A Phase 2 Open Label Study of BA3021 in Patients with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

Eligibility Criteria

• * The eligible primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx. Patients may not have a primary tumor site of nasopharynx (any histology).
• * Neoadjuvant/induction setting (Cohort N1): Patient with newly diagnosed Stage III SCCHN who are eligible for induction therapy with resectable tumors. No prior treatments, including surgery, radiation, or systemic treatment, for SCCHN are allowed.
• * Recurrent or metastatic setting: Histologically or cytologically confirmed recurrent or metastatic SCCHN Stage III/IV and not amenable to local therapy with curative intent (surgery or radiation therapy with or without chemotherapy).
• * First-line - Combination Cohorts (C1 and C2): Patients must have NO prior systemic therapy administered in the locally recurrent or metastatic setting. Previous treatments with PD-1/L1 inhibitor or anti-CTLA-4 treatment are not allowed.
• * Second-line (Combination Cohort C3) and Second-line+ (Monotherapy Cohorts M1 and M2): Patients must have documented treatment failure of no more than one approved PD-1/L1 inhibitor either administered alone or in combination.
• * Age ≥ 18 years
• * Adequate renal function
• * Adequate liver function
• * Adequate hematological function
• * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• * Patients must not have a history of ≥ Grade 3 allergic reactions to mAb therapy as well as known or suspected allergy or intolerance to any agent given during this study.
• * Patients must not have known human immunodeficiency virus (HIV) infection, active hepatitis B and/or hepatitis C.
• * Patients must not be women who are pregnant or are breast feeding.