
Auckland, New Zealand, 1023
Actively Recruiting
46
Uniwersyteckie Centrum Kliniczne
Gdansk, Poland, 80-214
Actively Recruiting
47
Uniwersytecki Szpital Kliniczny Nr 1 W Lublinie
Lublin, Poland, 20-081
Actively Recruiting
48
Szpital Kliniczny Mswia Z Warmisko Mazurskim Centrum Onkologii
Olsztyn, Poland, 10-228
Actively Recruiting
49
Szpital Wojewodzki W Opolu Sp Z Oo Oddzia Hematologii I Onkologii Hematologicznej
Opole, Poland, 45-061
Actively Recruiting
50
Narodowy Instytut Onkologii Im Marii Sklodowskiej Curie Hematology Unit
Warsaw, Poland, 02-781
Actively Recruiting
Research Team
S
Study Director
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
8
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