The purpose of this study is to evaluate the safety and tolerability of BGB-11417 monotherapy, define the maximum tolerated dose (MTD) or maximum administered dose and the recommended Phase 2 dose (RP2D) of BGB-11417 monotherapy for the selected B-cell malignancy dose finding cohorts, and evaluate the safety and tolerability of the ramp-up dosing schedule in the evaluated disease types.
This study will have 3 cohorts for determining a monotherapy MTD and ramp-up schedule: Cohort A, participants with relapsed/refractory B-cell non-Hodgkin lymphoma (R/R NHL); Cohort B, participants with R/R chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) with low tumor burden; Cohort C, participants with R/R CLL/SLL with high tumor burden.
| Study Arm | Population | Intervention | Comparison | Outcome |
|---|---|---|---|---|
Cohort A |
R/R NHL (FL, MZL, DLBCL, or TF-NHL) |
Sonrotoclax |
None |
Primary Endpoint: RP2D and/or MTD, safety, tolerability, incidence, and severity of TLS-relevant events |
Cohort B |
R/R CLL/SLL with low tumor burden |
Sonrotoclax |
None |
Primary Endpoint: RP2D and/or MTD, safety, tolerability, incidence, and severity of TLS-relevant events Key Secondary Endpoints: PK, ORR (INV) |
Cohort C |
R/R CLL/SLL with high tumor burden |
Sonrotoclax |
None |
Primary Endpoint: RP2D and/or MTD, safety, tolerability, incidence, and severity of TLS-relevant events Key Secondary Endpoints: PK, ORR (INV) |
