Study consists of two main parts to explore BGB-16673 recommended dosing, a Phase 1 monotherapy dose finding comprised of monotherapy dose escalation and monotherapy safety expansion of selected doses, and a Phase 2 (expansion cohorts)
| Study Arm | Population | Intervention | Comparison | Outcome |
|---|---|---|---|---|
Part 1a: dose escalation |
R/R MZL, R/R FL, R/R MCL, R/R CLL/SLL, R/R WM, R/R DLBCL, R/R RT |
BGB-16673 |
None |
Primary Endpoints: Safety and tolerability, MTD, RP2D Key Secondary Endpoints: PK/PD, preliminary antitumor activity |
Part 1b: safety expansion |
R/R MZL, R/R MCL, R/R CLL/SLL, R/R WM |
BGB-16673 |
None |
Primary Endpoints: Safety and tolerability, MTD, RP2D Key Secondary Endpoints: PK/PD, preliminary antitumor activity |
Part 1c: additional safety expansion |
R/R MZL, R/R WM, R/R RT, R/R DLBCL, R/R FL |
BGB-16673 |
None |
Primary Endpoints: Safety and tolerability, MTD, RP2D Key Secondary Endpoints: PK/PD, preliminary antitumor activity |
1d: additional safety expansion |
R/R CLL/SLL |
BGB-16673 |
None |
Primary Endpoints: Safety and tolerability, MTD, RP2D Key Secondary Endpoints: PK/PD, preliminary antitumor activity |
Part 1e: additional safety expansion (Japan only) |
R/R MZL, R/R FL, R/R MCL, R/R CLL/SLL, R/R WM |
BGB-16673 |
None |
Primary Endpoint: Safety and tolerability, MTD, RP2D Key Secondary Endpoints: PK/PD, preliminary antitumor activity |
Part 1e: monotherapy safety expansion |
BTKi-Naïve: R/R MZL, R/R MCL, R/R CLL/SLL, R/R WM, R/R RT |
BGB-16673 |
None |
Primary Endpoint: Safety and tolerability, MTD, RP2D Key Secondary Endpoints: PK/PD, preliminary antitumor activity |
Part 2: dose expansion |
Cohort 1: Post-BTKi R/R CLL/SLL |
BGB-16673 |
None |
Primary Endpoint: Safety and tolerability, MTD, RP2D Key Secondary Endpoints: PK/PD, preliminary antitumor activity |
