Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BGB-16673 · 5 trials · 13 indications
PFS is defined as time from the date of randomization to the date of first disease progression or death, whichever occurs first, as determined by IRC using modified 2018 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria for participants with R/R CLL and the Lugano Classification for patients with R/R SLL.
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including findings from laboratory tests and electrocardiogram results.
Number of participants with TEAEs and SAEs, including findings from laboratory tests and electrocardiogram results.
Number of participants with AEs and SAEs as graded by the National Cancer Institute- Common Terminology Criteria for Adverse Events Version 5 (NCI CTCAE 5.0), including AEs that meet protocol-defined dose-limiting toxicity (DLT) criteria.
As determined by the sponsor based on the Safety Monitoring Committee's recommendation considering totality of the available clinical safety, clinical efficacy, pharmacokinetics, and pharmacodynamics data.
The highest dose evaluated as recommended by the Bayesian Optimal Interval Design with Informative Prior (iBOIN) design or the maximum assessed dose (MAD).
ORR is defined as the percentage of participants with partial response or better according to the Independent Review Committee (IRC) assessment and as determined by Lugano criteria.
ORR is defined as the percentage of participants with partial response or better as assessed by the IRC and determined by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria for CLL and by Lugano criteria for SLL
| Arm | Type | Description |
|---|---|---|
| Arm A: BGB-16673 Monotherapy | EXPERIMENTAL | Participants will receive BGB-16673 once daily until any of the treatment discontinuation criteria are met |
| Arm B: Investigator's Choice | ACTIVE_COMPARATOR | Participants will receive investigator's choice of bendamustine plus rituximab or high-dose methylprednisolone plus rituximab or chlorambucil plus obinutuzumab for up to six 28-day cycles. Participants with unequivocal disease progression confirmed by Independent Review Committee (IRC) may cross over to receive treatment with BGB-16673 at the Investigator's discretion |
| Part A (CSU): Tacabrutideg | EXPERIMENTAL | Sequential cohorts of increasing dose levels of tacabrutideg will be evaluated in participants with CSU. |
| Part A (CSU): Placebo | PLACEBO_COMPARATOR | Participants with CSU will receive matching placebo orally for 28 days and then crossover to receive tacabrutideg. |
| Part B (Healthy Participants): Tacabrutideg | EXPERIMENTAL | Sequential cohorts of increasing dose levels of tacabrutideg will be evaluated in healthy participants. |
| Part A: BGB-16673 + Phenytoin (CYP3A Inducer) | EXPERIMENTAL | Participants will receive multiple doses of Phenytoin to determine its effect on BGB-16673 |
| Part B: BGB-16673 + Itraconazole (CYP3A Inhibitor) | EXPERIMENTAL | Participants will receive multiple doses of Itraconazole to determine its effect on BGB-16673 |
| Single Arm: [14C]-BGB-16673 | EXPERIMENTAL | Participants will receive a single dose of \[14C\]-BGB-16673 |
| Phase 1a Monotherapy Dose Escalation | EXPERIMENTAL | BGB-16673 will be orally administered. |
| Phase 1b Monotherapy Safety Expansion | EXPERIMENTAL | BGB-16673 will be orally administered. |
| Phase 2 Monotherapy Dose Expansion | EXPERIMENTAL | BGB-16673 will be administered at the recommended Phase 2 dose (RP2D) that was identified in Part 1. |
| Name | Type | Description |
|---|---|---|
| BGB-16673 | DRUG | Administered orally |
| Bendamustine | DRUG | Administered intravenously |
| Rituximab | DRUG | Administered intravenously |
| Methylprednisolone | DRUG | Administered intravenously |
| Chlorambucil | DRUG | Administered orally |
| Obinutuzumab | DRUG | Administered intravenously |
| Tacabrutideg | DRUG | Administered orally |
| Placebo | DRUG | Administered orally |
| Itraconazole | DRUG | Administered orally |
| Phenytoin | DRUG | Administered orally |
| [14C]-BGB-16673 | DRUG | Administered orally as suspension in lipid vehicle |
Inclusion Criteria: 1. Confirmed diagnosis of CLL/SLL, requiring treatment, based on 2018 international workshop on chronic lymphocytic leukemia (iwCLL) criteria. 2. Previously received treatment for CLL/SLL with a covalent BTKi. 3. Measurable disease by computer tomography/magnetic resonance imagi...
BGB-16673 is an investigational small molecule being studied for B-cell malignancies including chronic lymphocytic leukemia, mantle cell lymphoma, Waldenström macroglobulinemia, and Richter's transformation, as well as for chronic spontaneous urticaria. It is also being evaluated in healthy volunteers for pharmacokinetic studies. The drug is in Phase 1 clinical development.
BGB-16673 targets Bruton tyrosine kinase (BTK), a kinase involved in B-cell signaling. It is designed as a BTK-targeted protein degrader, meaning it works by degrading the BTK protein rather than simply inhibiting its activity. This mechanism is being studied in B-cell malignancies and chronic spontaneous urticaria.
BGB-16673 is being developed by BeOne Medicines Ltd., a biopharmaceutical company listed under the ticker ONC. The company is conducting Phase 1 clinical trials of this investigational small molecule across multiple indications, including oncology and immunology.
BGB-16673 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 program includes trials in patients with B-cell malignancies, healthy volunteers for drug metabolism studies, and adults with chronic spontaneous urticaria.
BGB-16673 is being studied in four Phase 1 trials. NCT05294731 is recruiting patients with B-cell malignancies in China. NCT06776679 and NCT06906809, both completed, examined drug absorption and metabolism in healthy volunteers in the United States. NCT07005713 is evaluating multiple ascending doses in chronic spontaneous urticaria.
Yes, BGB-16673 is being studied in chronic spontaneous urticaria. Trial NCT07005713 is a Phase 1 study evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple ascending doses of BGB-16673 in adults with this condition. The trial is active but not recruiting, with an enrollment of 34 participants in China.