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RecruitingPhase 1 / Phase 2

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants will make regular visits to the clinic for treatment, health checks, blood tests, and tumor and imaging tests."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests tacabrutideg (BGB-16673) alone in people with certain B-cell cancers, which affect a type of white blood cell. It tests different doses and checks safety to help choose recommended doses, then studies the drug in more groups of patients.

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)

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You must have a confirmed diagnosis of an eligible B-cell cancer: marginal zone, follicular, mantle cell, or diffuse large B-cell lymphoma; CLL/SLL; Waldenström macroglobulinemia; or Richter’s transformation to diffuse large B-cell lymphoma. Follicular and diffuse large B-cell lymphoma must have returned or not responded to treatment.
  • If you took a covalent BTK inhibitor, a type of cancer drug, you must have taken it for at least 8 weeks unless you stopped because you could not tolerate it.
  • If you previously took a covalent BTK inhibitor, your cancer must have worsened during or after treatment, or you must have stopped because of harmful or hard-to-tolerate side effects.
  • Your cancer must be measurable on scans. For Waldenström macroglobulinemia, it may instead be measured by the blood level of a protein called IgM.
  • You must be able to care for yourself and be up and about for at least half of your waking hours, even if you cannot work.
  • In the dose-finding part, whether you need past BTK inhibitor treatment depends on your cancer type and country.
  • In Phase 2, people with mantle cell lymphoma must have had a BTK inhibitor. People with CLL/SLL must have had both a BTK inhibitor and a BCL-2 inhibitor, another type of cancer drug.

Who can't join

  • You had another cancer within the past 2 years. Some exceptions apply for certain early cancers or cancers treated to cure them and judged unlikely to return.
  • You need ongoing treatment that acts throughout the body for another cancer.
  • You need ongoing steroid treatment that acts throughout the body, at a dose of at least 10 mg of prednisone daily or an equal dose of another steroid.
  • Your B-cell cancer affects, or has ever affected, your brain, spinal cord, or the tissues or fluid around them, even if it was treated.
  • You have certain other active blood cancers or related diseases ruled out by the study. These include several leukemia and lymphoma types and specific forms of diffuse large B-cell lymphoma; the study team must check your exact diagnosis.
  • You have, or may have, a slow-growing lymphoma that changed into a fast-growing one. Exceptions in Parts 1a, 1c, and Phase 2 include Richter’s transformation to diffuse large B-cell lymphoma and past follicular lymphoma that changed to the non-GCB type of diffuse large B-cell lymphoma.
  • Other study rules may also affect whether you can join.

Simplified for readability. The official criteria below are what the study team uses.

Official 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. Measurable disease by radiographic assessment or serum IgM level (WM only) 5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2 6. 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.

Study sites (31)

AL

AZ

CA

CO

FL

GA

IA

IL

KY

LA

MA

MD

MI

MN

NV

NY

TN

TX

VA

WA