Actively Recruiting
A Phase 1b/2 Open-Label Master Protocol Study of BTK-Degrader BGB-16673 in Combination With Other Agents in Patients With Relapsed or Refractory B-Cell Malignancies
Led by BeOne Medicines · Updated on 2026-06-03
80
Participants Needed
50
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the safety, early antitumor effects, and how the body processes and responds to BGB-16673 combined with other medicines in adults with relapsed or refractory B-cell malignancies. This master protocol includes four substudies, each testing BGB-16673 with a different drug: sonrotoclax, zanubrutinib, mosunetuzumab, and glofitamab, with potential to add more combinations in the future. The study is sponsored by BeOne Medicines and focuses on patients with measurable disease and stable health status. Participants receive BGB-16673 orally in combination with one of the other study drugs: sonrotoclax or zanubrutinib (both oral), mosunetuzumab (subcutaneous), or glofitamab (intravenous). Some groups receive increasing doses to find safe levels, while others receive selected doses. In the glofitamab group, obinutuzumab is given beforehand intravenously. Each substudy has two parts: dose escalation and safety expansion, evaluating different dose combinations. During the study, participants are monitored closely for side effects, including dose-limiting toxicities and other adverse events for up to about two years after the last dose. Researchers assess treatment response over approximately three years and measure drug levels in the blood at various time points. Participants undergo regular evaluations, including lab tests and follow-up visits, to track safety and treatment effects throughout the study period.
CONDITIONS
Brief 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 informed consent and comply with study requirements
- Confirmed diagnosis of relapsed or refractory B-cell malignancy
- Measurable disease as defined by the protocol
- Stable ECOG Performance Status of 0 to 2
- Adequate organ function
- Female participants of childbearing potential must use effective birth control and have a negative pregnancy test before treatment
- Nonsterile male participants must use effective birth control
- Substudies 1, 3, and 4: Adequate renal function with eGFR ≥ 50 mL/min
- Substudy 2: BTK inhibitor-naive or discontinued prior covalent BTK inhibitor for reasons other than progression
- Substudy 2: Adequate renal function with eGFR ≥ 30 mL/min
You will not qualify if you...
- Treatment-naive B-cell malignancies
- Unable to comply with study requirements
- Active leptomeningeal disease or uncontrolled brain metastasis
- Any malignancy within 2 years before treatment except the study cancer or curatively treated local recurrence
- Autologous stem cell transplant or chimeric antigen T-cell therapy within 3 months before screening
- Prior invasive fungal infection without agreed secondary antifungal prophylaxis
- Substudies 1 and 2: Prior allogeneic stem cell transplant with active graft-versus-host disease or recent immunosuppressive use
- History of severe allergic reactions to study drugs or their components
- Substudy 1: Prior Bcl-2 inhibitor treatment unless relapse was ≥ 24 months after completion
- Substudy 2: Prior zanubrutinib discontinuation due to intolerance
- Substudies 3 and 4: Prior exposure to CD20 x CD3 T-cell engager antibody
- Substudies 3 and 4: Prior allogeneic stem cell transplant
- Substudies 3 and 4: Contraindications or hypersensitivity to azole antifungal agents
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 2 years
Participants receive oral and injectable study drugs in combination with other agents as per their assigned substudy. This includes dose escalation and safety expansion phases, where participants are given BGB-16673 with sonrotoclax, zanubrutinib, mosunetuzumab, or glofitamab along with pretreatment when applicable.
Regular visits during treatment for drug administration and monitoring
Duration - 30 days after the last dose; up to approximately 3 years for response monitoring
Participants are monitored for safety and treatment effectiveness after the last dose of study drug, including assessment of adverse events and treatment response.
Periodic visits for safety and response assessments
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
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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