The study will determine the safety, tolerability, recommended Phase 2 dose (RP2D) and preliminary efficacy of BGB-11417 as monotherapy and in combination with azacitidine in participants with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS)or MDS/myeloproliferative neoplasm (MPN).
| Study Arm | Population | Intervention | Comparison | Outcome |
|---|---|---|---|---|
Part 1: Dose escalation |
AML |
Sonrotoclax + Azacitidine |
None |
Primary Endpoint: safety (DLTs, TEAEs) Key Secondary Endpoints: CR + CRh rate, PK/PD |
Part 2: Safety expansion |
AML |
Sonrotoclax + Azacitidine |
None |
Primary Endpoint: safety (DLTs, TEAEs) Key Secondary Endpoints: CR + CRh rate, PK/PD |
Part 3: Efficacy expansion |
AML |
Sonrotoclax + Azacitidine |
None |
Primary Endpoint: CR + CRh rate, PK/PD Key Secondary Endpoint: Safety |
