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Investigating a new cancer treatment for relapsed or refractory B-cell malignancies

A Phase 1b/2, Open-Label, Master Protocol Study of BTK-Degrader BGB-16673 in Combination With Other Agents in Patients With Relapsed or Refractory B-Cell Malignancies

PHASE1; PHASE2 · BeOne Medicines · NCT06634589

This study is testing a new cancer drug called BGB-16673 combined with other treatments to see if it can help people with tough-to-treat B-cell cancers feel better.

Quick facts

PhasePHASE1; PHASE2
Study typeInterventional
Enrollment80 (estimated)
Ages18 Years and up
SexAll
SponsorBeOne Medicines (industry)
Drugs / interventionsglofitamab, mosunetuzumab, zanubrutinib
Locations50 sites (Phoenix, Arizona and 49 other locations)
Trial IDNCT06634589 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the safety and effectiveness of a potential anticancer drug, BGB-16673, when used in combination with other agents for patients with relapsed or refractory B-cell malignancies. It is structured as a master protocol with multiple substudies, each focusing on different combination therapies, including sonrotoclax, zanubrutinib, mosunetuzumab, and glofitamab. Participants will be monitored for safety, preliminary antitumor activity, pharmacokinetics, and pharmacodynamics throughout the treatment process.

Who should consider this trial

Good fit: Ideal candidates include individuals with a confirmed diagnosis of relapsed or refractory B-cell malignancies and measurable disease.

Not a fit: Patients with stable B-cell malignancies that are not relapsed or refractory may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat B-cell malignancies.

How similar studies have performed: Other studies have shown promise with similar combination therapies in treating B-cell malignancies, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 BGB-16673 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 BGB-16673 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 BGB-16673, 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.

Where this trial is running

Phoenix, Arizona and 49 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: B-cell Malignancy, Relapsed Cancer, Refractory Cancer, B-cell Lymphoma, R/R B-Cell Malignancies, relapsed or refractory B-Cell Malignancies, B-Cell malignancy, BGB-16673

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.