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Also known as Zanubrutinib, zanubrutinib, Zanubrutinib Oral Capsule
zanubrutinib+ BGB-11417 · 1 trial · 1 indication
Number of subjects achieving a CR or VGPR at any time during the course of treatment
| Arm | Type | Description |
|---|---|---|
| Zanubrutinb + BGB-11417 | EXPERIMENTAL | cf intervention |
| Name | Type | Description |
|---|---|---|
| zanubrutinib + BGB-11417 | DRUG | The investigational medicinal products (IMP) are Zanubrutinib (BGB- 3111) and BGB-11417.Treatment will be administered for a total of twenty 28 day cycles: Cycle 1 with zanubrutinib only Cycle 2 with zanubrutinib plus BGB-11417 ramp-up cycle 2, day 1 : 10mg cycle 2, day 2 : 20 mg cycle 2, day 3 : 40mg cycle 2, day 4-7 : 80md daily cycle 2, day 8 and beyond : 160 mg daily Cycles 3-20 with zanubrutinib plus BGB-11417 full dose |
Inclusion Criteria: 1. Be ≥ 18-year-old. 2. Have received at least 1 prior line of treatment (excluding treatment with any BTKi or Bcl-2 antagonist, see non-inclusion criteria). 3. Provide written informed consent. 4. Have an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3. 5. Have...
Zanubrutinib is an investigational small molecule BTK inhibitor being studied for several B-cell malignancies, including relapsed/refractory diffuse large B-cell lymphoma, CNS lymphoma, mantle cell lymphoma, and refractory mantle cell lymphoma. It is also being evaluated in healthy volunteers. The drug is in Phase 1 clinical development.
Zanubrutinib targets Bruton's tyrosine kinase (BTK), an enzyme involved in B-cell receptor signaling. By inhibiting BTK, the drug aims to disrupt pathways that support the survival and proliferation of malignant B cells. This mechanism is relevant to the drug's evaluation in B-cell lymphomas and other conditions.
Zanubrutinib is being developed by BeOne Medicines Ltd., a company listed under the ticker ONC. The drug is currently in Phase 1 clinical trials, with multiple completed studies in various lymphoma subtypes and lupus nephritis.
Zanubrutinib is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The development program includes completed Phase 2 studies in follicular lymphoma, marginal zone lymphoma, diffuse large B-cell lymphoma, and lupus nephritis.
Zanubrutinib has been studied in several clinical trials, including NCT03332017 comparing obinutuzumab plus zanubrutinib versus obinutuzumab alone in relapsed/refractory follicular lymphoma, NCT03520920 in Chinese participants with diffuse large B-cell lymphoma and indolent lymphomas, NCT03846427 in marginal zone lymphoma, and NCT04643470 in lupus nephritis.
Yes, Zanubrutinib is also known as BGB-3111. The drug has been referred to by this alternative name in clinical trial documentation. It is also known as Zanubrutinib Oral Capsule in some contexts.