Study of CX1106 in Patients With Advanced Head and Neck Squamous Cell Carcinoma

Inclusion Criteria: * Histologically or cytologically confirmed HNSCC (excluding nasopharyngeal carcinoma); * At least one measurable lesion (spiral CT scan long diameter ≥ 10 mm or enlarged lymph node short diameter ≥ 15 mm by RECIST 1.1); * Documented disease progression after prior platinum-based systematic therapy; or prior platinum-based adjuvant/neoadjuvant therapy with documented disease progression within 24 weeks after treatment completion; * Expected overall survival≥ 3 months; * ECOG PS≤1; Exclusion Criteria: •Hematologic, renal, and hepatic function as defined below: Absolute neutrophil count (ANC) \<1.5×109 /L or platelet \<100×109 /L or hemoglobin \<9 g/dL; Total bilirubin \>1.5×the upper limit of normal range(ULN); Aspartate aminotransferase (AST) and/or Alanine transaminase (ALT) and/or Alkaline phosphatase (ALP) \>1.5×ULN without liver metastases ; AST and/or ALT and/or ALP levels \>5×ULN with liver metastases. Primary hepatocellular carcinoma: Child-Pugh liver is grade C; Serum creatinine\>1.5 ×ULN or creatinine clearance (CL) \< 60 mL/min; International normalized ratio (INR) or activated partial thromboplastin time (aPPT) \>1.5×ULN; * Patients who has accepted systemic anti-tumor therapy, including chemotherapy, radiotherapy, hormonal therapy , biologics therapy or immunotherapy within 4 weeks; * Any unresolved Grade ≥2 toxicity by NCI CTCAE 5.0 from previous anticancer therapy excluding skin pigmentation and alopecia; * Untreated brain metastases or symptoms of brain metastases cannot be controlled more than 4 weeks; * Other kinds of malignancies \[excluding stage IB or lower grade cervical cancer，noninvasive basal cell or squamous cell cancer, breast cancer with complete remission (CR) \> 10 years ,melanoma with CR \>10 years or other malignant tumors with CR \> 5 years\]; * Any of the following gastrointestinal disease: Need intravenous nutrition; Received treatment for active peptic ulcer disease in the past 6 months; Active gastrointestinal bleeding unrelated to cancer in the past 3 months; Persistent 3 or 4 grade chronic diarrhea although with treatment; * Presence of hemorrhage (hemoptysis) , thrombosis，or currently receiving treatment with warfarin, aspirin, low molecular weight heparin (LMWH), or any other anti-platelet drugs(low dose of abovementioned drugs for prophylaxis are allowed); * Active infections, mental and neurological diseases; * Prior to enrollment within 12 months , patients who had cardiovascular and cerebrovascular disease, deep vein thrombosis or pulmonary embolism within 6 months; or uncontrolled hypertension,systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥ 90 mmHg; * Prior to enrollment within 30 days , patients who had Major surgical procedure, open biopsy, or significant traumatic injury; * Hepatitis B surface antigen (HBsAg) positive and HBV-DNA≥ 2000 IU / mL;hepatitis C virus (HCV) antibody positive; and cirrhosis; * Known history of human immunodeficiency virus (HIV) infection; * Pregnant or lactating women or those who do not take contraceptives, including men; * Prior to enrollment within 30 days , patients who have participated in other clinical trials of anti-tumor medicine; * Diseases which would severely endanger the security of patients or influence the completion of this research.