Carrimycin in Patients With Locally Advanced, Recurrent, or Metastatic HNSCC (Non NPC): A Phase I Trial

Inclusion Criteria: * Locally advanced, recurrent, or metastatic head and neck squamous cell carcinoma (non NPC) confirmed by histopathological or cytological diagnosis * Expected life expectancy is no less than 6 months; * ECOG PS is 0, 1 or 2; * Subjects should be enrolled at least 4 weeks after the lastest treatment of surgery, radiotherapy, chemotherapy, or biotherapy, etc. * The laboratory inspection indexes should meet the following requirements: Leukocyte\>3×109/L, Neutrophils\>1.5×109/L, Platelet count\>75×109/L，Hemoglobin\>80g/L, Serum total bilirubin\<1.5ULN, ALT or AST\<2.5ULN, Creatinine\<2.0ULN, BUN\<2.0ULN, Maximum extension of APTT normal is within 10s, Maximum extension of PT normal is within 3s. * Women of reproductive age (18-45 years) must have a negative urine pregnancy test and agree to receive effective contraception. Male subjects must voluntarily receive appropriate contraception. Exclusion Criteria: * There is still any undiminished CTCAE grade 2 or higher toxicity from previous anti-cancer treatments; * There are significant cardiovascular abnormalities (e.g. myocardial infarction, upper-cavity venous syndrome, heart disease of grade 2 or higher diagnosed according to the New York Heart Association (NYHA) classification criteria 3 months prior to enrollment); * There is active severe clinical infection (\>NCI-CTCAE V5.0 Level 2) * Urine routine shows albuminuria ≥ ++, but if albuminuria at baseline ≥ ++, patients with albuminuria /24h\<1g measured…