Taking people in GeorgiaPhase 1/2

Tests tacabrutideg in adults with B-cell blood cancers

Tests tacabrutideg in adults with B-cell lymphoma or leukemia.

Plain-language title generated from the registry record
Registry title: A Dose-Escalation and Expansion Study of Tacabrutideg (BGB-16673) in Participants With B-Cell Malignancies

Key facts

Where: Tbilisi, GeorgiaSee the site
Phase: Phase 1/2

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with certain B-cell blood cancers or lymphomas, such as CLL/SLL, mantle cell lymphoma, follicular lymphoma, marginal zone lymphoma, Waldenström macroglobulinemia or DLBCL.

Age: 18 years or older
Sex: Men and women can join.
Disease stage: Confirmed diagnosis of marginal zone lymphoma, follicular lymphoma (R/R), mantle cell lymphoma, CLL/SLL, Waldenström macroglobulinemia, diffuse large B-cell lymphoma (R/R) or Richter's transformation to DLBCL. The disease must be measurable on imaging, or by serum IgM level in Waldenström macroglobulinemia. ECOG performance status 0 to 2.
Earlier treatment: If you had a covalent BTK inhibitor before, you must have taken it for at least 8 weeks, unless you stopped because you could not tolerate it. In the first part of the study, people who had a BTK inhibitor or who never had one can join, depending on diagnosis and country. In the later part (Phase 2), people with mantle cell lymphoma must have had a BTK inhibitor before. People with CLL/SLL must have had both a BTK inhibitor and a Bcl-2 inhibitor.

Main reasons for not taking part

Another cancer in the past 2 years, with a few exceptions
Needs ongoing treatment for another cancer
Needs ongoing steroid treatment of 10 mg/day of prednisone or equivalent or more
Current or past involvement of the brain or spinal cord by the B-cell cancer
Certain other lymphoma or leukemia types, such as Burkitt lymphoma, T-cell lymphoma or hairy cell leukemia

Read by machine on 9 November 2026.

Where in Georgia

ARENSIA Exploratory Medicine LLCTbilisi, GeorgiaContact: BeOne MedicinesTaking people

Questions to ask the study team

How often do I need to come in, and for how long each time?
Are travel costs paid?
Can I keep my own doctor?
What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Trial details

Who runs it: BeOne Medicines
Trial code: NCT05006716 EU 2022-502157-33-00
Record updated: 5 October 2026
Original description: 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 full original descriptionShow less
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)
Inclusion: 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: 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; 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; 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.
ClinicalTrials.gov NCT05006716 · EU CTIS 2022-502157-33-00