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ACTIVE NOT RECRUITING
NCT04277637
PHASE1

Study of Bcl-2 Inhibitor Sonrotoclax (BGB-11417) in Participants With Mature B-Cell Malignancies

Sponsor: BeOne Medicines

View on ClinicalTrials.gov

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

Interventions

DRUG

Sonrotoclax

Film-coated tablets administered once daily at a dose as specified in the treatment arm

DRUG

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)

DRUG

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