ClinicalTrials.gov record NCT05006716
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
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This Phase 1/2, open-label study tests oral tacabrutideg (BGB-16673) in people with various B‑cell malignancies. The study first escalates doses to find recommended dose(s), then expands those doses in disease-specific cohorts to collect more safety and response data. Participants have regular clinic visits for treatment, safety checks, blood tests, and tumor imaging over about three years.
What it is studying. The study is testing whether the oral drug tacabrutideg can be given safely, what dose(s) are appropriate, and how participants' cancers and bodies respond. It will measure side effects, find a maximum tolerated or maximum administered dose, recommend dose(s) for expansion, and collect response data (for example overall response rate). The study also measures drug levels in blood and the drug's effect on the BTK protein.
What the researchers hope to learn. Determine safety and tolerability of tacabrutideg; identify the maximum tolerated or maximum administered dose and the recommended dose(s) for expansion; measure anti-cancer activity (overall response rate) in several B‑cell malignancy cohorts; characterize pharmacokinetics and BTK protein degradation; collect additional safety and patient-reported outcome data.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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)
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Drug
- Tacabrutideg
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
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.
Study description and what participation involves
The study's detailed description, as published on ClinicalTrials.gov.
Show the detailed description from the registry
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.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Participants take the study drug tacabrutideg by mouth and make regular clinic visits for treatment and safety checks over approximately 3 years. Visits include blood samples (including detailed pharmacokinetic draws and measurements of BTK protein in peripheral blood), electrocardiograms (ECGs), physical exams, and tumor/imaging assessments. Participants complete symptom and quality-of-life questionnaires at scheduled times. Study staff record side effects and other results (the registry lists many timed blood-sampling windows and periodic imaging and lab monitoring).
How the study is structured. Open-label Phase 1/2 study with dose-escalation and multiple safety-expansion cohorts (Parts 1a–1f) followed by Phase 2 expansion cohorts. All study groups are experimental and receive oral tacabrutideg (BGB-16673). The registry lists allocation as randomized and masking as none (open-label). The study collects safety data, response assessments, and pharmacokinetic/pharmacodynamic measurements over planned follow-up.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- This is an early-phase study, mainly about safety and dose. What is already known about this treatment?
- The listed sites are in Australia, Brazil, Canada, China, France, Georgia, Germany, Italy, Japan, Moldova, South Korea, Spain, Sweden, Turkey, United Kingdom, United States. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on Waldenström macroglobulinemia
Important dates
- Study start
- Sep 13, 2021
- Primary completion
- March 2027 (estimated)
- Study completion
- March 2030 (estimated)
- Target enrollment
- 689 participants (estimated)
- Last updated on registry
- Oct 5, 2026
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- BeOne Medicines
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- BeOne Medicines 📞 1.877.828.5568 ✉ clinicaltrials@beonemed.com
- Study Director, MD
Participating sites (114)
- University of Alabama At Birmingham HospitalRecruiting
Birmingham, Alabama, 35294-0004 · United States
- Mayo Clinic PhoenixCompleted
Phoenix, Arizona, 85054-4502 · United States
- Honor Health Research InstituteRecruiting
Scottsdale, Arizona, 85258-4566 · United States
- University of Arizona Cancer CenterRecruiting
Tucson, Arizona, 85724-0001 · United States
- University of California San Diego (Ucsd) Moores Cancer CenterRecruiting
La Jolla, California, 92093-1503 · United States
- Stanford MedicineRecruiting
Palo Alto, California, 94304-2205 · United States
- UCLA Santa Monica Cancer CareRecruiting
Santa Monica, California, 90404-2023 · United States
- Uchealth NorthRecruiting
Fort Collins, Colorado, 80528-3413 · United States
- Mayo Clinic JacksonvilleRecruiting
Jacksonville, Florida, 32224-1865 · United States
- Mount Sinai Medical Center Braman Comprehensive Cancer CenterRecruiting
Miami, Florida, 33140 · United States
Terms used on this page · explanations by MedicalUpdates.ai
- Phase 1
- An early-stage study, usually small, mainly to check safety, side effects and how much of a treatment can be given. Whether it works is not the main question yet.
- dose finding
- Groups of participants receive increasing doses of a treatment, one group after another, to find a dose that can be given safely.
- Phase 2
- A study that tests whether a treatment has the intended effect and continues to check safety, usually in a larger group than phase 1.
- line of therapy
- Treatment a person has already had for the condition. A 'line of therapy' is one course of treatment; studies often require, or limit, the number of prior lines.
- ECOG
- A scale from 0 to 5 that describes how a person's condition affects daily activity. 0 means fully active; 1 means restricted in strenuous activity; 2 means able to self-care but unable to work; higher numbers mean more limitation.
- enrollment
- The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
- prednisone
- Steroid medicines, such as prednisone, that reduce inflammation. Studies often require a stable dose at entry or measure whether the study treatment allows the dose to be reduced.
- biopsy
- Removal of a small piece of tissue so it can be examined under a microscope. 'Biopsy-proven' or 'histologically confirmed' means the diagnosis was confirmed by examining tissue under a microscope.
- Exclusion criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- study drug
- A treatment that is being tested and has not been approved for this use. It may be approved for a different condition. Being studied does not mean it works or is available outside the study.
- open label
- No masking is used, so the assigned intervention is not deliberately hidden from participants or study staff.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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