Recruiting
Phase 1
Phase 2

BGB-16673, Agents

Sponsor:

BeOne Medicines

Code:

NCT06634589

Conditions

B-cell Malignancy

Relapsed Cancer

Refractory Cancer

B-cell Lymphoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Tacabrutideg

Sonrotoclax

Zanubrutinib

Mosunetuzumab

Glofitamab

Study Details

Brief summary:

The purpose of this study is to measure the safety, preliminary antitumor activity, pharmacokinetics, and pharmacodynamics with tacabrutideg in combination with other agents in participants with relapsed or refractory (R/R) B-cell malignancies. This study is structured as a master protocol with separate substudies. This study currently includes four substudies, and more substudies may be added as other combination agents are identified.

Conditions

B-cell Malignancy

Relapsed Cancer

Refractory Cancer

B-cell Lymphoma

Study ID

NCT06634589

Start date

Nov 27, 2024

Status verified date

Aug, 2026

Completion date

Dec 2, 2029

Anticipated

Primary completion date

Dec 2, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

80 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Substudy 1 Part 1a: Dose Escalation

Sequential cohorts of increasing dose level combinations of tacabrutideg and sonrotoclax will be evaluated in participants with selected B-cell malignancies.

experimental: Substudy 1 Part 1b: Safety Expansion

Cohorts of select dose level combinations of tacabrutideg and sonrotoclax will be evaluated in participants with selected B-cell malignancies.

experimental: Substudy 2 Part 1a: Dose Escalation

Sequential cohorts of increasing dose level combinations of tacabrutideg and zanubrutinib will be evaluated in participants with selected B-cell malignancies.

experimental: Substudy 2 Part 1b: Safety Expansion

Cohorts of select dose level combinations of tacabrutideg and zanubrutinib will be evaluated in participants with selected B-cell malignancies.

experimental: Substudy 3 Part 1a: Dose Escalation

Sequential cohorts of increasing dose level combinations of tacabrutideg and mosunetuzumab will be evaluated in participants with selected B-cell malignancies.

experimental: Substudy 3 Part 1b: Safety Expansion

Cohorts of select dose level combinations of tacabrutideg and mosunetuzumab will be evaluated in participants with selected B-cell malignancies.

experimental: Substudy 4 Part 1a: Dose Escalation

Sequential cohorts of increasing dose level combinations of tacabrutideg and glofitamab will be evaluated in participants with selected B-cell malignancies. Participants will receive obinutuzumab as pretreatment prior to the start of combination treatment.

experimental: Substudy 4 Part 1b: Safety Expansion

Cohorts of select dose level combinations of tacabrutideg and glofitamab will be evaluated in participants with selected B-cell malignancies.

Interventions

Tacabrutideg

Administered orally

Sonrotoclax

Administered orally

Zanubrutinib

Administered orally

Mosunetuzumab

Administered subcutaneously

Glofitamab

Administered intravenously

Obinutuzumab

Administered intravenously

Primary outcome measure

  • Substudy 1 Part 1a: Number of participants with dose-limiting toxicities (DLTs), treatment-emergent adverse events, treatment-related adverse events, and serious adverse events [ Time Frame: From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years ]
  • Substudy 1 Part 1b: Number of participants with treatment-emergent adverse events, treatment-related adverse events, and serious adverse events [ Time Frame: From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years ]
  • Substudy 2 Part 1a: Number of participants with dose-limiting toxicities (DLTs), treatment-emergent adverse events, treatment-related adverse events, and serious adverse events [ Time Frame: From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years ]
  • Substudy 2 Part 1b: Number of participants with treatment-emergent adverse events, treatment-related adverse events, and serious adverse events [ Time Frame: From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years ]
  • Substudy 3 Part 1a: Number of participants with dose-limiting toxicities (DLTs), treatment-emergent adverse events, treatment-related adverse events, and serious adverse events [ Time Frame: From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years ]
  • Substudy 3 Part 1b: Number of participants with treatment-emergent adverse events, treatment-related adverse events, and serious adverse events [ Time Frame: From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years] ]
  • Substudy 4 Part 1a: Number of participants with dose-limiting toxicities (DLTs), treatment-emergent adverse events, treatment-related adverse events, and serious adverse events [ Time Frame: From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years ]
  • Substudy 4 Part 1b: Number of participants with treatment-emergent adverse events, treatment-related adverse events, and serious adverse events [ Time Frame: From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years ]

Central Contacts and Locations

Central contacts

Study Director

1.877.828.5568clinicaltrials@beonemed.com

Locations

Mayo Clinic Phoenix

Recruiting

Phoenix, Arizona, United States, 85054-4502

University of Southern California Norris Comprehensive

Recruiting

Los Angeles, California, United States, 90033

Mayo Clinic Jacksonville

Recruiting

Jacksonville, Florida, United States, 32224-1865

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612-9496

The University of Kansas Cancer Center

Recruiting

Westwood, Kansas, United States, 66205-2003

Mayo Clinic Rochester

Recruiting

Rochester, Minnesota, United States, 55905-0001

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110-1010

Summit Medical Group

Recruiting

Florham Park, New Jersey, United States, 07932-1049

Icahn School of Medicine At Mount Sinai

Recruiting

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

Columbia University Medical Center

Recruiting

New York, New York, United States, 10032

Weill Cornell Medical College Newyork Presbyterian Hospital

Recruiting

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

Memorial Sloan Kettering Cancer Center Mskcc

Recruiting

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

University of Rochester

Recruiting

Rochester, New York, United States, 14642-0001

Fox Chase Cancer Center

Recruiting

Philadelphia, Pennsylvania, United States, 19111-2434

The University of Texas Md Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030-4009

Huntsman Cancer Institute

Recruiting

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

University of Wisconsin

Recruiting

Madison, Wisconsin, United States, 53792-0001

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226-3522

More Information

Sponsor

BeOne Medicines

Last update posted

Aug 21, 2026

Last verified

Aug, 2026

Keywords

  • R/R B-Cell Malignancies
  • relapsed or refractory B-Cell Malignancies
  • B-Cell malignancy
  • BGB-16673
  • sonrotoclax
  • zanubrutinib
  • B-cell lymphoma
  • Bruton Tyrosine Kinase (BTK)
  • Mosunetuzumab
  • Glofitamab
  • tacabrutideg

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by BeOne Medicines on 2026-08-21.