The purpose of this study is to determine the safety, tolerability; and to define the maximum tolerated dose (MTD) and Recommended Phase 2 Dose (RP2D); and to evaluate the safety and tolerability of the ramp-up dosing schedule and at the RP2D of BGB-11417 monotherapy, and when given in combination with zanubrutinib and obinutuzumab.
| Study Arm | Population | Intervention | Comparison | Outcome |
|---|---|---|---|---|
Part 1: Sonrotoclax Monotherapy Dose Finding |
R/R NHL (FL, DLBCL, MZL, transformed NHL), R/R CLL/SLL, R/R MCL, R/R WM |
Sonrotoclax |
None |
Primary Endpoints: Safety (TEAEs, SAEs, AEs leading to discontinuation, TLS), MTD, RP2D Secondary Endpoints: PK/PD, ORR (INV) |
Part 2: Sonrotoclax Monotherapy Expansion Cohorts |
R/R indolent NHL (FL, MZL), R/R aggressive NHL (DLBCL, transformed NHL), R/R CLL/SLL, R/R MCL, R/R WM |
Sonrotoclax |
None |
Primary Endpoints: Safety (TEAEs, SAEs, AEs leading to discontinuation, TLS), MTD, RP2D Secondary Endpoints: PK/PD, ORR (INV) |
Part 3: Sonrotoclax + Zanubrutinib Combination Therapy Dose Finding |
R/R CLL/SLL, R/R MCL, TN CLL/SLL |
Sonrotoclax + Zanubrutinib |
None |
Primary Endpoints: Safety (TEAEs, SAEs, AEs leading to discontinuation, TLS), MTD, RP2D Secondary Endpoints: PK/PD, ORR (INV) |
Part 4: Sonrotoclax + Zanubrutinib Combination Therapy Dose Expansion |
R/R CLL/SLL, TN CLL/SLL, R/R MCL |
Sonrotoclax + Zanubrutinib |
None |
Primary Endpoints: Safety (TEAEs, SAEs, AEs leading to discontinuation, TLS), MTD, RP2D Secondary Endpoints: PK/PD, ORR (INV) |
