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Study of Bcl-2 Inhibitor Sonrotoclax (BGB-11417) in Participants With Mature B-Cell Malignancies
Sponsor: BeOne Medicines
Summary
The purpose of this study is to determine the safety, tolerability; and to define the maximum tolerated dose (MTD) and Recommended Phase 2 Dose (RP2D); and to evaluate the safety and tolerability of the ramp-up dosing schedule and at the RP2D of BGB-11417 monotherapy, and when given in combination with zanubrutinib and obinutuzumab.
Official title: A Phase 1a/1b Open-Label Dose Escalation and Expansion Study of Bcl-2 Inhibitor BGB-11417 in Patients With Mature B-Cell Malignancies
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
437
Start Date
2020-03-24
Completion Date
2027-05-31
Last Updated
2026-03-27
Healthy Volunteers
No
Conditions
Interventions
Sonrotoclax
Film-coated tablets administered once daily at a dose as specified in the treatment arm
Zanubrutinib
320 mg daily administered as two 80-mg capsules twice a day (160 mg twice a day) or as four 80-mg capsules once a day (320 mg once a day)
Obinutuzumab
Given as an intravenous infusion administered per label.
Locations (43)
UCLA Hematologyoncology
Los Angeles, California, United States
Northwestern University
Chicago, Illinois, United States
University of Kansas Medical Center Research Institute
Kansas City, Kansas, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
John Theurer Cancer Center Hackensack University Medical Center
Hackensack, New Jersey, United States
Columbia University Medical Center
New York, New York, United States
Memorial Sloan Kettering Cancer Center Mskcc
New York, New York, United States
The James Cancer Hospital and Solove Research Institute At Ohio State University
Columbus, Ohio, United States
Upmc Hillman Cancer Center(Univ of Pittsburgh)
Pittsburgh, Pennsylvania, United States
Md Anderson Cancer Center
Houston, Texas, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Concord Repatriation General Hospital
Concord, New South Wales, Australia
Orange Health Service (Central West Cancer Care Centre)
Orange, New South Wales, Australia
Pindara Private Hospital
Benowa, Queensland, Australia
John Flynn Private Hospital
Tugun, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Flinders Medical Centre
Bedford PK, South Australia, Australia
Box Hill Hospital
Box Hill, Victoria, Australia
Monash Health
Clayton, Victoria, Australia
St Vincents Hospital Melbourne
Fitzroy, Victoria, Australia
Peter Maccallum Cancer Centre
Melbourne, Victoria, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Linear Clinical Research
Nedlands, Western Australia, Australia
Universitatsklinikum Carl Gustav Carus An Der Technischen Universitat Dresden
Dresden, Germany
Ospedale San Raffaele
Milan, Italy
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
Milan, Italy
Ospedale Santa Maria Della Misericordia
Perugia, Italy
Azienda Unita Sanitaria Locale Di Ravenna
Ravenna, Italy
Fondazione Policlinico Universitario Agostino Gemelli
Roma, Italy
Centroricerche Cliniche Di Verona Srl
Verona, Italy
North Shore Hospital
Auckland, New Zealand
Auckland City Hospital
Auckland, New Zealand
Wellington Regional Hospital (Ccdhb)
Wellington, New Zealand
Vall D Hebron Institute of Oncology Vhio
Barcelona, Spain
Hospital Clinic de Barcelona
Barcelona, Spain
Hospital de La Santa Creu I Sant Pau
Barcelona, Spain
Ico H Duran I Reynals
Barcelona, Spain
Start Madrid Fundacion Jimenez Diaz
Madrid, Spain
Hospital Universitario de Salamanca
Salamanca, Spain
Hospital Universitario Marques de Valdecilla
Santander, Spain
The Leeds Teaching Hospitals Nhs Trust
Leeds, United Kingdom