Clinical trial objectives
±, tumor
SECONDARY, INFILTRATION, TUMOR
The primary objectives were to assess DLT, to establish MTD or MAD of tebotelimab ± margetuximab and to characterize safety and tolerability of tebotelimab ± margetuximab. The secondary objectives included pharmacokinetics, immunogenicity and preliminary anti-tumor activity of tebotelimab ± margetuximab. Exploratory objectives included: to investigate immune-regulatory activity of tebotelimab ± margetuximab in vivo, including various measures of T cell activation in peripheral blood and/or tumor biopsy specimens; to determine relationships among PD‑1, PD‑L1, LAG‑3, HER2 expression and gene expression profiling in tumor cells and immune cell infiltration within biopsy specimens (including CD4