B-cell MalignancyPhase 1/2CaDAnCe-101NCT05006716
A Dose-Escalation and Expansion Study of Tacabrutideg (BGB-16673) in Participants With B-Cell Malignancies
A Phase 1/2 study testing Tacabrutideg in people with B-cell Malignancy and Marginal Zone Lymphoma, run by BeOne Medicines at 114 sites in 16 countries.
Trial summary
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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- B-cell Malignancy, Marginal Zone Lymphoma, Follicular Lymphoma
- What is being tested?
- Tacabrutideg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 689 participants
- Where
- 114 sitesin 16 countries
- Study dates
- 13 Sep 2021to Mar 2030
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
114 sites in 16 countries. Contact the study team or a site near you to ask about taking part.
Study Director, MD contact
114 sites in 16 countries
United States31 sites, 28 recruiting
- Recruiting
Augusta University
Augusta, Georgia, 30912-0002
- Recruiting
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, 70809-3738
- Recruiting
American Oncology Partners of Maryland Pa
Bethesda, Maryland, 20817-7847
- Recruiting
University of Alabama At Birmingham Hospital
Birmingham, Alabama, 35294-0004
- Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, 02215-5418
- Recruiting
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14203
- Recruiting
Tennesse Oncology Chattanooga Downtown
Chattanooga, Tennessee, 37404
- Recruiting
Karmanos Cancer Institute
Detroit, Michigan, 48201-2013
- Recruiting
Uchealth North
Fort Collins, Colorado, 80528-3413
- Recruiting
Md Anderson Cancer Center
Houston, Texas, 77030-3907
- Recruiting
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242-1009
- Recruiting
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224-1865
- Recruiting
University of California San Diego (Ucsd) Moores Cancer Center
La Jolla, California, 92093-1503
- Recruiting
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169-3321
- Active, not recruiting
Norton Cancer Institute Pavilion
Louisville, Kentucky, 40207-4700
- Recruiting
Mount Sinai Medical Center Braman Comprehensive Cancer Center
Miami, Florida, 33140
- Recruiting
Tennessee Oncology, Pllc Nashville
Nashville, Tennessee, 37203
- Recruiting
Columbia University Medical Center
New York, New York, 10032
- Recruiting
Weill Cornell Medical College Newyork Presbyterian Hospital
New York, New York, 10065-4870
- Recruiting
Memorial Sloan Kettering Cancer Center Mskcc
New York, New York, 10065-6800
- Recruiting
Southeastern Regional Medical Center
Newnan, Georgia, 30265-8001
- Recruiting
Stanford Medicine
Palo Alto, California, 94304-2205
- Completed
Mayo Clinic Phoenix
Phoenix, Arizona, 85054-4502
- Recruiting
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, 23298
- Recruiting
Mayo Clinic Rochester
Rochester, Minnesota, 55905-0001
- Recruiting
UCLA Santa Monica Cancer Care
Santa Monica, California, 90404-2023
- Recruiting
Honor Health Research Institute
Scottsdale, Arizona, 85258-4566
- Recruiting
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-4433
- Recruiting
Tampa General Hospital Cancer Institute
Tampa, Florida, 33606-3571
- Recruiting
University of Arizona Cancer Center
Tucson, Arizona, 85724-0001
- Completed
Midwestern Regional Medical Center
Zion, Illinois, 60099-2676
Australia9 sites, 9 recruiting
- Recruiting
Concord Repatriation General Hospital
Concord, New South Wales, NSW 2139
- Recruiting
St Vincents Hospital Melbourne
Fitzroy, Victoria, VIC 3065
- Recruiting
Austin Health
Heidelberg, Victoria, VIC 3084
- Recruiting
Peter Maccallum Cancer Centre
Melbourne, Victoria, VIC 3000
- Recruiting
The Alfred Hospital
Melbourne, Victoria, VIC 3004
- Recruiting
Linear Clinical Research
Nedlands, Western Australia, WA 6009
- Recruiting
Calvary Mater Newcastle
Waratah, New South Wales, NSW 2298
- Recruiting
Perth Blood Institute
West Perth, Western Australia, WA 6005
- Recruiting
Princess Alexandra Hospital
Woolloongabba, Queensland, QLD 4102
France9 sites, 9 recruiting
- Recruiting
Centre de Lutte Contre Le Cancer Institut Bergonie
Bordeaux, 33076
- Recruiting
Hopital Estaing
ClermontFerrand, 63100
- Recruiting
Chu Henri Mondor
Créteil, 94000
- Recruiting
Hopital Claude Huriez Chu Lille
Lille, 59000
- Recruiting
Centre Leon Berard
Lyon, 69373
- Recruiting
Institut Paoli Calmettes
Marseille, 13009
- Recruiting
Chu Montpellier Hopital Saint Eloi
Montpellier, 34090
- Recruiting
Hopital de La Pitie Salpetriere
Paris, 75013
- Recruiting
Centre Henri Becquerel
Rouen, 76038
Brazil7 sites, 7 recruiting
- Recruiting
Hospital Sirio Libanes Brasilia
Brasília, 70200-730
- Recruiting
Hospital Erasto Gaertner
Curitiba, 81520-060
- Recruiting
Centro Gaucho Integrado de Oncologia Hospital Mae de Deus
Porto Alegre, 90110-270
- Recruiting
Real E Benemerita Associacao Portuguesa de Sao Paulo
São Paulo, 01321-001
- Recruiting
Instituto Dor de Pesquisa E Ensino Sao Paulo
São Paulo, 01401-004
- Recruiting
Hospital Nove de Julho Dasa
São Paulo, 01409-001
- Recruiting
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
São Paulo, 05652-900
China7 sites
- Active, not recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
- Active, not recruiting
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515
- Active, not recruiting
Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025
- Active, not recruiting
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciencestuanbo Branch
Tianjin, Tianjin Municipality, 301617
- Active, not recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
- Active, not recruiting
Yichang Central Peoples Hospitaljiangnan Branch
Yichang, Hubei, 443001
- Active, not recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450000
Germany7 sites, 7 recruiting
- Recruiting
Uniklinik Koeln (Aoer)
Cologne, 50937
- Recruiting
Universitatsklinikum Carl Gustav Carus An Der Technischen Universitat Dresden
Dresden, 01307
- Recruiting
Universitares Krebszentrum Leipzig
Leipzig, 04103
- Recruiting
Universitaetsklinikum Schleswig Holstein Campus Luebeck
Lübeck, 23538
- Recruiting
Klinikum Johannes Gutenberg Universitaet Mainz
Mainz, 55131
- Recruiting
Klinikum Grosshadern Ludwig Maximilians Universitat Munchen
München, 81377
- Recruiting
Universitaetsklinikum Ulm
Ulm, 89081
Spain7 sites, 7 recruiting
- Recruiting
Hospital Universitario Vall Dhebron
Barcelona, 08035
- Recruiting
Hospital General Universitario Gregorio Maranon
Madrid, 28007
- Recruiting
Md Anderson Cancer Center Madrid Spain
Madrid, 28033
- Recruiting
Hospital Universitario Fundacion Jimenez Diaz
Madrid, 28040
- Recruiting
Hospital Universitario La Paz
Madrid, 28046
- Recruiting
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, 28222
- Recruiting
Hospital Clinico Universitario de Valencia
Valencia, 46010
United Kingdom7 sites, 7 recruiting
- Recruiting
Edinburgh Cancer Centre
Edinburgh, EH4 2XU
- Recruiting
St Jamess University Hospital
Leeds, LS9 7TF
- Recruiting
Freeman Hospital
Newcastle upon Tyne, NE7 7DN
- Recruiting
Genesiscare Cambridge
Newmarket, CB8 7XN
- Recruiting
Norfolk and Norwich University Hospitals Nhs Foundation Trust
Norwich, NR4 7UY
- Recruiting
Nottingham University Hospitals Nhs Trust
Nottingham, NG5 1PB
- Recruiting
Derriford Hospital
Plymouth, PL6 8DH
Italy6 sites, 6 recruiting
- Recruiting
Policlinico Sorsola Malpighi, Aou Di Bologna
Bologna, 40138
- Recruiting
Ospedale San Raffaele
Milan, 20132
- Recruiting
Istituto Europeo Di Oncologia
Milan, 20141
- Recruiting
Niguarda Cancer Center Division of Hematology
Milan, 20162
- Recruiting
Fondazione Policlinico Universitario Agostino Gemelli
Roma, 00168
- Recruiting
Centroricerche Cliniche Di Verona Srl
Verona, 37134
South Korea6 sites, 6 recruiting
- Recruiting
Samsung Medical Center
GangnamGu, Seoul Teugbyeolsi, 06351
- Recruiting
The Catholic University of Korea, Seoul St Marys Hospital
SeochoGu, Seoul Teugbyeolsi, 06591
- Recruiting
Severance Hospital Yonsei University Health System
SeodaemunGu, Seoul Teugbyeolsi, 03722
- Recruiting
Pusan National University Hospital
Seogu, Busan Gwang'Yeogsi, 49241
- Recruiting
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, 03080
- Recruiting
Asan Medical Center
SongpaGu, Seoul Teugbyeolsi, 05505
Canada5 sites, 5 recruiting
- Recruiting
Arthur Je Child Comprehensive Cancer Centre
Calgary, Alberta, T2N 5G2
- Recruiting
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
- Recruiting
Chu de Quebec Universite Laval, Hopital de Lenfant Jesus, Centre Integre de Cancerologie (Cic)
Québec, Quebec, G1J 1Z4
- Recruiting
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
- Recruiting
British Columbia Cancer Agency the Vancouver Centre
Vancouver, British Columbia, V5Z 4E6
Japan5 sites, 5 recruiting
- Recruiting
Chiba Cancer Center
Chiba, Chiba, 260-8717
- Recruiting
National Cancer Center Hospital East
Kashiwa, Chiba, 277-8577
- Recruiting
Cancer Institute Hospital of Jfcr
Kotoku, Tokyo, 135-8550
- Recruiting
Aichi Cancer Center Hospital Clinical Oncology
Nagoya, Aichi-ken, 464-8681
- Recruiting
Yokohama Municipal Citizens Hospital
Yokohama, 221-0855
Turkey (Türkiye)4 sites, 4 recruiting
- Recruiting
Dokuz Eylul University
Balçova, 35330
- Recruiting
Erciyes University
Kayseri, 38030
- Recruiting
Sakarya Training and Research Hospital
Sakarya, 54100
- Recruiting
Ondokuz Mayis University
Samsun, 55200
Sweden2 sites, 2 recruiting
- Recruiting
Sahlgrenska University Hospital Hematology
Gothenburg, 413 46
- Recruiting
Karolinska Universitetssjukhuset Solna
Stockholm, 171 76
Georgia1 site, 1 recruiting
- Recruiting
Arensia Exploratory Medicine Llc
Tbilisi, 0119
Moldova1 site, 1 recruiting
- Recruiting
The Institute of Oncology, Arensia Exploratory Medicine
Chisinau, 2025
About this study
Official title: 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
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)
Read the detailed description
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.
- Conditions
- B-cell Malignancy, Marginal Zone Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoma, Waldenström Macroglobulinemia, Chronic Lymphocytic Leukemia
- Being tested
- Tacabrutideg
- Medical subject headings
- Lymphoma, B-Cell, Marginal Zone, Lymphoma, Follicular, Lymphoma, Non-Hodgkin, Waldenstrom Macroglobulinemia, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Mantle-Cell, Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TacabrutidegDrug
Also called BGB-16673
Orally administered
| Study group | Role | What they receive |
|---|---|---|
| Part 1a (Monotherapy Dose Escalation) | Experimental | 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. Receives: Drug: Tacabrutideg |
| Part 1b (Monotherapy Safety Expansion) | Experimental | 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. Receives: Drug: Tacabrutideg |
| Part 1c (Additional Monotherapy Safety Expansion) | Experimental | 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. Receives: Drug: Tacabrutideg |
| Part 1d (Additional Monotherapy Safety Expansion in R/R CLL/SLL) | Experimental | Participants with R/R CLL/SLL will be enrolled at selected RDFE(s) to generate additional safety and efficacy data for tacabrutideg. Receives: Drug: Tacabrutideg |
| Part 1e (Japan-only Cohort) | Experimental | 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. Receives: Drug: Tacabrutideg |
| Part 1f (Additional Monotherapy Safety Expansion in BTKi Naive B-Cell Malignancies) | Experimental | 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. Receives: Drug: Tacabrutideg |
| Phase 2 (Monotherapy Expansion) | Experimental | 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. Receives: Drug: Tacabrutideg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1: Number of Participants with Adverse Events (AEs)
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.
Measured: 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
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.
Measured: Approximately 28 days
Phase 1: Recommended dose(s) for Expansion (RDFE) of tacabrutideg
RDFE of tacabrutideg alone will be determined based upon the MTD or MAD.
Measured: Approximately 3 years
Phase 2: Overall response rate (ORR)
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.
Measured: approximately 3 years
Secondary outcomes (30)
Single dose and steady-state maximum observed plasma concentration (Cmax) of tacabrutideg
Measured: 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.
Single dose and steady-state minimum observed plasma concentration (Cmin) of tacabrutideg
Measured: 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.
Single dose and steady-state time to reach Cmax (tmax) of tacabrutideg
Measured: 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.
Single dose and steady-state elimination half-life (T1/2) of tacabrutideg
Measured: 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.
Single dose and steady-state area under the plasma concentration-time curve (AUC) of tacabrutideg
Measured: 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.
Single dose and steady-state apparent total clearance of drug from plasma after oral administration (CL/F) of tacabrutideg
Measured: 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.
Single dose and steady-state apparent volume of distribution (Vz/F) of tacabrutideg
Measured: 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.
Single dose and steady-state accumulation ratios of tacabrutideg
Measured: 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.
Bruton's tyrosine kinase (BTK) protein degradation in peripheral blood after tacabrutideg monotherapy
Measured: 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.
Phase 1: Overall response rate (ORR)
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.
Measured: approximately 3 years
Phase 1: Response Rate in Participants with R/R CLL/SLL
Defined as the percentage of participants with R/R CLL/SLL whose best overall response is better than stable disease, as determined by investigators.
Measured: approximately 3 years
Phase 1: Overall Response Rate in Participants with R/R WM
Defined as the percentage of participants with R/R WM who have a response rate of minor response or better.
Measured: approximately 3 years
Phase 1: Number of Participants with AEs in part 1e (Japan-only cohort)
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.
Measured: 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)
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.
Measured: approximately 3 years
Phase 2: Number of Participants with AEs
Number of participants with TEAEs and SAEs, including results from laboratory assessments, ECGs, and physical examinations, graded according to the NCI-CTCAE v5.0.
Measured: 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
Defined as the percentage of participants with CLL/SLL with a best overall response of PR or better, as determined by investigators.
Measured: approximately 3 years
Phase 2: Major Response Rate for Participants with WM assessed by investigator
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.
Measured: approximately 3 years
Phase 2: Overall Response Rate for Participants with WM assessed by investigator and IRC
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.
Measured: approximately 3 years
Phase 2: Rate of Very Good Partial Response (VGPR) or Better in Participants with WM Assessed by Investigator and IRC
Defined as the percentage of participants with R/R WM with best response of VGPR or better as determined by IRC and investigator.
Measured: approximately 3 years
Phase 2: Response Rate in Participants with R/R CLL/SLL Assessed by Investigator and IRC
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.
Measured: approximately 3 years
Phase 2: Duration of Response (DOR)
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.
Measured: approximately 3 years
Phase 2: Time to Overall Response (TTOR)
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
Measured: approximately 3 years
Phase 2: Time to Major Response (TTMR) in Participants with WM
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.
Measured: approximately 3 years
Phase 2: Time to Response in Participants with R/R CLL/SLL Assessed by Investigator and IRC
Defined as the time to first response based on best overall response of better than stable disease, per IRC and investigator.
Measured: approximately 3 years
Phase 2: Time to Response in Participants with WM Assessed by Investigator and IRC
Defined as the time to first response based on best overall response of minor response or better, per IRC and investigator.
Measured: approximately 3 years
Phase 2: Time to Next Treatment (TTNT)
Defined as the time from the treatment start date to the initiation of subsequent anticancer therapy.
Measured: approximately 3 years
Phase 2: Progression- Free Survival (PFS)
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.
Measured: approximately 3 years
Phase 2: Overall Survival (OS)
OS is defined as the time from first study drug administration to the date of death due to any cause
Measured: approximately 3 years
Phase 2: Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu) questionnaire
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.
Measured: 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)
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.
Measured: Baseline and day 1 of Weeks 5, 13, 25, and 37
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2021
- Study start13 Sep 2021
- Primary completionMar 2027 (estimated)
- Study completionMar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B-cell MalignancyStudies of the same condition, open and under way.
- More trials run by BeOne MedicinesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 689 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BeOne Medicines
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, BeOne Medicines
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05006716
- Sponsor's protocol ID
- BGB-16673-101
- Other IDs
- 2022-502157-33-00
- Acronym
- CaDAnCe-101
- Status last verified
- Sep 2026
- First submitted
- 9 Aug 2021
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.