Pembrolizumab and ADG106 in Advanced Solid Cancers and Triple Negative Breast Cancer

2.1 Hypothesis * Combination of ADG106 and pembrolizumab is safe with a reasonable toxicity profile. * Combination of ADG106 and pembrolizumab is effective and can improve outcomes in patients with advanced TNBC. * Predictive biomarkers may help select patients most likely to benefit from combination therapy. 2.2 Primary Objectives Phase Ib * Evaluate the safety and tolerability of combination of ADG106 with pembrolizumab in patients with advanced solid tumors. * Determine recommended phase II dose (RP2D) of ADG106 in combination with pembrolizumab. Phase II • Evaluate the clinical efficacy of ADG106 plus pembrolizumab in terms of ORR in patient with advanced TNBC with CPS ≥1 2.3 Secondary Objectives Phase Ib • Evaluate preliminary anti-tumor effect of combination of ADG106 with pembrolizumab in terms of ORR, disease control rate (DCR), PFS and OS in patients with treatment refractory solid tumors Phase II * Evaluate clinical efficacy of ADG106 plus pembrolizumab in terms of DCR, PFS and OS in patients with advanced TNBC with CPS≥1 * Evaluate clinical efficacy of ADG106 plus pembrolizumab in terms of ORR, DCR, PFS and OS in patients with advanced TNBC with CPS≥10 2.4 Exploratory Objectives * Evaluate predictive biomarkers (e.g., tumor PD-L1 CPS score) for response to ADG106 plus pembrolizumab. * Evaluate changes in tumor microenvironment with combination of ADG106 plus pembrolizumab. * Evaluate changes in tumor genomic expression profile with combination of ADG106 plus pembrolizumab.