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Study of BGB-16673 in combination with drug therapy for patients with relapsed or refractory B-cell malignancies

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is studying treatments for B-cell malignancies that have returned or not responded to previous treatments. The study will test different combinations of medications, including BGB-16673, zanubrutinib, sonrotoclax, mosunetuzumab, obinutuzumab, and glofitamab. The purpose is to find safe and effective treatment combinations for patients whose cancer has come back or did not respond to earlier treatments.

The medications will be given in different ways - some as tablets taken by mouth and others through an intravenous infusion (given directly into a vein) or subcutaneous injection (given under the skin). The study will be conducted in two parts. The first part will determine the right dose of the drug combinations, while the second part will further study how well these doses work and what side effects they may cause.

Throughout the study, doctors will monitor patients' health, check how well the treatment is working, and track any side effects. They will look at how many patients respond to treatment and how long the response lasts. For some patients, they will also measure the amount of cancer cells remaining in the blood or bone marrow after treatment.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial Treatment Phase

    You will receive a combination of medications to treat relapsed or refractory B-cell malignancies (a type of blood cell disorder that has returned or did not respond to previous treatment)

    The main medication, BGB-16673, will be given as tablets that you take by mouth

    Depending on your assigned treatment group, you may also receive other medications through different methods:

    - Gazyvaro (obinutuzumab) through intravenous infusion (through a vein)

    - Zanubrutinib as oral capsules

    - Columvi (glofitamab) through intravenous infusion

    - Mosunetuzumab as an injection under the skin

  2. Step 2

    Monitoring Period

    Your health status will be regularly checked through various tests and examinations

    Doctors will monitor for any side effects or reactions to the medications

    The effectiveness of the treatment will be assessed through blood tests and other medical examinations

    Your response to treatment will be measured, including how long it takes for the treatment to work and how long the response lasts

  3. Step 3

    Safety Assessments

    Regular checks will be performed to monitor:

    - Any side effects that may occur during treatment

    - How well your organs are functioning

    - Your overall health status

    Blood samples will be taken to check the levels of medications in your body

  4. Step 4

    Follow-up Period

    After completing the treatment, you will need to continue using birth control methods for a specified period:

    - 30 days after the last dose of BGB-16673 or zanubrutinib

    - 90 days after the last dose of sonrotoclax

    - 3 months after the last dose of mosunetuzumab

    - 18 months after obinutuzumab treatment

    - 2 months after the last dose of glofitamab

Who can join the trial?

13 criteria

  • Must be able to understand and sign the informed consent form and follow all requirements listed in it
  • Must have a confirmed diagnosis of relapsed or refractory B-cell malignancy (cancer that has returned or did not respond to previous treatment)
  • Must have disease that can be measured according to the study protocol
  • Must have good physical function with an ECOG Performance Status of 0-1 (able to perform daily activities with minimal limitations)
  • Must have adequate organ function
  • Must have adequate kidney function with:
    • For Sub-study 2: eGFR (kidney filtration rate) of ≥30 mL/min
    • For Sub-studies 1, 3 and 4: eGFR of ≥50 mL/min
    • For Sub-study 2: Must be either new to BTK inhibitor treatment or have stopped previous BTK inhibitor treatment for reasons other than disease progression
    • For women who can become pregnant:
      • Must use effective birth control during the study
      • Must not donate eggs during the study and for specified time after last treatment
      • Must have negative pregnancy test 10-14 days before starting treatment
      • For men who are not sterile:
        • Must use effective birth control during the study
        • Must not donate sperm during the study and for specified time after last treatment

Who cannot join the trial?

15 criteria

  • Age below 18 years old
  • Known active central nervous system (CNS) involvement from B-cell malignancy
  • Previous treatment with similar therapy (BGB-16673) or participation in another clinical trial within 30 days
  • Presence of active, uncontrolled infections
  • Significant heart problems, including heart failure or unstable heart rhythm
  • Severe kidney or liver problems
  • Pregnant or breastfeeding women
  • History of other cancers within the past 3 years (except for successfully treated non-melanoma skin cancer or cervical cancer in situ)
  • Known HIV infection (human immunodeficiency virus)
  • Active hepatitis B or C infection
  • Major surgery within 4 weeks before starting the study
  • Mental conditions that could interfere with study participation
  • Known allergic reactions to similar medications
  • Uncontrolled high blood pressure
  • Any other serious medical condition that could make participation unsafe
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Investigated drugs

BGB-16673 is an experimental medication known as a BTK-degrader. It works by breaking down a specific protein (BTK) that is important in B-cell cancers. This medication is being studied in combination with other treatments for patients who have B-cell blood cancers that have either come back or didn't respond well to previous treatments. The trial description mentions that other agents will be combined with BGB-16673, but specific names of these additional medications are not provided in the source data.

What is already known about the treatment

BGB-16673 - An investigational BTK (Bruton's tyrosine kinase) degrader medication that is currently being studied in clinical trials for the treatment of relapsed or refractory B-cell malignancies. This novel therapeutic agent works by breaking down BTK proteins, which play a crucial role in B-cell development and survival. The medication is being evaluated in combination with other agents as part of a Phase 1b/2 clinical trial to determine its safety profile, optimal dosing, and therapeutic effectiveness. While specific administration details are still under investigation in the clinical trial setting, this drug represents a new approach to targeting BTK in patients whose blood cancers have returned or become resistant to previous treatments.

Investigated diseases

B-Cell Malignancies - A group of blood cancers that develop from abnormal B lymphocytes, which are white blood cells that normally help fight infections. These disorders begin in the bone marrow, where B-cells are produced. As abnormal B-cells accumulate, they can spread to various parts of the body, including lymph nodes, blood, and other tissues. The condition can progress from an initial stage where there are too many abnormal B-cells to more advanced stages affecting multiple body systems. The disease can occur in various forms, including different types of lymphomas and leukemias. B-cell malignancies can be either slow-growing (indolent) or fast-growing (aggressive).
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-516234-35-00Protocol codeBGB-16673-104Estimated enrolment370 patientsSponsorBeOne Medicines AG

sourced from the EU Clinical Trials Register and site verification

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