Endpoints and assessments
tumour
DISEASE, SOLID TUMOUR, TUMOUR, SECONDARY
The primary objectives for Phase 1a (dose escalation for BGB-A333 monotherapy) and Phase 1b (dose confirmation for BGB-A333 and tislelizumab combination) were to determine the RP2D for BGB-A333 alone and in combination with tislelizumab, and to assess the safety and tolerability of BGB-A333 alone and in combination with tislelizumab in patients with advanced solid tumours. The primary objective for Phase 2 (combination dose expansion) was to evaluate the investigator-assessed ORR per RECIST v1.1 [The secondary objectives for Phase 1a and Phase 1b were to assess the preliminary anti-tumour activity, PK and host immunogenicity (assessed via the incidence of antidrug antibodies [ADAs]) of BGB-A333 alone and in combination with tislelizumab. The secondary objectives for Phase 2 (combination dose expansion) were to assess other tumour assessment outcomes, specific duration of response (DoR), PFS and disease control rate per RECIST v1.1 [Exploratory endpoints for Phase 1b and 2 (combination dose expansion) included potential predictive biomarkers in archival and/or fresh tumour tissue and association with response to BGB-A333 alone and in combination with tislelizumab.