At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Tacabrutideg (drug)
- How long the study runs
- Study runs about 102 months (dates as stated)
- About the drug or intervention
- Tacabrutideg — drug: Orally administered
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 689
- Started
- 2021-09-13
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for b-cell malignancy
- • Phase1/Phase2 - 689 participants
- • Study consists of two main parts to explore tacabrutideg recommended dosing, a Phase 1 monotherapy dose finding comprised of monotherapy dose escalation and monotherapy safety expansion of selected doses, and a Phase 2 (expansion cohorts)
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with b-cell malignancy
Where?
- • Edinburgh - Edinburgh Cancer Centre
- • Leeds - St Jamess University Hospital
- • Newcastle upon Tyne - Freeman Hospital
- • Newmarket - Genesiscare Cambridge
- • +3 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
Study consists of two main parts to explore tacabrutideg recommended dosing, a Phase 1 monotherapy dose finding comprised of monotherapy dose escalation and monotherapy safety expansion of selected doses, and a Phase 2 (expansion cohorts)
More detail
A B-cell malignancy is a type of cancer that starts in white blood cells called B-cells. These cancers can affect the lymph nodes, bone marrow, blood, spleen, and other organs. Examples of these cancers include chronic lymphocytic leukemia/small lymphocytic lymphoma, marginal zone lymphoma, follicular lymphoma, Waldenström macroglobulinemia, mantle cell lymphoma, and diffuse large B cell lymphoma. Tacabrutideg is a type of medicine called a BTK degrader. BTK (Bruton's tyrosine kinase) is a protein that helps cancer cells survive. Tacabrutideg is designed to attach to the BTK protein and tag it for removal, so that the body's own cellular "clean-up" system breaks it down and clears it away. When more BTK is removed from the body, it interferes with the signals needed for the cancer cells to multiply and survive and may also reduce the chance of the cancer becoming resistant to treatment. The purpose of this study is to test whether tacabrutideg is safe and if it can treat B-cell malignancies. The main goals are to ensure the drug is safe by monitoring side effects and to understand how well patients respond to the treatment and whether their cancers shrink or disappear. This study consists of two parts: dose escalation and dose expansion. During the dose escalation part, the study doctors will test different doses of the study drug to find the recommended dose that people can take without having serious side effects. During the dose expansion part, the study doctors will test the study drug in a larger number of people using the dose or doses identified from dose escalation. The study is open label, which means that the participants and the study doctors will know what treatment is received. This study will enroll approximately 689 participants with B-cell malignancies at multiple centers worldwide. The overall time to participate in this study is approximately 3 years. Participants will make regular visits to the clinic for treatment, health checks, blood tests, and tumor and imaging tests. 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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
Who cannot take part
- ✗Requires ongoing systemic treatment for any other cancer
- ✗Requires ongoing systemic (defined as ≥ 10 mg/day of prednisone or equivalent) corticosteroid treatment.
- ✗Note: Other protocol defined Inclusion/Exclusion criteria may apply.
See the full criteria
Where Is This Study? (7 UK sites)
Edinburgh Cancer Centre
Edinburgh EH4 2XU, United Kingdom
St Jamess University Hospital
Leeds LS9 7TF, United Kingdom
Freeman Hospital
Newcastle upon Tyne NE7 7DN, United Kingdom
Genesiscare Cambridge
Newmarket CB8 7XN, United Kingdom
Norfolk and Norwich University Hospitals Nhs Foundation Trust
Norwich NR4 7UY, United Kingdom
Nottingham University Hospitals Nhs Trust
Nottingham NG5 1PB, United Kingdom
Derriford Hospital
Plymouth PL6 8DH, United Kingdom
How to Get in Touch
BeOne Medicines
Sponsor contactCONTACT
Study Director, MD
Sponsor contactCONTACT
