A Phase I Comparative Study of Pharmacokinetics, Safety, and Efficacy of RPH-002 and Erbitux® in Unresectable Metastatic or Recurrent Head and Neck Squamous Cell Carcinoma

Inclusion criteria

• ✓. A voluntarily signed and dated Informed Consent form (ICF) of the patient
• ✓. Histologically confirmed squamous cell carcinoma of the head and neck
• ✓. Body mass index (BMI) between 18 and 30 kg/m\^2, inclusive
• ✓. Documented unresectable locoregional recurrence or distant metastases, or progression after prior chemoradiotherapy or combination therapy completed \>3 months before screening, not amenable to local treatment (except cases with high risk of tumor lysis or bleeding), or newly diagnosed metastatic disease not previously treated with systemic therapy. Study treatment is first-line therapy
• ✓. At least one measurable lesion per RECIST 1.1
• ✓. Karnofsky performance status ≥70%
• ✓. Screening laboratory values within the following limits (per local lab normal ranges):
• ✓. Men and women of childbearing potential, and women within 2 years of menopause, must agree to use reliable contraception from informed consent through at least 6 months after study treatment; women of childbearing potential must have a negative urine pregnancy test. Women with no reproductive potential (≥2 years post-menopause or surgically sterile) are exempt

Exclusion criteria