Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BGB-3111 · 4 trials · 3 indications
Percentage of participants with CR, defined as normal serum immunoglobulin M (IgM) levels, disappearance of monoclonal protein by immunofixation, and negative cryoglobulinemia if cryoglobulinemia was positive at baseline, or VGPR, defined as ≥90% reduction in serum IgM level from baseline or normal serum IgM values.
Incidence of treatment-emergent adverse events reported for zanubrutinib compared with placebo
Evaluate the effects of single doses of zanubrutinib on the corrected QT interval \[QTc\] using the Fridericia correction \[QTcF\]) compared with placebo
Urine and fecal collection for Mass Balance Evaluation
Urine and fecal collection for Metabolite Profiling/Characterization
| Arm | Type | Description |
|---|---|---|
| Arm A : Ibrutinib | EXPERIMENTAL | Participants with the MYD88 mutation received Ibrutinib |
| Arm B: Zanubrutinib | ACTIVE_COMPARATOR | Participants with the MYD88 mutation received zanubrutinib |
| Part A: BGB-3111 | EXPERIMENTAL | - |
| Part A: Placebo | PLACEBO_COMPARATOR | - |
| Part B: BGB-3111, Placebo, and Moxifloxicin | EXPERIMENTAL | - |
| Arm A | EXPERIMENTAL | Approximately 20 subjects to receive BGB-3111 and rifampin |
| Arm B | EXPERIMENTAL | Approximately 20 subjects to receive BGB-3111 and itraconazole |
| Name | Type | Description |
|---|---|---|
| BGB-3111 | DRUG | 160 mg PO BID until progressive disease, unacceptable toxicity, death, withdrawal of consent, or study termination by sponsor |
| Ibrutinib | DRUG | 420 mg PO QD until progressive disease, unacceptable toxicity, death, withdrawal of consent, or study termination by sponsor |
| Placebo | DRUG | Subjects will receive Placebo |
| Moxifloxacin | DRUG | Subjects will receive Moxifloxicin |
| BGB-3111 (Arm A) | DRUG | 320 mg BGB-3111 single oral dose |
| Rifampin | DRUG | 600 mg rifampin once daily |
| BGB-3111 (Arm B) | DRUG | Up to 80 mg BGB-3111 single oral dose |
| Itraconazole | DRUG | 200 mg itraconazole once daily |
| [14C]-BGB-3111 | DRUG | 20-mg capsule containing \~200 μCi of \[14C\]-BGB-3111, |
Key Inclusion Criteria: * Clinical and definitive histologic diagnosis of WM * Measurable disease, requiring treatment * Participants with no prior therapy for WM, must be considered inappropriate candidates for treatment with a standard chemoimmunotherapy regimen * Age ≥ 18 years old * Eastern Coo...
BGB-3111, also known as zanubrutinib, is an investigational small molecule being studied for Waldenström's Macroglobulinemia, a rare type of non-Hodgkin lymphoma. It has also been evaluated in healthy volunteers for pharmacokinetic studies. The drug is currently in clinical development and is not yet approved for any indication.
BGB-3111 targets Bruton's tyrosine kinase (BTK), an enzyme involved in B-cell development and signaling. By inhibiting BTK, the drug aims to disrupt the growth and survival of malignant B-cells, which is relevant in Waldenström's Macroglobulinemia. This mechanism is being investigated in clinical trials.
BGB-3111 is being developed by BeOne Medicines Ltd., a biopharmaceutical company listed on the stock exchange under the ticker symbol ONC. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Waldenström's Macroglobulinemia and in healthy subjects.
BGB-3111 is in Phase 1 clinical development. While a Phase 3 trial comparing BGB-3111 to ibrutinib in Waldenström's Macroglobulinemia has been completed, the drug remains investigational and has not received FDA approval. All trials listed for BGB-3111 are completed, with no active trials currently ongoing.
BGB-3111 has been studied in several completed clinical trials, including NCT03053440, a Phase 3 study comparing BGB-3111 to ibrutinib in 201 participants with Waldenström's Macroglobulinemia. Other trials include NCT03301181, NCT03432884, and NCT04163783, which were Phase 1 studies in healthy volunteers to assess drug interactions, cardiac effects, and metabolism.
Yes, BGB-3111 is also known as zanubrutinib. In clinical trials, the drug is referred to by both names, with zanubrutinib being the generic name used in study titles. This alternative name is important for identifying the drug in medical literature and regulatory documents.