Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BGB-11417 · 5 trials · 13 indications
Defined as the proportion of participants who achieved a complete response (CR), complete remission with incomplete marrow recovery (CRi), nodular partial response (nPR), or partial response (PR) per the 2018 iwCLL guidelines for participants with chronic lymphocytic leukemia (CLL) or Defined as the proportion of participants who achieved PR or better per the Lugano Classification for partiticpants with small lymphocytic lymphoma (SLL)
Defined as the proportion of participants who achieved a complete response (CR), or partial response (PR) per the Lugano Classification
The RP2D will be decided by the sponsor and based on the safety monitoring committee recommendation considering totality of data.
All AEs, including DLT events, will be assessed per National Cancer Institute Common Terminology Criteria for Adverse Events v5.0 (or the Grading Scale for Hematologic Toxicity in CLL Studies as appropriate).
CR plus CRh will be defined as the percentage of participants whose best overall response (BOR) is CR plus CRh. BOR will be defined as the best response recorded from the first dose of study drug until data cut or the initiation of new anticancer treatment.
The mOR will be defined as the percentage of participants whose BOR is achieving CR, marrow complete remission (mCR), or partial remission (PR) at any time point during the study for myelodysplastic/myeloproliferative neoplasm (MDS/MPN).
| Arm | Type | Description |
|---|---|---|
| Treatment Arm | EXPERIMENTAL | Participants will receive BGB-11417 orally until disease progression, intolerable toxicity, or other scenarios specified in the protocol |
| [14C] radiolabeled BGB-11417 | EXPERIMENTAL | Participants will receive a single dose of \[14C\]-BGB-11417 |
| Single Arm | EXPERIMENTAL | Participants will receive sonrotoclax |
| Cohort A: R/R NHL | EXPERIMENTAL | Participants with R/R NHL, including follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL), marginal zone lymphoma (MZL), or transformed NHL, will receive oral BGB-11417 until the MTD (or maximum ascending dose \[MAD\]) and the RP2D can be determined. |
| Cohort B: R/R CLL/SLL (low tumor burden) | EXPERIMENTAL | Participants with low tumor burden R/R CLL/SLL will receive oral BGB-11417 until the MTD (or MAD) and the RP2D can be determined. |
| Cohort C: R/R CLL/SLL (high tumor burden) | EXPERIMENTAL | Participants in this cohort will not be enrolled until the RP2D for Cohort B is established. Participants will be treated with the monotherapy ramp-up schedule and the RP2D established in Cohort B. |
| Parts 1 and 2: AML Cohorts | EXPERIMENTAL | Participants with AML will receive BGB-11417 and azacitidine on a 28-day cycle. |
| Parts 1 and 2: MDS Cohorts | EXPERIMENTAL | Participants with MDS will receive BGB-11417 and azacitidine on a 28-day cycle. |
| Part 3: AML and MDS Cohorts | EXPERIMENTAL | Participants with AML and MDS will receive BGB-11417 and azacitidine on a 28-day cycle. A subset of the participants will receive a modified second cycle of treatment to explore drug-drug interactions (DDI) with posaconazole. |
| Part 3: AML and MDS Cohort | EXPERIMENTAL | Participants with MDS and R/R AML (China only) will receive BGB-11417 on a 28-day cycle. |
| Name | Type | Description |
|---|---|---|
| BGB-11417 | DRUG | Administered orally |
| [14C]-BGB-11417 | DRUG | A single oral dose of liquid formulation |
| Azacitidine | DRUG | Intravenous or subcutaneous administration for 7 days. |
| Posaconazole | DRUG | Oral administration for 8 days on second cycle only. |
Key Inclusion Criteria 1. Participants with a histologically confirmed diagnosis of CLL/SLL based on the International Workshop on CLL (iwCLL) criteria: 1. Treatment intolerance or failure during or after treatment with chemoimmunotherapy (CIT) and BTK inhibitors (BTKi) or 2. Treatment intol...
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BGB-11417 is an investigational small molecule being studied for the treatment of B-cell malignancies and myeloid cancers, including acute myeloid leukemia, mantle cell lymphoma, chronic lymphocytic leukemia, and small lymphocytic lymphoma. It is also being evaluated in healthy volunteers for pharmacokinetic studies. The drug is in clinical development and is not yet approved.
BGB-11417 targets BCL2, a protein that regulates apoptosis. By inhibiting BCL2, the drug is designed to promote cancer cell death. This mechanism is being investigated in several blood cancers, including acute myeloid leukemia and mantle cell lymphoma.
BGB-11417 is being developed by BeOne Medicines Ltd., a biopharmaceutical company listed on the stock exchange under the ticker ONC. The company is conducting multiple clinical trials to evaluate the drug's safety and efficacy in patients with hematologic malignancies.
BGB-11417 is in Phase 1 and Phase 2 clinical trials. The Phase 1 studies are evaluating the drug in myeloid malignancies, mantle cell lymphoma, and healthy volunteers, while a Phase 2 study is ongoing in China for relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.
BGB-11417 is being studied in several trials, including NCT04771130 for myeloid malignancies, NCT05471843 for relapsed or refractory mantle cell lymphoma, NCT05479994 for chronic lymphocytic leukemia or small lymphocytic lymphoma, and NCT05844111 in healthy volunteers. These trials are conducted across multiple countries.
BGB-11417 is also known as sonrotoclax. The drug is being developed by BeOne Medicines Ltd. and is currently in clinical trials for various blood cancers, including acute myeloid leukemia and mantle cell lymphoma.