Patritumab With Cetuximab and a Platinum Containing Therapy for Patients With Head and Neck Cancer

The trial will be performed in two "phases" (Periods):

Period 1: Initial phase in which the recommended phase 2 dose (RP2D) is determined

Period 2: Extension phase in which participants who are deriving benefit (stable disease or better) will have the opportunity to continue treatment at the discretion of the Investigator

Inclusion criteria

• Histologically or cytologically confirmed recurrent disease or metastatic SCCHN originating from the oral cavity, oropharynx, hypopharynx, and larynx
• Has documented disease recurrence following prior treatment
• Has Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
• Has adequate hematological function, per protocol
• Has adequate renal function, per protocol
• Has adequate hepatic function, per protocol
• Has prothrombin time (PT) or partial thromboplastin time (PTT) within 1.5 x upper limit of normal (ULN)
• Has a negative serum pregnancy test performed within 14 days prior to enrollment (where required by local regulations, test may be required within 72 hours prior to enrollment), if a woman of child-bearing potential
• Agrees to use double-barrier contraceptive measures, oral contraception, or avoidance of intercourse during the study and for 90 days after last study dose received, if of child-bearing potential
• Is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures

Exclusion criteria

• Has left ventricular ejection fraction (LVEF) < 50%
• Has received prior epidermal growth factor receptor (EGFR) targeted regimen
• Has received prior anti-HER2, anti-HER3, or anti-HER4 therapy
• Has received prior treatment for recurrent/metastatic disease
• Has history of other malignancies, except adequately treated non-melanoma skin cancer, curatively treated in-situ disease, or other solid tumors curatively treated with no evidence of disease for ≥ 5 years
• Has known history of and active brain metastases
• Has uncontrolled hypertension (systolic > 160 mm Hg or diastolic > 100 mm Hg)
• Has clinically significant electrocardiogram (ECG) changes
• Has had myocardial infarction within 1 year before enrollment, symptomatic congestive heart failure (New York Heart Association >Class II), unstable angina, or unstable cardiac arrhythmia requiring medication
• Had platinum-containing drug therapy/chemotherapy with radiotherapy < 6 months before study drug treatment
• Had therapeutic or palliative radiation therapy or major surgery within 4 weeks before study drug treatment.
• Participated in clinical drug trials within 4 weeks before study drug treatment or is currently participating in other investigational procedures
• Has uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or antifungals, known human immunodeficiency virus (HIV) infection, active hepatitis B or C infection, or is undergoing medical treatment for infection
• Has uncontrolled type 1 or 2 diabetes mellitus
• Has known hypersensitivity or allergic reaction against any of the components of the trial treatment
• Is pregnant, breastfeeding, or unwilling/unable to use acceptable contraception
• Has psychological, social, familial, or geographical factors that would interfere with study participation or follow up