A Study to Investigate Safety and Effectiveness of BGB-16673 in Combination With Other Agents in Participants With Relapsed or Refractory B-Cell Malignancies

Purpose

The purpose of this study is to measure the safety, preliminary antitumor activity, pharmacokinetics, and pharmacodynamics with BGB-16673 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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 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 sonrotoclax or 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 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 sonrotoclax or 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

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 - 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 Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Substudy 1 Part 1a: Dose Escalation 		Sequential cohorts of increasing dose level combinations of BGB-16673 and sonrotoclax will be evaluated in participants with selected B-cell malignancies.
  • Drug: BGB-16673
    Administered orally
  • Drug: Sonrotoclax
    Administered orally
    Other names:
    • BGB-11417
Experimental
Substudy 1 Part 1b: Safety Expansion 		Cohorts of select dose level combinations of BGB-16673 and sonrotoclax will be evaluated in participants with selected B-cell malignancies.
  • Drug: BGB-16673
    Administered orally
  • Drug: Sonrotoclax
    Administered orally
    Other names:
    • BGB-11417
Experimental
Substudy 2 Part 1a: Dose Escalation 		Sequential cohorts of increasing dose level combinations of BGB-16673 and zanubrutinib will be evaluated in participants with selected B-cell malignancies.
  • Drug: BGB-16673
    Administered orally
  • Drug: Zanubrutinib
    Administered orally
Experimental
Substudy 2 Part 1b: Safety Expansion 		Cohorts of select dose level combinations of BGB-16673 and zanubrutinib will be evaluated in participants with selected B-cell malignancies.
  • Drug: BGB-16673
    Administered orally
  • Drug: Zanubrutinib
    Administered orally
Experimental
Substudy 3 Part 1a: Dose Escalation 		Sequential cohorts of increasing dose level combinations of BGB-16673 and mosunetuzumab will be evaluated in participants with selected B-cell malignancies.
  • Drug: BGB-16673
    Administered orally
  • Drug: Mosunetuzumab
    Administered subcutaneously
Experimental
Substudy 3 Part 1b: Safety Expansion 		Cohorts of select dose level combinations of BGB-16673 and mosunetuzumab will be evaluated in participants with selected B-cell malignancies.
  • Drug: BGB-16673
    Administered orally
  • Drug: Mosunetuzumab
    Administered subcutaneously
Experimental
Substudy 4 Part 1a: Dose Escalation 		Sequential cohorts of increasing dose level combinations of BGB-16673 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.
  • Drug: BGB-16673
    Administered orally
  • Drug: Glofitamab
    Administered intravenously
  • Drug: Obinutuzumab
    Administered intravenously
Experimental
Substudy 4 Part 1b: Safety Expansion 		Cohorts of select dose level combinations of BGB-16673 and glofitamab will be evaluated in participants with selected B-cell malignancies.
  • Drug: BGB-16673
    Administered orally
  • Drug: Glofitamab
    Administered intravenously
  • Drug: Obinutuzumab
    Administered intravenously

Recruiting Locations

Mayo Clinic Phoenix
Phoenix 5308655, Arizona 5551752 85054-4502

University of Southern Californianorris Comprehensive
Los Angeles 5368361, California 5332921 90033

Mayo Clinic Jacksonville
Jacksonville 4160021, Florida 4155751 32224-1865

Moffitt Cancer Center
Tampa 4174757, Florida 4155751 33612-9496

The University of Kansas Cancer Center
Westwood 4281639, Kansas 4273857 66205-2003

Mayo Clinic Rochester
Rochester 5043473, Minnesota 5037779 55905-0001

Washington University School of Medicine
St Louis 4407066, Missouri 4398678 63110-1010

Summit Medical Group
Florham Park 5098095, New Jersey 5101760 07932-1049

Icahn School of Medicine At Mount Sinai
New York 5128581, New York 5128638 10029-6504

Weill Cornell Medical College Newyork Presbyterian Hospital
New York 5128581, New York 5128638 10065-4870

Memorial Sloan Kettering Cancer Center Mskcc
New York 5128581, New York 5128638 10065-6800

University of Rochester
Rochester 5134086, New York 5128638 14642-0001

Fox Chase Cancer Center
Philadelphia 4560349, Pennsylvania 6254927 19111-2434

The University of Texas Md Anderson Cancer Center
Houston 4699066, Texas 4736286 77030-4009

Huntsman Cancer Institute
Salt Lake City 5780993, Utah 5549030 84112-5550

University of Wisconsin
Madison 5261457, Wisconsin 5279468 53792-0001

Medical College of Wisconsin
Milwaukee 5263045, Wisconsin 5279468 53226-1222

More Details

NCT ID
NCT06634589
Status
Recruiting
Sponsor
BeOne Medicines

Study Contact

Study Director
1.877.828.5568
clinicaltrials@beonemed.com

Detailed Description

This new study will check how safe and helpful a potential anticancer drug called BGB-16673 is in participants with R/R B-cell malignancies when it is given in combination with other medicines - sonrotoclax in substudy 1, zanubrutinib in substudy 2, mosunetuzumab in substudy 3, and glofitamab in substudy 4. 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.

For help using this page: trialstoday@researchmatch.org or call 855-514-7001

ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center