Head and Neck Squamous Cell Carcinoma Clinical Trial
Official title:
Phase I/II Open Label Study Evaluating the Safety and Efficacy of Combining STAT3 Inhibition (TTI-101) With Anti-PD-1 Therapy (Pembrolizumab) in Patients With Recurrent or Metastatic (RM) Head and Neck Squamous Cell Carcinoma (HNSCC)
To review safety and efficacy of TTI-101 plus Pembrolizumab in patients the Recurrent and Metastatic head and Neck Squamous Cell Carcinoma.
Primary Objectives: - Objective (Phase I): Determine the phase II dose of TTI-101 when used in combination with pembrolizumab in solid tumor patients. - Objective (Phase II): Determine the overall response rate (ORR) and progression free survival (PFS) of the combination evaluated according to RECIST criteria. Secondary Objectives: - Objective: Determine the overall survival in HNSCC patients treated with the combination. - Objective: Determine the rate of immune-related severe adverse events (irSAEs) of the combination. - Objective: Evaluate the safety of the combination in solid tumor patients. Secondary Endpoint: Overall SAEs, SAEs resulting in death, discontinuation, dose reduction or dose interruption, frequency, and time to onset and severity of AEs. Exploratory Objectives: --Objective: Determine the relationship between pharmacokinetics, pharmacodynamics, baseline and post-treatment immune and tumor biomarkers and clinical responses in patients treated with the combination. ;
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