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A Phase 2 Efficacy and Safety Trial of ADU-S100 and Pembrolizumab in Adults with Head and Neck Cancer
This study is an open-label, multicenter Phase 2 clinical trial to evaluate the efficacy and safety of intratumoral ADU-S100 (also referred to as MIW815) administered with pembrolizumab in the first-line setting. The population will consist of adults with PD-L1 positive recurrent or metastatic HNSCC.
Primary: Evaluate the clinical efficacy of ADUS100 administered in combination with pembrolizumab. Secondary: Characterize safety and tolerability, Further evaluate clinical activity, Characterize the pharmacokinetics (PK) of ADU-S100 administered by intratumoral injection following a single dose and multiple doses. Exploratory: Assess pharmacodynamic, immunomodulatory, and potential prognostic and/or predictive biomarkers and Pharmacogenetic analysis