NCT05006716From ClinicalTrials.govRecruiting

A Dose-Escalation and Expansion Study of Tacabrutideg (BGB-16673) in Participants With B-Cell Malignancies

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

B-cell Malignancy
Marginal Zone Lymphoma
Follicular Lymphoma
Non-Hodgkin Lymphoma
Waldenström Macroglobulinemia
Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
Mantle Cell Lymphoma

At a glance

Phase: Phase 1
Study type: Interventional
Sponsor: BeOne Medicines
Enrolment target: 645
Started: 13 September 2021
Main results due: November 2026
Study sites: 114
Registry updated: 28 September 2026

Can you take part?

Aged 18 years and over.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria

Inclusion Criteria :

1. 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.
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. Phase 2 Cohorts in R/R CLL/SLL, R/R MCL, and R/R WM only: Participants who previously received a BTKi are eligible if they had disease progression on only one regimen containing a covalent BTKi. Note: Participants may have received treatment with ≥ 2 different covalent BTKis if additional BTKis were discontinued secondary to an event other than disease progression.
5. Measurable disease by radiographic assessment or serum IgM level (WM only)
6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
7. 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:

1. 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.
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).

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

What this study is about

In the sponsor’s own words, from the registry.

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)

Study sites(114)

University of Alabama At Birmingham Hospital
Birmingham, Alabama, United States
Recruiting
Mayo Clinic Phoenix
Phoenix, Arizona, United States
Completed
Honor Health Research Institute
Scottsdale, Arizona, United States
Recruiting
University of Arizona Cancer Center
Tucson, Arizona, United States
Recruiting
University of California San Diego (Ucsd) Moores Cancer Center
La Jolla, California, United States
Recruiting
Stanford Medicine
Palo Alto, California, United States
Recruiting
UCLA Santa Monica Cancer Care
Santa Monica, California, United States
Recruiting
Uchealth North
Fort Collins, Colorado, United States
Recruiting
Mayo Clinic Jacksonville
Jacksonville, Florida, United States
Recruiting
Mount Sinai Medical Center Braman Comprehensive Cancer Center
Miami, Florida, United States
Recruiting
Tampa General Hospital Cancer Institute
Tampa, Florida, United States
Recruiting
Augusta University
Augusta, Georgia, United States
Recruiting
Southeastern Regional Medical Center
Newnan, Georgia, United States
Recruiting
Midwestern Regional Medical Center
Zion, Illinois, United States
Completed
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Recruiting
Norton Cancer Institute Pavilion
Louisville, Kentucky, United States
Active, not recruiting
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, United States
Recruiting
American Oncology Partners of Maryland Pa
Bethesda, Maryland, United States
Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Recruiting
Karmanos Cancer Institute
Detroit, Michigan, United States
Recruiting
Mayo Clinic Rochester
Rochester, Minnesota, United States
Recruiting
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
Recruiting
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States
Recruiting
Columbia University Medical Center
New York, New York, United States
Recruiting
Weill Cornell Medical College Newyork Presbyterian Hospital
New York, New York, United States
Recruiting
Memorial Sloan Kettering Cancer Center Mskcc
New York, New York, United States
Recruiting
Tennesse Oncology Chattanooga Downtown
Chattanooga, Tennessee, United States
Recruiting
Tennessee Oncology, Pllc Nashville
Nashville, Tennessee, United States
Recruiting
Md Anderson Cancer Center
Houston, Texas, United States
Recruiting
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, United States
Recruiting
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Recruiting
Concord Repatriation General Hospital
Concord, New South Wales, Australia
Recruiting
Calvary Mater Newcastle
Waratah, New South Wales, Australia
Recruiting
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Recruiting
St Vincents Hospital Melbourne
Fitzroy, Victoria, Australia
Recruiting
Austin Health
Heidelberg, Victoria, Australia
Recruiting
Peter Maccallum Cancer Centre
Melbourne, Victoria, Australia
Recruiting
The Alfred Hospital
Melbourne, Victoria, Australia
Recruiting
Linear Clinical Research
Nedlands, Western Australia, Australia
Recruiting
Perth Blood Institute
West Perth, Western Australia, Australia
Recruiting
Hospital Sirio Libanes Brasilia
Brasília, Brazil
Recruiting
Hospital Erasto Gaertner
Curitiba, Brazil
Recruiting
Centro Gaucho Integrado de Oncologia Hospital Mae de Deus
Porto Alegre, Brazil
Recruiting
Real E Benemerita Associacao Portuguesa de Sao Paulo
São Paulo, Brazil
Recruiting
Instituto Dor de Pesquisa E Ensino Sao Paulo
São Paulo, Brazil
Recruiting
Hospital Nove de Julho Dasa
São Paulo, Brazil
Recruiting
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
São Paulo, Brazil
Recruiting
Arthur Je Child Comprehensive Cancer Centre
Calgary, Alberta, Canada
Recruiting
Cross Cancer Institute
Edmonton, Alberta, Canada
Recruiting
British Columbia Cancer Agency the Vancouver Centre
Vancouver, British Columbia, Canada
Recruiting
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Recruiting
Chu de Quebec Universite Laval, Hopital de Lenfant Jesus, Centre Integre de Cancerologie (Cic)
Québec, Quebec, Canada
Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Active, not recruiting
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
Active, not recruiting
Henan Cancer Hospital
Zhengzhou, Henan, China
Active, not recruiting
Yichang Central Peoples Hospitaljiangnan Branch
Yichang, Hubei, China
Active, not recruiting
Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Active, not recruiting
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciencestuanbo Branch
Tianjin, Tianjin Municipality, China
Active, not recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Active, not recruiting
Centre de Lutte Contre Le Cancer Institut Bergonie
Bordeaux, France
Recruiting

Showing 60 of 114 sites — filter to narrow it down. 104 of the 114 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT05006716. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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