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.