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.
This is a phase Ib followed by phase II clinical trial evaluating the safety and efficacy of combination of ADG106 with pembrolizumab in patients with metastatic cancers. The Phase Ib dose finding part will include all solid tumor subtypes with treatment refractory disease, while phase II will focus on only patients with TNBC.