A Phase 1/2, Open-Label, Dose-Escalation and -Expansion Study of the Bruton Tyrosine Kinase Targeted Protein Degrader BGB-16673 in Patients With B-Cell Malignancies

Status: Recruiting
Location: See all (115) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

Study consists of two main parts to explore BGB-16673 recommended dosing, a Phase 1 monotherapy dose finding comprised of monotherapy dose escalation and monotherapy safety expansion of selected doses, and a Phase 2 (expansion cohorts)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Confirmed diagnosis (per World Health Organization (WHO) guidelines, unless otherwise noted) of one of the following: Marginal Zone Lymphoma (MZL), R/R follicular lymphoma (FL), mantle cell lymphoma (MCL), chronic lymphocytic leukemia and small lymphocytic lymphoma (CLL/SLL), Waldenström macroglobulinemia (WM), R/R diffuse large B-cell lymphoma (DLBCL), or Richter's transformation to DLBCL.

• 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).

• 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.

• Measurable disease by radiographic assessment or serum IgM level (WM only)

• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2

• 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).

Locations
United States
Alabama
University of Alabama At Birmingham Hospital
RECRUITING
Birmingham
Arizona
Western Regional Medical Center, Llc
RECRUITING
Goodyear
Mayo Clinic Phoenix
RECRUITING
Phoenix
Honor Health Research Institute
RECRUITING
Scottsdale
University of Arizona Cancer Center
RECRUITING
Tucson
California
University of California San Diego (Ucsd) Moores Cancer Center
RECRUITING
La Jolla
Stanford Medicine
RECRUITING
Palo Alto
UCLA Santa Monica Cancer Care
RECRUITING
Santa Monica
Colorado
Uchealth North
RECRUITING
Fort Collins
Florida
Mayo Clinic Jacksonville
RECRUITING
Jacksonville
Mount Sinai Comprehensive Cancer Center
RECRUITING
Miami Beach
Tampa General Hospital Cancer Institute
RECRUITING
Tampa
Georgia
Augusta University
RECRUITING
Augusta
Southeastern Regional Medical Center
RECRUITING
Newnan
Iowa
University of Iowa Hospitals and Clinics
RECRUITING
Iowa City
Illinois
Midwestern Regional Medical Center
RECRUITING
Zion
Kentucky
Norton Cancer Institute Pavilion
COMPLETED
Louisville
Louisiana
Mary Bird Perkins Cancer Center
RECRUITING
Baton Rouge
Massachusetts
Dana Farber Cancer Institute
RECRUITING
Boston
Maryland
American Oncology Partners of Maryland Pa
RECRUITING
Bethesda
Michigan
Karmanos Cancer Institute
RECRUITING
Detroit
Minnesota
Mayo Clinic Rochester
RECRUITING
Rochester
Nevada
Comprehensive Cancer Centers of Nevada
RECRUITING
Las Vegas
New York
Roswell Park Comprehensive Cancer Center
RECRUITING
Buffalo
Columbia University Medical Center
RECRUITING
New York
Memorial Sloan Kettering Cancer Center Mskcc
RECRUITING
New York
Weill Cornell Medical College Newyork Presbyterian Hospital
RECRUITING
New York
Tennessee
Tennesse Oncology Chattanooga Downtown
RECRUITING
Chattanooga
Tennessee Oncology, Pllc Nashville
RECRUITING
Nashville
Texas
Md Anderson Cancer Center
RECRUITING
Houston
Virginia
Virginia Commonwealth University Massey Cancer Center
RECRUITING
Richmond
Washington
Fred Hutchinson Cancer Research Center
RECRUITING
Seattle
Other Locations
Australia
Concord Repatriation General Hospital
RECRUITING
Concord
St Vincents Hospital Melbourne
RECRUITING
Fitzroy
Peninsula Private Hospital
COMPLETED
Frankston
Austin Health
RECRUITING
Heidelberg
Peter Maccallum Cancer Centre
RECRUITING
Melbourne
The Alfred Hospital
RECRUITING
Melbourne
Linear Clinical Research
RECRUITING
Nedlands
Calvary Mater Newcastle
RECRUITING
Waratah
Perth Blood Institute
RECRUITING
West Perth
Princess Alexandra Hospital
RECRUITING
Woolloongabba
Brazil
Hospital Sirio Libanes Brasilia
RECRUITING
Brasília
Instituto de Pesquisa Em Saude Da Universidade de Caxias Do Sul
COMPLETED
Caxias Do Sul
Hospital Erasto Gaertner
RECRUITING
Curitiba
Centro Gaucho Integrado de Oncologia Hospital Mae de Deus
RECRUITING
Porto Alegre
Hospital Ernesto Dornelles
COMPLETED
Porto Alegre
Hospital Alemao Oswaldo Cruz
RECRUITING
São Paulo
Hospital Nove de Julho Dasa
RECRUITING
São Paulo
Instituto Dor de Pesquisa E Ensino Sao Paulo
RECRUITING
São Paulo
Real E Benemerita Associacao Portuguesa de Sao Paulo
RECRUITING
São Paulo
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
RECRUITING
São Paulo
Hospital Santa Rita de Cassia Afecc
RECRUITING
Vitória
Canada
Arthur Je Child Comprehensive Cancer Centre
RECRUITING
Calgary
Cross Cancer Institute
RECRUITING
Edmonton
Chu de Quebec Universite Laval, Hopital de Lenfant Jesus, Centre Integre de Cancerologie (Cic)
RECRUITING
Québec
Princess Margaret Cancer Centre
RECRUITING
Toronto
British Columbia Cancer Agency the Vancouver Centre
RECRUITING
Vancouver
France
Centre de Lutte Contre Le Cancer Institut Bergonie
RECRUITING
Bordeaux
Hopital Estaing
RECRUITING
Clermontferrand
Chu Henri Mondor
RECRUITING
Créteil
Hopital Claude Huriez Chu Lille
RECRUITING
Lille
Centre Leon Berard
RECRUITING
Lyon
Institut Paoli Calmettes
RECRUITING
Marseille
Chu Montpellier Hopital Saint Eloi
RECRUITING
Montpellier
Hopital de La Pitie Salpetriere
RECRUITING
Paris
Centre Henri Becquerel
RECRUITING
Rouen
Georgia
Arensia Exploratory Medicine Llc
ACTIVE_NOT_RECRUITING
Tbilisi
Germany
Uniklinik Koeln (Aoer)
RECRUITING
Cologne
Universitatsklinikum Carl Gustav Carus An Der Technischen Universitat Dresden
RECRUITING
Dresden
Universitares Krebszentrum Leipzig
RECRUITING
Leipzig
Universitaetsklinikum Schleswig Holstein Campus Luebeck
RECRUITING
Lübeck
Klinikum Johannes Gutenberg Universitaet Mainz
RECRUITING
Mainz
Klinikum Grosshadern Ludwig Maximilians Universitat Munchen
RECRUITING
München
Universitaetsklinikum Ulm
RECRUITING
Ulm
Italy
Policlinico Sorsola Malpighi, Aou Di Bologna
RECRUITING
Bologna
Istituto Europeo Di Oncologia
RECRUITING
Milan
Niguarda Cancer Center Division of Hematology
RECRUITING
Milan
Ospedale San Raffaele
RECRUITING
Milan
Fondazione Policlinico Universitario Agostino Gemelli
RECRUITING
Roma
Centroricerche Cliniche Di Verona Srl
RECRUITING
Verona
Japan
Chiba Cancer Center
RECRUITING
Chiba
National Cancer Center Hospital East
NOT_YET_RECRUITING
Kashiwa
Cancer Institute Hospital of Jfcr
RECRUITING
Kotoku
Aichi Cancer Center Hospital Clinical Oncology
RECRUITING
Nagoya
Yokohama Municipal Citizens Hospital
RECRUITING
Yokohama
Republic of Korea
Inje University Busan Paik Hospital
RECRUITING
Busanjingu
Samsung Medical Center
RECRUITING
Gangnamgu
The Catholic University of Korea, Seoul St Marys Hospital
RECRUITING
Seochogu
Severance Hospital Yonsei University Health System
RECRUITING
Seodaemungu
Pusan National University Hospital
RECRUITING
Seogu
Seoul National University Hospital
RECRUITING
Seoul
Asan Medical Center
RECRUITING
Songpagu
Republic of Moldova
The Institute of Oncology, Arensia Exploratory Medicine
RECRUITING
Chisinau
Spain
Hospital de La Santa Creu I Sant Pau
RECRUITING
Barcelona
Hospital Universitario Vall Dhebron
RECRUITING
Barcelona
Hospital General Universitario Gregorio Maranon
RECRUITING
Madrid
Hospital Universitario Fundacion Jimenez Diaz
RECRUITING
Madrid
Hospital Universitario La Paz
RECRUITING
Madrid
Md Anderson Cancer Center Madrid Spain
RECRUITING
Madrid
Hospital Universitario Puerta de Hierro Majadahonda
RECRUITING
Majadahonda
Hospital Clinico Universitario de Valencia
RECRUITING
Valencia
Sweden
Sahlgrenska University Hospital Hematology
RECRUITING
Gothenburg
Karolinska Universitetssjukhuset Solna
RECRUITING
Stockholm
Uppsala Akademiska Sjukhus
COMPLETED
Uppsala
Turkey
Dokuz Eylul University
RECRUITING
Balçova
Erciyes University
RECRUITING
Kayseri
Sakarya Training and Research Hospital
RECRUITING
Sakarya
Ondokuz Mayis University
RECRUITING
Samsun
United Kingdom
Edinburgh Cancer Centre
RECRUITING
Edinburgh
Churchill Hospital Oxford University Hospital Nhs Trust
RECRUITING
Headington
St Jamess University Hospital
RECRUITING
Leeds
Freeman Hospital
RECRUITING
Newcastle Upon Tyne
Nottingham University Hospitals Nhs Trust
RECRUITING
Nottingham
Derriford Hospital
RECRUITING
Plymouth
Contact Information
Primary
BeiGene
clinicaltrials@beigene.com
1.877.828.5568
Backup
Study Director, MD
Time Frame
Start Date: 2021-09-13
Estimated Completion Date: 2029-11
Participants
Target number of participants: 614
Treatments
Experimental: 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.
Experimental: 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.
Experimental: 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.
Experimental: 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.
Experimental: 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.
Experimental: 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.
Experimental: 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.
Sponsors
Leads: BeiGene

This content was sourced from clinicaltrials.gov