A Phase 1/2 interventional study of Tacabrutideg and Sonrotoclax in B-cell Malignancy, Relapsed Cancer and Refractory Cancer, sponsored by BeOne Medicines. Recruiting at 49 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by BeOne Medicines · Phase 1/2, Interventional, and Treatment
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.
This new study will check how safe and helpful a potential anticancer drug called tacabrutideg 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.
885 studies on the registry are indexed under Lymphoma, B-Cell; 286 are open to participants now.
This study's planned enrollment of 80 is above the median of 34 across 773 interventional studies indexed under Lymphoma, B-Cell.
Browse Lymphoma, B-Cell studies →BeOne Medicines is the lead sponsor of 68 studies on the registry; 48 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Compared within Lymphoma, B-Cell, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Recurrence. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Key Inclusion Criteria:
Substudies 1, 3, and 4 Inclusion Criterion:
Substudy 2 Inclusion Criteria:
Key Exclusion Criteria:
Substudy 1 Exclusion Criterion:
Substudy 2 Exclusion Criterion:
Substudies 3 and 4 Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Leptomeningeal disease
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GVHD (graft-versus-host disease)
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Sequential cohorts of increasing dose level combinations of tacabrutideg and sonrotoclax will be evaluated in participants with selected B-cell malignancies.
Drug: Tacabrutideg · Drug: Sonrotoclax
Cohorts of select dose level combinations of tacabrutideg and sonrotoclax will be evaluated in participants with selected B-cell malignancies.
Drug: Tacabrutideg · Drug: Sonrotoclax
Sequential cohorts of increasing dose level combinations of tacabrutideg and zanubrutinib will be evaluated in participants with selected B-cell malignancies.
Drug: Tacabrutideg · Drug: Zanubrutinib
Cohorts of select dose level combinations of tacabrutideg and zanubrutinib will be evaluated in participants with selected B-cell malignancies.
Drug: Tacabrutideg · Drug: Zanubrutinib
Sequential cohorts of increasing dose level combinations of tacabrutideg and mosunetuzumab will be evaluated in participants with selected B-cell malignancies.
Drug: Tacabrutideg · Drug: Mosunetuzumab
Cohorts of select dose level combinations of tacabrutideg and mosunetuzumab will be evaluated in participants with selected B-cell malignancies.
Drug: Tacabrutideg · Drug: Mosunetuzumab
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.
Drug: Tacabrutideg · Drug: Glofitamab · Drug: Obinutuzumab
Cohorts of select dose level combinations of tacabrutideg and glofitamab will be evaluated in participants with selected B-cell malignancies.
Drug: Tacabrutideg · Drug: Glofitamab · Drug: Obinutuzumab
Administered orally
Also known as: BGB-16673
Administered orally
Also known as: BGB-11417
Administered orally
Administered subcutaneously
Administered intravenously
Administered intravenously
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
Substudy 1 Parts 1a and 1b: Overall Response Rate (ORR) in participants with B-cell malignancies
ORR is defined as the percentage of participants with complete response (CR) or partial response (PR) as assessed by investigator.
Time frame: Up to approximately 3 years
Substudy 1 Parts 1a and 1b: Duration of Response (DOR)
DOR is defined as the time from the first documented response to documented disease progression or death, whichever occurs first.
Time frame: Up to approximately 3 years
Substudy 1 Parts 1a and 1b: Time to Response (TTR)
TTR is defined as the time from treatment initiation to first documented response.
Time frame: Up to approximately 3 years
Substudy 1 Part 1a: Area under the plasma concentration-time curve (AUC) of tacabrutideg and sonrotoclax
Time frame: From Week 1 to Week 17
Substudy 1 Part 1a: Maximum observed concentration (Cmax) of tacabrutideg and sonrotoclax
Time frame: From Week 1 to Week 17
Substudy 1 Part 1a: Time to maximum concentration (Tmax) of tacabrutideg and sonrotoclax
Time frame: From Week 1 to Week 17
Substudy 1 Part 1a: Terminal half-life (t1/2) of tacabrutideg and sonrotoclax
Time frame: From Week 1 to Week 17
Substudy 1 Parts 1a and 1b: Trough concentration (Ctrough) of tacabrutideg and sonrotoclax
Time frame: From Week 1 to Week 17
Substudy 1 Part 1b: Number of patients with complete response or complete response with incomplete count recovery (CR/CRi) who achieve undetectable minimal residual disease (uMRD)
Time frame: Up to approximately 3 years
Substudy 2 Parts 1a and 1b: ORR in participants with B-cell malignancies
ORR is defined as the percentage of participants with complete response (CR) or partial response (PR) as assessed by the investigator.
Time frame: Up to approximately 3 years
Substudy 2 Parts 1a and 1b: DOR
DOR is defined as the time from the first documented response to documented disease progression or death, whichever occurs first.
Time frame: Up to approximately 3 years
Substudy 2 Parts 1a and 1b: TTR
TTR is defined as the time from treatment initiation to the first documented response.
Time frame: Up to approximately 3 years
Substudy 2 Part 1a: Area under the plasma concentration-time curve (AUC) of tacabrutideg and zanubrutinib
Time frame: From Week 1 to Week 17
Substudy 2 Part 1a: Maximum observed concentration (Cmax) of tacabrutideg and zanubrutinib
Time frame: From Week 1 to Week 17
Substudy 2 Part 1a: Time to maximum concentration (Tmax) of tacabrutideg and zanubrutinib
Time frame: From Week 1 to Week 17
Substudy 2 Part 1a: Terminal half-life (t1/2) of tacabrutideg and zanubrutinib
Time frame: From Week 1 to Week 17
Substudy 2 Parts 1a and 1b: Trough concentration (Ctrough) of tacabrutideg and zanubrutinib
Time frame: From Week 1 to Week 17 for Part 1a; From Week 1 to Week 5 for Part 1b
Substudy 3 Parts 1a and 1b: ORR in participants with B-cell malignancies
ORR is defined as the percentage of participants with complete response (CR) or partial response (PR) as assessed by the investigator.
Time frame: Up to approximately 3 years
Substudy 3 Parts 1a and 1b: DOR
DOR is defined as the time from the first documented response to documented disease progression or death, whichever occurs first.
Time frame: Up to approximately 3 years
Substudy 3 Parts 1a and 1b: TTR
TTR is defined as the time from treatment initiation to the first documented response.
Time frame: Up to approximately 3 years
Substudy 3 Part 1a: Area under the plasma concentration-time curve (AUC) of tacabrutideg and mosunetuzumab
Time frame: From Week 1 to Week 12
Substudy 3 Part 1a: Maximum observed concentration (Cmax) of tacabrutideg and mosunetuzumab
Time frame: From Week 1 to Week 12
Substudy 3 Part 1a: Time to maximum concentration (Tmax) of tacabrutideg and mosunetuzumab
Time frame: From Week 1 to Week 12
Substudy 3 Part 1a: Terminal half-life (t1/2) of tacabrutideg and mosunetuzumab
Time frame: From Week 1 to Week 12
Substudy 3 Parts 1a and 1b: Trough concentration (Ctrough) of tacabrutideg and mosunetuzumab
Time frame: From Week 1 to Week 36
Substudy 4 Parts 1a and 1b: ORR in participants with B-cell malignancies
ORR is defined as the percentage of participants with partial response (PR) or better as assessed by the investigator.
Time frame: Up to approximately 3 years
Substudy 4 Parts 1a and 1b: DOR
DOR is defined as the time from the first documented response to documented disease progression or death, whichever occurs first.
Time frame: Up to approximately 3 years
Substudy 4 Parts 1a and 1b: TTR
TTR is defined as the time from treatment initiation to the first documented response.
Time frame: Up to approximately 3 years
Substudy 4 Part 1a: Area under the plasma concentration-time curve (AUC) of tacabrutideg
Time frame: From Week 1 to Week 10
Substudy 4 Part 1a: Maximum observed concentration (Cmax) of tacabrutideg
Time frame: From Week 1 to Week 10
Substudy 4 Part 1a: Time to maximum concentration (Tmax) of tacabrutideg
Time frame: From Week 1 to Week 10
Substudy 4 Part 1a: Terminal half-life (t1/2) of tacabrutideg
Time frame: From Week 1 to Week 10
Substudy 4 Parts 1a and 1b: Trough concentration (Ctrough) of tacabrutideg
Time frame: From Week 1 to Week 10
Plan to share: Yes — BeOne shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved. BeOne shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations. Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: See plan description
Access criteria: See plan description
Data sharing details ↗ · beonemedicines.com
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