A Window of Opportunity Study of KTN3379 in Surgically Resectable Head and Neck Cancer Patients

Inclusion Criteria

• •1. Histologically or cytologically confirmed primary, untreated SCCHN including variants. Patients must be candidates for surgical resection. Primary tumors of oral cavity, oropharynx, hypopharnyx or larynx are included.
• •2. Written informed consent and any locally required authorization (e.g., HIPAA in the USA) obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations.
• •3. Females of childbearing potential who are sexually active with a nonsterilized male partner must use 2 methods of effective contraception from screening, and must agree to continue using such precautions for 60 days after the final dose of KTN3379. Females of childbearing potential are defined as those who are not surgically sterile (i.e., bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or those who are postmenopausal (defined as 12 months with no menses without an alternative medical cause)
• •4. Nonsterilized males who are sexually active with a female partner of child-bearing potential must, with their partner, use 2 acceptable methods of effective contraception from Day 1 through 60 days after receipt of the final dose of KTN3379.
• •5. Eastern Cooperative Oncology Group (ECOG) status of 0 or 1
• •6. Adequate bone and marrow function as defined below:
• •* Hemoglobin ≥ 10 g/dL
• •* Absolute neutrophil count ≥ 1500/mm3
• •* Platelet count ≥ 100,000/mm3
• •* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 ×ULN
• •* Bilirubin ≤ 1.5 × ULN except for cases of documented or suspected Gilbert's disease, in which bilirubin must be ≤ 5 × ULN
• •* Serum creatinine ≤ 1.5 g/dL
• •* Normal PT or INR and aPTT