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A Study to Investigate Safety and Effectiveness of BGB-16673 in Combination With Other Agents in Patients With Relapsed or Refractory B-Cell Malignancies
EU CTIS ID: 2024-516234-35-00
What this study is testing
- To evaluate safety and tolerability of and identify the recommended dose(s) for expansion (RDFE(s)) for BGB-16673 combination treatments in patients with selected relapsed/refractory (R/R) B-cell malignancies (Part 1a) - To characterize the safety and tolerability of BGB-16673 combination treatments at the RDFE(s) and RP2D(s) in patients with selected B-cell malignancies (Part 1b)
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
- Adequate renal function as indicated by eGFR of ≥ 30 mL/min (Sub-study 2)
- Confirmed diagnosis of a R/R B-cell malignancy
- Protocol-defined measurable disease
- Stable Eastern Cooperative Oncology Group Performance Status of 0 to 1
- Adequate organ function
You likely can't join if
- Treatment-naive B-cell malignancies, except for patients in Substudy 1 Cohorts 5 and 6.
- Prior exposure to a CD20 x CD3 T-cell engager antibody treatment (Sub-studies 3 and 4)
- All participants with a prior allogeneic stem cell transplant (Sub-studies 3 and 4)
- 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 and any locally recurring cancer that has been treated curatively
See the full eligibility 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
- Adequate renal function as indicated by eGFR of ≥ 30 mL/min (Sub-study 2)
- Confirmed diagnosis of a R/R B-cell malignancy
- Protocol-defined measurable disease
- Stable Eastern Cooperative Oncology Group Performance Status of 0 to 1
- 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, or 90 days after the last dose of sonrotoclax, 3 months after the last dose of mosunetuzumab or tocilizumab, 18 months after pretreatment with obinutuzumab, 2 months after the last dose of glofitamab. 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, 90 days after the last dose of sonrotoclax, 3 months after the last dose of mosunetuzumab or tocilizumab, 18 months after pretreatment with obinutuzumab, 2 months after the last dose of glofitamab
- Adequate renal function as indicated by estimated glomerular filtration rate (eGFR) of ≥ 50 mL/min (Sub-studies 1, 3 and 4)
- Bruton tyrosine kinase (BTK) inhibitor-naive, or previously received treatment with a covalent BTK inhibitor and discontinued for reasons other than clinical progression (Sub-study 2)
- Treatment-naive B-cell malignancies, except for patients in Substudy 1 Cohorts 5 and 6.
- Prior exposure to a CD20 x CD3 T-cell engager antibody treatment (Sub-studies 3 and 4)
- All participants with a prior allogeneic stem cell transplant (Sub-studies 3 and 4)
- 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 and 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 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 (Sub-studies 1 and 2)
- 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
- 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) (Sub-study 1)
- Participants who discontinued prior zanubrutinib treatment due to intolerance (Sub-study 2)
The study team makes the final eligibility decision.
Where it's taking place
- China
- Brazil
- New Zealand
- United States
- Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include China; Brazil; New Zealand; United States; Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.