Fáze 1 studie eskalace a rozšíření dávky BGB-16673 u pacientů s malignitami B-buněk (CaDAnCe-101)
Fáze 1, otevřená studie, eskalace dávky a expanze přípravku Bruton Tyrosinkinase-Targeted Protein-Degrader BGB-16673 u pacientů s malignitami B-buněk
Study consists of two main parts to explore tacabrutideg 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)
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
A B-cell malignancy is a type of cancer that starts in white blood cells called B-cells. These cancers can affect the lymph nodes, bone marrow, blood, spleen, and other organs. Examples of these cancers include chronic lymphocytic leukemia/small lymphocytic lymphoma, marginal zone lymphoma, follicular lymphoma, Waldenström macroglobulinemia, mantle cell lymphoma, and diffuse large B cell lymphoma.
Tacabrutideg is a type of medicine called a BTK degrader. BTK (Bruton's tyrosine kinase) is a protein that helps cancer cells survive. Tacabrutideg is designed to attach to the BTK protein and tag it for removal, so that the body's own cellular "clean-up" system breaks it down and clears it away. When more BTK is removed from the body, it interferes with the signals needed for the cancer cells to multiply and survive and may also reduce the chance of the cancer becoming resistant to treatment.
The purpose of this study is to test whether tacabrutideg is safe and if it can treat B-cell malignancies. The main goals are to ensure the drug is safe by monitoring side effects and to understand how well patients respond to the treatment and whether their cancers shrink or disappear.
This study consists of two parts: dose escalation and dose expansion. During the dose escalation part, the study doctors will test different doses of the study drug to find the recommended dose that people can take without having serious side effects. During the dose expansion part, the study doctors will test the study drug in a larger number of people using the dose or doses identified from dose escalation. The study is open label, which means that the participants and the study doctors will know what treatment is received.
This study will enroll approximately 689 participants with B-cell malignancies at multiple centers worldwide.
The overall time to participate in this study is approximately 3 years. Participants will make regular visits to the clinic for treatment, health checks, blood tests, and tumor and imaging tests.
Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.
Typ studie
Zápis (Odhadovaný)
Fáze
- Fáze 2
- Fáze 1
Kontakty a umístění
Studijní kontakt
- Jméno: Study Director, MD
Studijní záloha kontaktů
- Jméno: BeOne Medicines
- Telefonní číslo: 1.877.828.5568
- E-mail: clinicaltrials@beonemed.com
Studijní místa
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New South Wales
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Concord, New South Wales, Austrálie, NSW 2139
- Nábor
- Concord Repatriation General Hospital
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Waratah, New South Wales, Austrálie, NSW 2298
- Nábor
- Calvary Mater Newcastle
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Queensland
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Woolloongabba, Queensland, Austrálie, QLD 4102
- Nábor
- Princess Alexandra Hospital
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Victoria
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Fitzroy, Victoria, Austrálie, VIC 3065
- Nábor
- St Vincents Hospital Melbourne
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Heidelberg, Victoria, Austrálie, VIC 3084
- Nábor
- Austin Health
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Melbourne, Victoria, Austrálie, VIC 3004
- Nábor
- The Alfred Hospital
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Melbourne, Victoria, Austrálie, VIC 3000
- Nábor
- Peter Maccallum Cancer Centre
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Western Australia
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Nedlands, Western Australia, Austrálie, WA 6009
- Nábor
- Linear Clinical Research
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West Perth, Western Australia, Austrálie, WA 6005
- Nábor
- Perth Blood Institute
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Brasília, Brazílie, 70200-730
- Nábor
- Hospital Sirio Libanes Brasilia
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Curitiba, Brazílie, 81520-060
- Nábor
- Hospital Erasto Gaertner
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Porto Alegre, Brazílie, 90110-270
- Nábor
- Centro Gaucho Integrado de Oncologia Hospital Mae de Deus
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São Paulo, Brazílie, 05652-900
- Nábor
- Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
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São Paulo, Brazílie, 01321-001
- Nábor
- Real E Benemerita Associacao Portuguesa de Sao Paulo
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São Paulo, Brazílie, 01409-001
- Nábor
- Hospital Nove de Julho Dasa
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São Paulo, Brazílie, 01401-004
- Nábor
- Instituto Dor de Pesquisa E Ensino Sao Paulo
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Bordeaux, Francie, 33076
- Nábor
- Centre de Lutte Contre Le Cancer Institut Bergonie
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ClermontFerrand, Francie, 63100
- Nábor
- Hopital Estaing
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Créteil, Francie, 94000
- Nábor
- Chu Henri Mondor
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Lille, Francie, 59000
- Nábor
- Hopital Claude Huriez Chu Lille
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Lyon, Francie, 69373
- Nábor
- Centre Leon Berard
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Marseille, Francie, 13009
- Nábor
- Institut Paoli Calmettes
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Montpellier, Francie, 34090
- Nábor
- Chu Montpellier Hopital Saint Eloi
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Paris, Francie, 75013
- Nábor
- Hopital de La Pitie Salpetriere
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Rouen, Francie, 76038
- Nábor
- Centre Henri Becquerel
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Tbilisi, Gruzie, 0119
- Nábor
- Arensia Exploratory Medicine Llc
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Bologna, Itálie, 40138
- Nábor
- Policlinico Sorsola Malpighi, Aou Di Bologna
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Milan, Itálie, 20132
- Nábor
- Ospedale San Raffaele
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Milan, Itálie, 20162
- Nábor
- Niguarda Cancer Center Division of Hematology
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Milan, Itálie, 20141
- Nábor
- Istituto Europeo Di Oncologia
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Roma, Itálie, 00168
- Nábor
- Fondazione Policlinico Universitario Agostino Gemelli
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Verona, Itálie, 37134
- Nábor
- Centroricerche Cliniche Di Verona Srl
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Yokohama, Japonsko, 221-0855
- Nábor
- Yokohama Municipal Citizens Hospital
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Aichi-ken
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Nagoya, Aichi-ken, Japonsko, 464-8681
- Nábor
- Aichi Cancer Center Hospital Clinical Oncology
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Chiba
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Chiba, Chiba, Japonsko, 260-8717
- Nábor
- Chiba Cancer Center
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Kashiwa, Chiba, Japonsko, 277-8577
- Nábor
- National Cancer Center Hospital East
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Tokyo
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Kotoku, Tokyo, Japonsko, 135-8550
- Nábor
- Cancer Institute Hospital of Jfcr
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Busan Gwang'Yeogsi
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Seogu, Busan Gwang'Yeogsi, Jižní Korea, 49241
- Nábor
- Pusan National University Hospital
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Seoul Teugbyeolsi
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GangnamGu, Seoul Teugbyeolsi, Jižní Korea, 06351
- Nábor
- Samsung Medical Center
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SeochoGu, Seoul Teugbyeolsi, Jižní Korea, 06591
- Nábor
- The Catholic University of Korea, Seoul St Marys Hospital
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SeodaemunGu, Seoul Teugbyeolsi, Jižní Korea, 03722
- Nábor
- Severance Hospital Yonsei University Health System
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Seoul, Seoul Teugbyeolsi, Jižní Korea, 03080
- Nábor
- Seoul National University Hospital
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SongpaGu, Seoul Teugbyeolsi, Jižní Korea, 05505
- Nábor
- Asan Medical Center
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Alberta
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Calgary, Alberta, Kanada, T2N 5G2
- Nábor
- Arthur Je Child Comprehensive Cancer Centre
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Edmonton, Alberta, Kanada, T6G 1Z2
- Nábor
- Cross Cancer Institute
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British Columbia
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Vancouver, British Columbia, Kanada, V5Z 4E6
- Nábor
- British Columbia Cancer Agency the Vancouver Centre
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Ontario
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Toronto, Ontario, Kanada, M5G 2M9
- Nábor
- Princess Margaret Cancer Centre
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Quebec
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Québec, Quebec, Kanada, G1J 1Z4
- Nábor
- Chu de Quebec Universite Laval, Hopital de Lenfant Jesus, Centre Integre de Cancerologie (Cic)
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Chisinau, Moldavsko, 2025
- Nábor
- The Institute of Oncology, Arensia Exploratory Medicine
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Cologne, Německo, 50937
- Nábor
- Uniklinik Koeln (Aoer)
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Dresden, Německo, 01307
- Nábor
- Universitatsklinikum Carl Gustav Carus An Der Technischen Universitat Dresden
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Leipzig, Německo, 04103
- Nábor
- Universitares Krebszentrum Leipzig
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Lübeck, Německo, 23538
- Nábor
- Universitaetsklinikum Schleswig Holstein Campus Luebeck
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Mainz, Německo, 55131
- Nábor
- Klinikum Johannes Gutenberg Universitaet Mainz
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München, Německo, 81377
- Nábor
- Klinikum Grosshadern Ludwig Maximilians Universitat Munchen
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Ulm, Německo, 89081
- Nábor
- Universitaetsklinikum Ulm
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Edinburgh, Spojené království, EH4 2XU
- Nábor
- Edinburgh Cancer Centre
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Leeds, Spojené království, LS9 7TF
- Nábor
- St Jamess University Hospital
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Newcastle upon Tyne, Spojené království, NE7 7DN
- Nábor
- Freeman Hospital
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Newmarket, Spojené království, CB8 7XN
- Nábor
- Genesiscare Cambridge
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Norwich, Spojené království, NR4 7UY
- Nábor
- Norfolk and Norwich University Hospitals Nhs Foundation Trust
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Nottingham, Spojené království, NG5 1PB
- Nábor
- Nottingham University Hospitals Nhs Trust
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Plymouth, Spojené království, PL6 8DH
- Nábor
- Derriford Hospital
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Alabama
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Birmingham, Alabama, Spojené státy, 35294-0004
- Nábor
- University of Alabama At Birmingham Hospital
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Arizona
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Phoenix, Arizona, Spojené státy, 85054-4502
- Dokončeno
- Mayo Clinic Phoenix
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Scottsdale, Arizona, Spojené státy, 85258-4566
- Nábor
- Honor Health Research Institute
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Tucson, Arizona, Spojené státy, 85724-0001
- Nábor
- University of Arizona Cancer Center
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California
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La Jolla, California, Spojené státy, 92093-1503
- Nábor
- University of California San Diego (Ucsd) Moores Cancer Center
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Palo Alto, California, Spojené státy, 94304-2205
- Nábor
- Stanford Medicine
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Santa Monica, California, Spojené státy, 90404-2023
- Nábor
- UCLA Santa Monica Cancer Care
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Colorado
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Fort Collins, Colorado, Spojené státy, 80528-3413
- Nábor
- Uchealth North
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Florida
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Jacksonville, Florida, Spojené státy, 32224-1865
- Nábor
- Mayo Clinic Jacksonville
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Miami, Florida, Spojené státy, 33140
- Nábor
- Mount Sinai Medical Center Braman Comprehensive Cancer Center
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Tampa, Florida, Spojené státy, 33606-3571
- Nábor
- Tampa General Hospital Cancer Institute
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Georgia
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Augusta, Georgia, Spojené státy, 30912-0002
- Nábor
- Augusta University
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Newnan, Georgia, Spojené státy, 30265-8001
- Nábor
- Southeastern Regional Medical Center
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Illinois
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Zion, Illinois, Spojené státy, 60099-2676
- Dokončeno
- Midwestern Regional Medical Center
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Iowa
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Iowa City, Iowa, Spojené státy, 52242-1009
- Nábor
- University of Iowa Hospitals and Clinics
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Kentucky
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Louisville, Kentucky, Spojené státy, 40207-4700
- Aktivní, ne nábor
- Norton Cancer Institute Pavilion
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Louisiana
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Baton Rouge, Louisiana, Spojené státy, 70809-3738
- Nábor
- Mary Bird Perkins Cancer Center
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Maryland
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Bethesda, Maryland, Spojené státy, 20817-7847
- Nábor
- American Oncology Partners of Maryland Pa
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Massachusetts
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Boston, Massachusetts, Spojené státy, 02215-5418
- Nábor
- Dana Farber Cancer Institute
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Michigan
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Detroit, Michigan, Spojené státy, 48201-2013
- Nábor
- Karmanos Cancer Institute
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Minnesota
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Rochester, Minnesota, Spojené státy, 55905-0001
- Nábor
- Mayo Clinic Rochester
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Nevada
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Las Vegas, Nevada, Spojené státy, 89169-3321
- Nábor
- Comprehensive Cancer Centers of Nevada
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New York
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Buffalo, New York, Spojené státy, 14203
- Nábor
- Roswell Park Comprehensive Cancer Center
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New York, New York, Spojené státy, 10032
- Nábor
- Columbia University Medical Center
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New York, New York, Spojené státy, 10065-6800
- Nábor
- Memorial Sloan Kettering Cancer Center Mskcc
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New York, New York, Spojené státy, 10065-4870
- Nábor
- Weill Cornell Medical College Newyork Presbyterian Hospital
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Tennessee
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Chattanooga, Tennessee, Spojené státy, 37404
- Nábor
- Tennesse Oncology Chattanooga Downtown
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Nashville, Tennessee, Spojené státy, 37203
- Nábor
- Tennessee Oncology, Pllc Nashville
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Texas
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Houston, Texas, Spojené státy, 77030-3907
- Nábor
- Md Anderson Cancer Center
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Virginia
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Richmond, Virginia, Spojené státy, 23298
- Nábor
- Virginia Commonwealth University Massey Cancer Center
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Washington
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Seattle, Washington, Spojené státy, 98109-4433
- Nábor
- Fred Hutchinson Cancer Research Center
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Balçova, Turecko (Türkiye), 35330
- Nábor
- Dokuz Eylul University
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Kayseri, Turecko (Türkiye), 38030
- Nábor
- Erciyes University
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Sakarya, Turecko (Türkiye), 54100
- Nábor
- Sakarya Training and Research Hospital
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Samsun, Turecko (Türkiye), 55200
- Nábor
- Ondokuz Mayis University
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Beijing Municipality
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Beijing, Beijing Municipality, Čína, 100730
- Aktivní, ne nábor
- Peking Union Medical College Hospital
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Guangdong
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Guangzhou, Guangdong, Čína, 510515
- Aktivní, ne nábor
- Nanfang Hospital, Southern Medical University
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Henan
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Zhengzhou, Henan, Čína, 450000
- Aktivní, ne nábor
- Henan Cancer Hospital
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Hubei
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Yichang, Hubei, Čína, 443001
- Aktivní, ne nábor
- Yichang Central Peoples Hospitaljiangnan Branch
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Čína, 200025
- Aktivní, ne nábor
- Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
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Tianjin Municipality
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Tianjin, Tianjin Municipality, Čína, 301617
- Aktivní, ne nábor
- Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciencestuanbo Branch
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Zhejiang
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Wenzhou, Zhejiang, Čína, 325000
- Aktivní, ne nábor
- The First Affiliated Hospital of Wenzhou Medical University
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Barcelona, Španělsko, 08035
- Nábor
- Hospital Universitario Vall Dhebron
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Madrid, Španělsko, 28046
- Nábor
- Hospital Universitario La Paz
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Madrid, Španělsko, 28033
- Nábor
- Md Anderson Cancer Center Madrid Spain
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Madrid, Španělsko, 28007
- Nábor
- Hospital General Universitario Gregorio Maranon
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Madrid, Španělsko, 28040
- Nábor
- Hospital Universitario Fundacion Jimenez Diaz
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Majadahonda, Španělsko, 28222
- Nábor
- Hospital Universitario Puerta de Hierro Majadahonda
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Valencia, Španělsko, 46010
- Nábor
- Hospital Clinico Universitario de Valencia
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Gothenburg, Švédsko, 413 46
- Nábor
- Sahlgrenska University Hospital Hematology
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Stockholm, Švédsko, 171 76
- Nábor
- Karolinska Universitetssjukhuset Solna
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria :
- 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).
Exclusion Criteria:
- Prior malignancy (other than the disease under study) within the past 2 years, except in situ malignancies that have been curatively resected, localized breast cancer treated with curative intent with no evidence of breast active disease for more than 3 years and receiving adjuvant hormonal therapy, localized Gleason score ≤ 6 prostate cancer undergoing observation or treatment with androgen depravation, or any other cancer treated with curative intent, not on adjuvant treatment, and in the opinion of the investigator is unlikely to recur.
- Requires ongoing systemic treatment for any other malignancy
- Requires ongoing systemic (defined as ≥ 10 mg/day of prednisone or equivalent) corticosteroid treatment.
- 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
- 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).
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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 tacabrutideg. |
Orally administered
Ostatní jména:
|
|
Experimentální: 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 tacabrutideg. |
Orally administered
Ostatní jména:
|
|
Experimentální: 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 tacabrutideg for those with non-CLL/SLL/MCL histologies. |
Orally administered
Ostatní jména:
|
|
Experimentální: 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 tacabrutideg. |
Orally administered
Ostatní jména:
|
|
Experimentální: 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 tacabrutideg. |
Orally administered
Ostatní jména:
|
|
Experimentální: 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. |
Orally administered
Ostatní jména:
|
|
Experimentální: 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 tacabrutideg. |
Orally administered
Ostatní jména:
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Phase 1: Number of Participants with Adverse Events (AEs)
Časové okno: From the first dose of tacabrutideg until 30 days after the last dose of the study drug or before the initiation of a new anticancer therapy, whichever occurs first (Up to 47 weeks)
|
Number of participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) including results from laboratory assessments, electrocardiograms (ECGs), and physical examinations, and that meet protocol-defined dose-limiting toxicities (DLTs); as graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0. |
From the first dose of tacabrutideg until 30 days after the last dose of the study drug or before the initiation of a new anticancer therapy, whichever occurs first (Up to 47 weeks)
|
|
Phase 1: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of Tacabrutideg
Časové okno: Approximately 28 days
|
MTD is defined as the highest evaluated dose with an estimated toxicity rate closest to the target, while MAD is the highest dose given if MTD is not reached. |
Approximately 28 days
|
|
Phase 1: Recommended dose(s) for Expansion (RDFE) of tacabrutideg
Časové okno: Approximately 3 years
|
RDFE of tacabrutideg alone will be determined based upon the MTD or MAD. |
Approximately 3 years
|
|
Phase 2: Overall response rate (ORR)
Časové okno: approximately 3 years
|
Defined as the percentage of participants achieving a best overall response of partial response (PR) or better, assessed by the Independent Review Committee for participants with R/R CLL/SLL and R/R WM (in participants with WM, this is also referred to as major response rate) and by the investigator for other cohorts (R/R MCL, R/R MZL, R/R FL, R/R non-GCB DLBCL, R/R Richter's transformation to DLBCL), evaluated using the Lugano criteria for NHL and SLL, International Workshop of Chronic Lymphocytic Leukemia (iwCLL) criteria for CLL, and the 11th International Workshop on Waldenstrom's Macroglobulinemia (IWWM-11) criteria for WM. |
approximately 3 years
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Single dose and steady-state maximum observed plasma concentration (Cmax) of tacabrutideg
Časové okno: Week 1 Day 1 pre-dose; 2, 4, 6, 8, 24, 48, and 72 hours post-dose; Week 5 Day 1 pre-dose; and 2, 4, 6, 8 post-dose; Week 9 Day 1 pre-dose.
|
Week 1 Day 1 pre-dose; 2, 4, 6, 8, 24, 48, and 72 hours post-dose; Week 5 Day 1 pre-dose; and 2, 4, 6, 8 post-dose; Week 9 Day 1 pre-dose.
|
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Single dose and steady-state minimum observed plasma concentration (Cmin) of tacabrutideg
Časové okno: Week 1 Day 1 pre-dose; 2, 4, 6, 8, 24, 48, and 72 hours post-dose; Week 5 Day 1 pre-dose; and 2, 4, 6, 8 post-dose; Week 9 Day 1 pre-dose.
|
Week 1 Day 1 pre-dose; 2, 4, 6, 8, 24, 48, and 72 hours post-dose; Week 5 Day 1 pre-dose; and 2, 4, 6, 8 post-dose; Week 9 Day 1 pre-dose.
|
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Single dose and steady-state time to reach Cmax (tmax) of tacabrutideg
Časové okno: Week 1 Day 1 pre-dose; 2, 4, 6, 8, 24, 48, and 72 hours post-dose; Week 5 Day 1 pre-dose; and 2, 4, 6, 8 post-dose; Week 9 Day 1 pre-dose.
|
Week 1 Day 1 pre-dose; 2, 4, 6, 8, 24, 48, and 72 hours post-dose; Week 5 Day 1 pre-dose; and 2, 4, 6, 8 post-dose; Week 9 Day 1 pre-dose.
|
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Single dose and steady-state elimination half-life (T1/2) of tacabrutideg
Časové okno: Week 1 Day 1 pre-dose; 2, 4, 6, 8, 24, 48, and 72 hours post-dose; Week 5 Day 1 pre-dose; and 2, 4, 6, 8 post-dose; Week 9 Day 1 pre-dose.
|
Week 1 Day 1 pre-dose; 2, 4, 6, 8, 24, 48, and 72 hours post-dose; Week 5 Day 1 pre-dose; and 2, 4, 6, 8 post-dose; Week 9 Day 1 pre-dose.
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Single dose and steady-state area under the plasma concentration-time curve (AUC) of tacabrutideg
Časové okno: Week 1 Day 1 pre-dose; 2, 4, 6, 8, 24, 48, and 72 hours post-dose; Week 5 Day 1 pre-dose; and 2, 4, 6, 8 post-dose; Week 9 Day 1 pre-dose.
|
Week 1 Day 1 pre-dose; 2, 4, 6, 8, 24, 48, and 72 hours post-dose; Week 5 Day 1 pre-dose; and 2, 4, 6, 8 post-dose; Week 9 Day 1 pre-dose.
|
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Single dose and steady-state apparent total clearance of drug from plasma after oral administration (CL/F) of tacabrutideg
Časové okno: Week 1 Day 1 pre-dose; 2, 4, 6, 8, 24, 48, and 72 hours post-dose; Week 5 Day 1 pre-dose; and 2, 4, 6, 8 post-dose; Week 9 Day 1 pre-dose.
|
Week 1 Day 1 pre-dose; 2, 4, 6, 8, 24, 48, and 72 hours post-dose; Week 5 Day 1 pre-dose; and 2, 4, 6, 8 post-dose; Week 9 Day 1 pre-dose.
|
|
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Single dose and steady-state apparent volume of distribution (Vz/F) of tacabrutideg
Časové okno: Week 1 Day 1 pre-dose; 2, 4, 6, 8, 24, 48, and 72 hours post-dose; Week 5 Day 1 pre-dose; and 2, 4, 6, 8 post-dose; Week 9 Day 1 pre-dose.
|
Week 1 Day 1 pre-dose; 2, 4, 6, 8, 24, 48, and 72 hours post-dose; Week 5 Day 1 pre-dose; and 2, 4, 6, 8 post-dose; Week 9 Day 1 pre-dose.
|
|
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Single dose and steady-state accumulation ratios of tacabrutideg
Časové okno: Week 1 Day 1 pre-dose; 2, 4, 6, 8, 24, 48, and 72 hours post-dose; Week 5 Day 1 pre-dose; and 2, 4, 6, 8 post-dose; Week 9 Day 1 pre-dose.
|
Week 1 Day 1 pre-dose; 2, 4, 6, 8, 24, 48, and 72 hours post-dose; Week 5 Day 1 pre-dose; and 2, 4, 6, 8 post-dose; Week 9 Day 1 pre-dose.
|
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Bruton's tyrosine kinase (BTK) protein degradation in peripheral blood after tacabrutideg monotherapy
Časové okno: Week 1 Day 1 pre-dose; 8, 24, 48, and 72 hours post-dose; Week 5 Day 1 pre-dose and 8 hours post-dose; Week 9 Day 1 pre-dose.
|
Week 1 Day 1 pre-dose; 8, 24, 48, and 72 hours post-dose; Week 5 Day 1 pre-dose and 8 hours post-dose; Week 9 Day 1 pre-dose.
|
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Phase 1: Overall response rate (ORR)
Časové okno: approximately 3 years
|
Defined as the percentage of participants whose best overall response is partial response or better, as assessed by the investigator and evaluated according to the following criteria: the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria for R/R CLL, the International Workshop on Waldenström's Macroglobulinemia (IWWM-11) criteria for R/R WM (in participants with WM, this is also referred to as major response rate), and the Lugano criteria for R/R NHL. |
approximately 3 years
|
|
Phase 1: Response Rate in Participants with R/R CLL/SLL
Časové okno: approximately 3 years
|
Defined as the percentage of participants with R/R CLL/SLL whose best overall response is better than stable disease, as determined by investigators. |
approximately 3 years
|
|
Phase 1: Overall Response Rate in Participants with R/R WM
Časové okno: approximately 3 years
|
Defined as the percentage of participants with R/R WM who have a response rate of minor response or better. |
approximately 3 years
|
|
Phase 1: Number of Participants with AEs in part 1e (Japan-only cohort)
Časové okno: From the first dose of tacabrutideg in Part 1e until 30 days after the last dose of the study drug or before the initiation of a new anticancer therapy, whichever occurs first (approximately 3 years)
|
Number of Japanese participants in Part 1e with TEAEs and SAEs, including results from laboratory assessments, ECGs, and physical examinations, that meet protocol-defined DLTs, graded according to the NCI-CTCAE v5.0. |
From the first dose of tacabrutideg in Part 1e until 30 days after the last dose of the study drug or before the initiation of a new anticancer therapy, whichever occurs first (approximately 3 years)
|
|
Phase 2: Recommended Phase 2 Dose (RP2D)
Časové okno: approximately 3 years
|
The Recommended Phase 2 Dose (RP2D) is determined by the sponsor based on the Safety Monitoring Committee's recommendations, taking into account the overall clinical safety, efficacy, pharmacokinetic (PK), and pharmacodynamic data. |
approximately 3 years
|
|
Phase 2: Number of Participants with AEs
Časové okno: From the first dose of tacabrutideg in Phase 2 until 30 days after the last dose of the study drug or before the initiation of a new anticancer therapy, whichever occurs first (approximately 3 years)
|
Number of participants with TEAEs and SAEs, including results from laboratory assessments, ECGs, and physical examinations, graded according to the NCI-CTCAE v5.0. |
From the first dose of tacabrutideg in Phase 2 until 30 days after the last dose of the study drug or before the initiation of a new anticancer therapy, whichever occurs first (approximately 3 years)
|
|
Phase 2: ORR in Participants with CLL/SLL assessed by investigators
Časové okno: approximately 3 years
|
Defined as the percentage of participants with CLL/SLL with a best overall response of PR or better, as determined by investigators. |
approximately 3 years
|
|
Phase 2: Major Response Rate for Participants with WM assessed by investigator
Časové okno: approximately 3 years
|
Defined as the percentage of participants with WM whose best overall response is PR or better, as determined by investigators using the IWWM-11 criteria. |
approximately 3 years
|
|
Phase 2: Overall Response Rate for Participants with WM assessed by investigator and IRC
Časové okno: approximately 3 years
|
Defined as the percentage of participants who achieve at least a minor response (MR) or a more favorable outcome, as assessed by investigators for participants with R/R WM. |
approximately 3 years
|
|
Phase 2: Rate of Very Good Partial Response (VGPR) or Better in Participants with WM Assessed by Investigator and IRC
Časové okno: approximately 3 years
|
Defined as the percentage of participants with R/R WM with best response of VGPR or better as determined by IRC and investigator. |
approximately 3 years
|
|
Phase 2: Response Rate in Participants with R/R CLL/SLL Assessed by Investigator and IRC
Časové okno: approximately 3 years
|
Defined as the percentage of participants with R/R CLL/SLL whose best overall response is better than stable disease, as determined by IRC and investigator. |
approximately 3 years
|
|
Phase 2: Duration of Response (DOR)
Časové okno: approximately 3 years
|
DOR is defined as the time from the date that response criteria are first met to the date that progressive disease is documented or death, whichever comes first as assessed by the investigator and the IRC. |
approximately 3 years
|
|
Phase 2: Time to Overall Response (TTOR)
Časové okno: approximately 3 years
|
TTOR is defined as the time from study treatment start to date of the earliest qualifying response (partial response or better), as assessed by IRC and the investigator |
approximately 3 years
|
|
Phase 2: Time to Major Response (TTMR) in Participants with WM
Časové okno: approximately 3 years
|
Defined as the time from the date of treatment initiation to the date of first response of PR or better in participants with R/R WM. |
approximately 3 years
|
|
Phase 2: Time to Response in Participants with R/R CLL/SLL Assessed by Investigator and IRC
Časové okno: approximately 3 years
|
Defined as the time to first response based on best overall response of better than stable disease, per IRC and investigator. |
approximately 3 years
|
|
Phase 2: Time to Response in Participants with WM Assessed by Investigator and IRC
Časové okno: approximately 3 years
|
Defined as the time to first response based on best overall response of minor response or better, per IRC and investigator. |
approximately 3 years
|
|
Phase 2: Time to Next Treatment (TTNT)
Časové okno: approximately 3 years
|
Defined as the time from the treatment start date to the initiation of subsequent anticancer therapy. |
approximately 3 years
|
|
Phase 2: Progression- Free Survival (PFS)
Časové okno: approximately 3 years
|
PFS is defined as the time from first dose until first documentation of progression or death, whichever comes first, as assessed by IRC for R/R CLL/SLL and R/R WM and by the investigator for all participants. |
approximately 3 years
|
|
Phase 2: Overall Survival (OS)
Časové okno: approximately 3 years
|
OS is defined as the time from first study drug administration to the date of death due to any cause |
approximately 3 years
|
|
Phase 2: Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu) questionnaire
Časové okno: Baseline and day 1 of Weeks 5, 13, 25, and 37
|
Mean change from baseline in the 'physical well-being' and 'functional well-being' subscales of the FACT-Leu for participants with R/R CLL/SLL. FACT-Leu is a 44-item PRO questionnaire with five subscales used to measure health-related quality of life (HRQoL) in leukemia patients. |
Baseline and day 1 of Weeks 5, 13, 25, and 37
|
|
Phase 2: National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Lymphoma Cancer Symptom Index - 18 (NFLymSI-18)
Časové okno: Baseline and day 1 of Weeks 5, 13, 25, and 37
|
Mean change from baseline in the NFlymSI-18 subscales of disease-related symptoms (DRSP) and 'treatment side effects' for participants with R/R MCL and participants with R/R WM. The NFlymSI-18 is an 18-item patient-reported outcome (PRO) tool specifically designed to assess symptoms and treatment impacts in patients with non-Hodgkin lymphoma. |
Baseline and day 1 of Weeks 5, 13, 25, and 37
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Ředitel studie: Study Director, BeOne Medicines
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
- Cévní onemocnění
- Kardiovaskulární choroby
- Patologické procesy
- Novotvary
- Chronické onemocnění
- Atributy nemoci
- Onemocnění imunitního systému
- Novotvary podle histologického typu
- Hematologická onemocnění
- Lymfatická onemocnění
- Lymfoproliferativní poruchy
- Imunoproliferativní poruchy
- Leukémie, B-buňka
- Lymfom, B-buňka
- Lymfom
- Novotvary, plazmatické buňky
- Hemostatické poruchy
- Paraproteinémie
- Poruchy krevních bílkovin
- Hemoragické poruchy
- Leukémie, lymfoidní
- Leukémie
- Patologické stavy, příznaky a symptomy
- Hemická a lymfatická onemocnění
- Lymfom, velký B-buňka, difuzní
- Leukémie, lymfocytární, chronická, B-buňky
- Lymfom, Non-Hodgkin
- Lymfom, folikulární
- Lymfom, plášťová buňka
- Waldenstromova makroglobulinémie
- Lymfom, B-buňka, okrajová zóna
Další identifikační čísla studie
- BGB-16673-101
- 2022-502157-33-00 (Jiný identifikátor: EU CT Number)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
BeOne shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved.
BeOne shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations.
Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.
Časový rámec sdílení IPD
See plan description
Kritéria přístupu pro sdílení IPD
See plan description
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
- CSR
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
produkt vyrobený a vyvážený z USA
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