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A Phase 1, First-in-Human, Open-Label, Dose Escalation and Expansion Study of CUE-101 Monotherapy in Second Line and CUE-101 Combination Therapy with Pembrolizumab in First Line Patients with HPV16+ Recurrent / Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)
This is a multi center, open-label, phase 1 dose escalation and expansion study evaluating the safety, anti-tumor effect, and immunogenicity of CUE-101 in patients with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC).
Part A: Dose escalation and expansion of CUE-101 as monotherapy Part B: Dose confirmation Co-primary objectives: > To assess the safety and tolerability of CUE-101 in subjects with recurrent/metastatic HPV16-driven malignancies (HLA-A*0201, HPV16+ disease: HPV 16 genotyping, plus tumor p16+) and to determine the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) based on markers of biological activity (biologically effective dose) (Part A) > To evaluate the pharmacokinetics (PK) of CUE-101 when administered in subjects with recurrent/metastatic HPV16-driven malignancies (Parts A and B) Secondary objectives: > To confirm safety and evaluate antitumor activity at the RP2D (Part B) > To assess the preliminary antitumor activity of CUE-101 based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (Parts A and B) > To assess the potential for immune response upon treatment with CUE-101 (Parts A and B) > To assess the potential immunogenicity of CUE-101 (Parts A and B)