A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies
NCT ID: NCT05006716
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
614 participants
INTERVENTIONAL
2021-09-13
2029-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Part 1a (Monotherapy Dose Escalation)
Dose escalation in specific subtypes of non-Hodgkin lymphoma (NHL), including relapsed or refractory (R/R) marginal zone lymphoma (MZL), R/R follicular lymphoma (FL) Grades 1, 2, and 3a, R/R mantle cell lymphoma (MCL), R/R chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), R/R diffuse large B-cell lymphoma (DLBCL), R/R Richter's transformation (RT), and R/R Waldenström macroglobulinemia (WM), to evaluate the safety and tolerability of BGB-16673.
BGB-16673
Orally administered
Part 1b (Monotherapy Safety Expansion)
Participants with R/R MZL, MCL, CLL/SLL, and WM will be enrolled at selected doses to help determine the recommended dose(s) for expansion (RDFE(s)) for BGB-16673.
BGB-16673
Orally administered
Part 1c (Additional Monotherapy Safety Expansion)
Additional safety data will be collected from participants with R/R MZL, WM, RT, DLBCL, or FL to confirm the RDFE(s) of BGB-16673 for those with non-CLL/SLL/MCL histologies.
BGB-16673
Orally administered
Part 1d (Additional Monotherapy Safety Expansion in R/R CLL/SLL)
Participants with R/R CLL/SLL will be enrolled at selected RDFE(s) to generate additional safety and efficacy data for BGB-16673.
BGB-16673
Orally administered
Part 1e (Japan-only Cohort)
Japanese participants with R/R MZL, FL, MCL, CLL/SLL, and WM will be enrolled at selected RDFE(s) to assess the safety and tolerability of BGB-16673.
BGB-16673
Orally administered
Part 1f (Additional Monotherapy Safety Expansion in BTKi Naive B-Cell Malignancies)
Participants with CLL/SLL, MCL, WM, MZL, or Richter's transformation to DLBCL who have not received a prior BTKi (either covalent or noncovalent) will be enrolled at selected dose levels.
BGB-16673
Orally administered
Phase 2 (Monotherapy Expansion)
Cohorts of participants with R/R CLL/SLL, R/R MCL, R/R WM, R/R MZL, R/R FL, R/R RT, and R/R DLBCL will be enrolled to receive the RDFE(s) identified in Phase 1 to further evaluate the safety and efficacy of BGB-16673.
BGB-16673
Orally administered
Interventions
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BGB-16673
Orally administered
Eligibility Criteria
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Inclusion Criteria
2. Participants who have previously received a covalently-binding Bruton´s tyrosine kinase (BTK) inhibitor (BTKi) in any line of therapy must have received treatment with the BTK inhibitor for ≥ 8 weeks (unless reason for discontinuation is intolerance).
3. For dose-finding and dose-expansion, participants who had previously received a covalently-binding BTK inhibitor as monotherapy or in combination with other anticancer agents are eligible for the study if they meet any of the following criteria: discontinued the previous BTK inhibitor due to disease progression, experienced disease progression after completing treatment with a BTK inhibitor or discontinued the BTK inhibitor due to toxicity or intolerance.
4. Measurable disease by radiographic assessment or serum IgM level (WM only)
5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
6. Participants enrolling in the dose finding phase of the study may be previously treated with a BTKi or may be naïve to BTKi therapy depending on the diagnosis and country of enrollment; participants with MCL enrolling in the expansion cohorts (Phase 2) must have been treated with a BTKi in a prior line of therapy; CLL/SLL participants, in addition to being treated with a BTKi in a prior line of therapy, must also have received a Bcl-2 inhibitor in a prior line of therapy as well (Phase 2).
Exclusion Criteria
2. Requires ongoing systemic treatment for any other malignancy
3. Requires ongoing systemic (defined as ≥ 10 mg/day of prednisone or equivalent) corticosteroid treatment.
4. Current or history of central nervous system involvement including the brain, spinal cord, leptomeninges, and cerebrospinal fluid (as documented by imaging, cytology, or biopsy) by B-cell malignancy, regardless of whether participants had received treatment for central nervous system disease
5. Known active plasma cell neoplasm, prolymphocytic leukemia, T-cell lymphoma, Burkitt lymphoma, acquired immunodeficiency syndrome (AIDS)-related B-cell lymphoma, Castleman disease, post-transplant lymphoproliferative disorders, hairy cell leukemia, germinal center B-cell (GCB), DLBCL, EBV+ DLBCL NOS, primary DLBCL of the central nervous system (CNS), primary cutaneous DLBCL - leg type, DLBCL associated with chronic inflammation, primary mediastinal (thymic) large B-cell lymphoma, intravascular large B-cell lymphoma, ALK+ large B-cell lymphoma, primary effusion lymphoma, high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements, high-grade B-cell lymphoma - NOS, B-cell lymphoma unclassifiable with features intermediate between DLBCL and classical Hodgkin lymphoma, or history of or currently suspected transformation of an indolent lymphoma to an aggressive histology (except for participants with Richter Transformation to DLBCL are eligible for Part 1a, 1c, or Phase 2 and participants with history of follicular lymphoma transforming to non-GCB DLBCL who are eligible for Part 1a, 1c, or Phase 2).
18 Years
ALL
No
Sponsors
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BeOne Medicines
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
BeOne Medicines
Locations
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University of Alabama At Birmingham Hospital
Birmingham, Alabama, United States
Mayo Clinic Phoenix
Phoenix, Arizona, United States
Honor Health Research Institute
Scottsdale, Arizona, United States
University of Arizona Cancer Center
Tucson, Arizona, United States
University of California San Diego (Ucsd) Moores Cancer Center
La Jolla, California, United States
Stanford Medicine
Palo Alto, California, United States
UCLA Santa Monica Cancer Care
Santa Monica, California, United States
Uchealth North
Fort Collins, Colorado, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, United States
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, United States
Tampa General Hospital Cancer Institute
Tampa, Florida, United States
Augusta University
Augusta, Georgia, United States
Southeastern Regional Medical Center
Newnan, Georgia, United States
Midwestern Regional Medical Center
Zion, Illinois, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Norton Cancer Institute Pavilion
Louisville, Kentucky, United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, United States
American Oncology Partners of Maryland Pa
Bethesda, Maryland, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States
Columbia University Medical Center
New York, New York, United States
Weill Cornell Medical College Newyork Presbyterian Hospital
New York, New York, United States
Memorial Sloan Kettering Cancer Center Mskcc
New York, New York, United States
Tennesse Oncology Chattanooga Downtown
Chattanooga, Tennessee, United States
Tennessee Oncology, Pllc Nashville
Nashville, Tennessee, United States
Md Anderson Cancer Center
Houston, Texas, United States
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Concord Repatriation General Hospital
Concord, New South Wales, Australia
Calvary Mater Newcastle
Waratah, New South Wales, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
St Vincents Hospital Melbourne
Fitzroy, Victoria, Australia
Austin Health
Heidelberg, Victoria, Australia
Peter Maccallum Cancer Centre
Melbourne, Victoria, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Linear Clinical Research
Nedlands, Western Australia, Australia
Perth Blood Institute
West Perth, Western Australia, Australia
Hospital Sirio Libanes Brasilia
Brasília, , Brazil
Hospital Erasto Gaertner
Curitiba, , Brazil
Centro Gaucho Integrado de Oncologia Hospital Mae de Deus
Porto Alegre, , Brazil
Real E Benemerita Associacao Portuguesa de Sao Paulo
São Paulo, , Brazil
Hospital Alemao Oswaldo Cruz
São Paulo, , Brazil
Hospital Nove de Julho Dasa
São Paulo, , Brazil
Instituto Dor de Pesquisa E Ensino Sao Paulo
São Paulo, , Brazil
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
São Paulo, , Brazil
Hospital Santa Rita de Cassia Afecc
Vitória, , Brazil
Arthur Je Child Comprehensive Cancer Centre
Calgary, Alberta, Canada
Cross Cancer Institute
Edmonton, Alberta, Canada
British Columbia Cancer Agency the Vancouver Centre
Vancouver, British Columbia, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Chu de Quebec Universite Laval, Hopital de Lenfant Jesus, Centre Integre de Cancerologie (Cic)
Québec, , Canada
Centre de Lutte Contre Le Cancer Institut Bergonie
Bordeaux, , France
Hopital Estaing
Clermontferrand, , France
Chu Henri Mondor
Créteil, , France
Hopital Claude Huriez Chu Lille
Lille, , France
Centre Leon Berard
Lyon, , France
Institut Paoli Calmettes
Marseille, , France
Chu Montpellier Hopital Saint Eloi
Montpellier, , France
Hopital de La Pitie Salpetriere
Paris, , France
Centre Henri Becquerel
Rouen, , France
Arensia Exploratory Medicine Llc
Tbilisi, , Georgia
Uniklinik Koeln (Aoer)
Cologne, , Germany
Universitatsklinikum Carl Gustav Carus An Der Technischen Universitat Dresden
Dresden, , Germany
Universitares Krebszentrum Leipzig
Leipzig, , Germany
Universitaetsklinikum Schleswig Holstein Campus Luebeck
Lübeck, , Germany
Klinikum Johannes Gutenberg Universitaet Mainz
Mainz, , Germany
Klinikum Grosshadern Ludwig Maximilians Universitat Munchen
München, , Germany
Universitaetsklinikum Ulm
Ulm, , Germany
Policlinico Sorsola Malpighi, Aou Di Bologna
Bologna, , Italy
Ospedale San Raffaele
Milan, , Italy
Istituto Europeo Di Oncologia
Milan, , Italy
Niguarda Cancer Center Division of Hematology
Milan, , Italy
Fondazione Policlinico Universitario Agostino Gemelli
Roma, , Italy
Centroricerche Cliniche Di Verona Srl
Verona, , Italy
Aichi Cancer Center Hospital Clinical Oncology
Nagoya, Aichi-ken, Japan
Chiba Cancer Center
Chiba, Chiba, Japan
Cancer Institute Hospital of Jfcr
Kotoku, Tokyo, Japan
Yokohama Municipal Citizens Hospital
Yokohama, , Japan
The Institute of Oncology, Arensia Exploratory Medicine
Chisinau, , Moldova
Inje University Busan Paik Hospital
BusanjinGu, Busan Gwang'yeogsi, South Korea
Pusan National University Hospital
Seogu, Busan Gwang'yeogsi, South Korea
Samsung Medical Center
GangnamGu, Seoul Teugbyeolsi, South Korea
The Catholic University of Korea, Seoul St Marys Hospital
SeochoGu, Seoul Teugbyeolsi, South Korea
Severance Hospital Yonsei University Health System
SeodaemunGu, Seoul Teugbyeolsi, South Korea
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, South Korea
Asan Medical Center
SongpaGu, Seoul Teugbyeolsi, South Korea
Hospital Universitario Vall Dhebron
Barcelona, , Spain
Hospital General Universitario Gregorio Maranon
Madrid, , Spain
Md Anderson Cancer Center Madrid Spain
Madrid, , Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, , Spain
Hospital Clinico Universitario de Valencia
Valencia, , Spain
Sahlgrenska University Hospital Hematology
Gothenburg, , Sweden
Karolinska Universitetssjukhuset Solna
Stockholm, , Sweden
Dokuz Eylul University
Balçova, , Turkey (Türkiye)
Erciyes University
Kayseri, , Turkey (Türkiye)
Sakarya Training and Research Hospital
Sakarya, , Turkey (Türkiye)
Ondokuz Mayis University
Samsun, , Turkey (Türkiye)
Edinburgh Cancer Centre
Edinburgh, , United Kingdom
Churchill Hospital Oxford University Hospital Nhs Trust
Headington, , United Kingdom
St Jamess University Hospital
Leeds, , United Kingdom
Freeman Hospital
Newcastle upon Tyne, , United Kingdom
Nottingham University Hospitals Nhs Trust
Nottingham, , United Kingdom
Derriford Hospital
Plymouth, , United Kingdom
Countries
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Central Contacts
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Study Director, MD
Role: CONTACT
Other Identifiers
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2022-502157-33-00
Identifier Type: OTHER
Identifier Source: secondary_id
BGB-16673-101
Identifier Type: -
Identifier Source: org_study_id