Copanlisib in Association With Cetuximab in Patients With Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinomas Harboring a PI3KCA Mutation/Amplification and/or a PTEN Loss

Exclusion criteria

• ✕. Patients previously treated with PI3K and/or mTOR inhibitors
• ✕. Patients with anticancer therapy (radiotherapy, immunotherapy, chemotherapy, etc.) within 28 days or investigational treatment within 28 days prior to the initiation of study drug treatment, unless evidence of progression since last treatment
• ✕. Patients currently using other approved or investigational anti-neoplasic agent
• ✕. Patients with uncontrolled arterial hypertension despite optimal medical management, Congestive heart failure \> New York Heart Association (NYHA) class 2, Unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months). Myocardial infarction less than 6 months before start of test drug No active cardiac disease including any of the following: left ventricular ejection fraction (LVEF) \< 50% as determined by Multiple Gated Acquisition (MUGA) scan or echocardiogram (ECHO) and QTc \> 470 ms on screening ECG
• ✕. Patients with uncontrolled diabetes mellitus (patients with controlled Type I or II diabetes mellitus will be eligible but only into the phase II of the study and only if fasting HbA1c ≤ 8.5% at screening)
• ✕. Patients with a history of Human Immunodeficiency Virus (HIV) Hepatitis B (HBV) or hepatitis C (HCV) infection. All patients must be screened for HIV, HBV and HCV up to 28 days prior to first dosing using the routine virus laboratorial panel. Patients who are positive for HBs Ag or HBc Ab will be eligible if they are negative for HBV-DNA. Patients who are positive for anti-HCV antibody will be eligible if they are negative for HCV-RNA
• ✕. Patients with active uncontrolled or symptomatic central nervous system (CNS) metastases. Patients are eligible if their disease is controlled at least 30 days on corticosteroids prior to starting study drug
• ✕. Patients with major surgery within 28 days, or open biopsy within 7 days, prior to starting study drug. Patients must have recovered from major side effects of the surgery