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New BTK-Degrader cocktail takes on Hard-to-Treat blood cancers

NCT ID NCT06634589

Disease control Sponsor: BeOne Medicines Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 7 times

Summary

This study is testing a new oral drug called BGB-16673, which breaks down a protein that helps cancer cells grow, in combination with other cancer drugs. It is for people with B-cell cancers (like certain lymphomas) that have come back or stopped responding to treatment. The trial will enroll about 80 participants and will first check safety and the right dose, then look at whether the tumors shrink.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BGB-16673 (a BTK-degrader) taken orally, combined with other drugs such as sonrotoclax, zanubrutinib, mosunetuzumab, glofitamab, or obinutuzumab
What this could lead to
If successful, this could point toward a new treatment option for people with B-cell cancers that have stopped responding to standard therapies.
What could go wrong
This is an early (phase 1b/2) and small (80 participants) trial focused on safety and dosing, so it is too soon to know if the combinations will work. Side effects from the drug combinations are possible and will be closely monitored.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2024

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: * Must sign the informed consent form (ICF) and be capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the ICF * Confirmed diagnosis of a R/R B-cell malignancy * Protocol-defined measurable disease * Stable Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2 * Adequate organ function * Female participants of childbearing potential must be willing to use a highly effective method of birth control and refrain from egg donation for the duration of the study and for ≥ 7 days after the last dose of sonrotoclax, 30 days after the last dose of tacabrutideg or zanubrutinib, 60 days after the last dose of glofitamab, or 90 days after the last dose of mosunetuzumab. A negative urine or serum pregnancy test result must be provided 10-14 days before the first dose of study treatment * Nonsterile male participants must be willing to use a highly effective method of birth control and refrain from sperm donation for the duration of the study and for ≥ 7 days after the last dose of sonrotoclax, 30 days after the last dose of tacabrutideg or zanubrutinib, 60 days after the last dose of glofitamab, or 90 days after the last dose of mosunetuzumab * Substudies 1, 3, and 4 Inclusion Criterion: * Adequate renal function as indicated by estimated glomerular filtration rate (eGFR) of ≥ 50 mL/min * Substudy 2 Inclusion Criteria: * Bruton tyrosine kinase (BTK) inhibitor-naive, or previously received treatment with a covalent BTK inhibitor and discontinued for reasons other than clinical progression * Adequate renal function as indicated by eGFR of ≥ 30 mL/min Key Exclusion Criteria: * Treatment-naive B-cell malignancies * Unable to comply with the requirements of the protocol * Active leptomeningeal disease or uncontrolled, untreated brain metastasis * Any malignancy ≤ 2 years before first dose of study treatment except for the specific cancer under investigation in this study or any locally recurring cancer that has been treated curatively * Autologous stem cell transplant ≤ 3 months prior to screening or chimeric antigen T-cell therapy ≤ 3 months prior to screening * Prior invasive fungal infection, except if participant agrees to receive secondary antifungal prophylaxis during the entire treatment period * Substudies 1 and 2: Prior allogeneic stem cell transplant with active graft-versus-host disease (GVHD), or requiring immunosuppressive drugs for treatment of GVHD, or who have taken calcineurin inhibitors within 4 weeks prior to consent * Participants who have a history of severe allergic reactions or hypersensitivity to the active ingredient and excipients of tacabrutideg, sonrotoclax, zanubrutinib, mosunetuzumab, or glofitamab * Substudy 1 Exclusion Criterion: * Prior treatment with a B-cell lymphoma-2 (Bcl-2) inhibitor (with exception for participants who relapsed ≥ 24 months after completion of a full course of a prior Bcl-2 inhibitor containing regimen) * Substudy 2 Exclusion Criterion: * Participants who discontinued prior zanubrutinib treatment due to intolerance * Substudies 3 and 4 Exclusion Criteria: * Prior exposure to a CD20 x CD3 T-cell engager antibody treatment * All participants with a prior allogeneic stem cell transplant * Participants with known contraindications to azole antifungal agents, including hypersensitivity reactions Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

B-cell neoplasm neoplasm Recurrence refractory malignant neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

B-cell lymphoma B-cell malignancy Refractory cancer Relapsed cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    49 sites in 8 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Auckland City Hospital

    RECRUITING

    Auckland, 1023, New Zealand

  • Azienda Ospedaliera Universitaria Policlinico Santorsola Malpighi

    RECRUITING

    Bologna, 40138, Italy

  • Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

    RECRUITING

    Milan, 20162, Italy

  • Centroricerche Cliniche Di Verona Srl

    RECRUITING

    Verona, 37134, Italy

  • Columbia University Medical Center

    RECRUITING

    New York, New York, 10032, United States

  • Ensino E Terapia de Inovacao Clinica Amo Etica

    RECRUITING

    Salvador, 41950-640, Brazil

  • Fox Chase Cancer Center

    RECRUITING

    Philadelphia, Pennsylvania, 19111-2434, United States

  • Fujian Medical University Union Hospital

    RECRUITING

    Fuzhou, Fujian, 350001, China

  • Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto

    RECRUITING

    São José do Rio Preto, 15090-000, Brazil

  • Hospital Sirio Libanes Brasilia

    RECRUITING

    Brasília, 70200-730, Brazil

  • Huntsman Cancer Institute

    RECRUITING

    Salt Lake City, Utah, 84112-5550, United States

  • Icahn School of Medicine At Mount Sinai

    RECRUITING

    New York, New York, 10029-6504, United States

  • Istituto Clinico Humanitas

    RECRUITING

    Rozzano, 20089, Italy

  • Istituto Nazionale Tumori Fondazione G Pascale

    RECRUITING

    Naples, 80131, Italy

  • Linear Clinical Research

    RECRUITING

    Nedlands, Western Australia, WA 6009, Australia

  • Mater Cancer Care Centre

    RECRUITING

    South Brisbane, Queensland, QLD 4101, Australia

  • Mayo Clinic Jacksonville

    RECRUITING

    Jacksonville, Florida, 32224-1865, United States

  • Mayo Clinic Phoenix

    RECRUITING

    Phoenix, Arizona, 85054-4502, United States

  • Mayo Clinic Rochester

    RECRUITING

    Rochester, Minnesota, 55905-0001, United States

  • Medical College of Wisconsin

    RECRUITING

    Milwaukee, Wisconsin, 53226-3522, United States

  • Medizinische Universitaetsklinik

    RECRUITING

    Tübingen, 72076, Germany

  • Memorial Sloan Kettering Cancer Center Mskcc

    RECRUITING

    New York, New York, 10065-6800, United States

  • Moffitt Cancer Center

    RECRUITING

    Tampa, Florida, 33612-9496, United States

  • Monash Health

    RECRUITING

    Clayton, Victoria, VIC 3168, Australia

  • Narodowy Instytut Onkologii Im Marii Sklodowskiej Curie W Warszawie

    RECRUITING

    Warsaw, 02-781, Poland

  • North Shore Hospital

    RECRUITING

    Auckland, 0622, New Zealand

  • Peter Maccallum Cancer Centre

    RECRUITING

    Melbourne, Victoria, VIC 3000, Australia

  • Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

    RECRUITING

    São Paulo, 05652-900, Brazil

  • St George Hospital

    RECRUITING

    Kogarah, New South Wales, NSW 2217, Australia

  • Sun Yat Sen University Cancer Center

    RECRUITING

    Guangzhou, Guangdong, 510060, China

  • Szpital Kliniczny Mswia Z Warmisko Mazurskim Centrum Onkologii

    RECRUITING

    Olsztyn, 10-228, Poland

  • Szpital Wojewodzki W Opolu Sp Z Oo Oddzia Hematologii I Onkologii Hematologicznej

    RECRUITING

    Opole, 45-061, Poland

  • The Alfred Hospital

    RECRUITING

    Melbourne, Victoria, VIC 3004, Australia

  • The First Affiliated Hospital of Soochow University

    RECRUITING

    Suzhou, Jiangsu, 215006, China

  • The First Affiliated Hospital of Wenzhou Medical University

    RECRUITING

    Wenzhou, Zhejiang, 325000, China

  • The First Affiliated Hospital, Zhejiang University School of Medicinechengzhan

    RECRUITING

    Hangzhou, Zhejiang, 310002, China

  • The University of Kansas Cancer Center

    RECRUITING

    Westwood, Kansas, 66205-2003, United States

  • The University of Texas Md Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030-4009, United States

  • Universitaetsklinikum Ulm

    RECRUITING

    Ulm, 89081, Germany

  • Universitatsklinikum Carl Gustav Carus An Der Technischen Universitat Dresden

    RECRUITING

    Dresden, 01307, Germany

  • Universitatsklinikum Jena Klinik Fur Innere Medizin Ii

    RECRUITING

    Jena, 07747, Germany

  • Universitatsklinikum Schleswig Holstein Campus Kiel

    RECRUITING

    Kiel, 24105, Germany

  • University of Rochester

    RECRUITING

    Rochester, New York, 14642-0001, United States

  • University of Southern California Norris Comprehensive

    RECRUITING

    Los Angeles, California, 90033, United States

  • University of Wisconsin

    RECRUITING

    Madison, Wisconsin, 53792-0001, United States

  • Uniwersytecki Szpital Kliniczny Nr 1 W Lublinie

    RECRUITING

    Lublin, 20-081, Poland

  • Uniwersyteckie Centrum Kliniczne

    RECRUITING

    Gdansk, 80-214, Poland

  • Washington University School of Medicine

    RECRUITING

    St Louis, Missouri, 63110-1010, United States

  • Weill Cornell Medical College Newyork Presbyterian Hospital

    RECRUITING

    New York, New York, 10065-4870, United States

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