Trial purpose
Cancer treatment
Tumor type
Haematological
Age
18+
Clinical summary
Summary
The purpose of this study is to measure how safe and helpful a targeted therapy drug called BGB-16673 when given in combination with other targeted medicines. BGB-16673 is a drug that targets and damages Bruton's tyrosine kinase (BTK), which helps stop the growth of cancerous B-cells that overexpress BTK.
This study is structured as a master protocol with separate substudies to test different medicine combinations. This study will currently includes four substudies, and more substudies may be added as they become available.
- Substudy 1: BGB-16673 with sonrotoclax
- Substudy 2: BGB-16673 with zanubrutinib
- Substudy 3: BGB-16673 with mosunetuzumab
- Substudy 4: BGB-16673 with glofitamab
Conditions
This trial is treating people with B-cell malignancies that have either come back (relapsed) or not responded to (refractory) prior treatment
Eligibility
Inclusion
- 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
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Substudies 1, 3, and 4 Inclusion Criterion:
- Adequate renal function as indicated by estimated glomerular filtration rate (eGFR) of ≥ 50 mL/min
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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
- 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
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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)
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Substudy 2 Exclusion Criterion:
- Participants who discontinued prior zanubrutinib treatment due to intolerance
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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.
Inclusion
- You have had treatment, but your cancer has come back (relapsed or recurrent).
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
- You are able to swallow medication by mouth.
- You have had a certain type of treatment or surgical procedure.
Exclusion
- You have been diagnosed with a prior or secondary type of cancer.
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov, EU Clinical Trials Register *. View further details about this trial on the registry via the links below:
Trial sponsor
BeiGene
Scientific Title
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
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