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

• 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 quantitatively based on 24-hour urine collection can be enrolled;
• Allergic to macrolides;
• Uncontrolled hypertension (systolic > 150 mmHg and / or diastolic >100mmHg) or clinically significant (e.g. active) cardiovascular diseases - such as stroke (≤ 6 months before randomization), myocardial infarction (≤ 6 months before randomization), unstable angina pectoris, congestive heart failure of New York Heart Association (NYHA) functional class III or above, or serious arrhythmia that cannot be controlled with drugs or has potential impact on trial treatment.
• Known to have acute or chronic active HBV or HCV infection and need antiviral treatment with non nucleoside drugs;
• Women pregnant or lactation;
• Having participated in other clinical studies and received any other investigational drug for treatment within 30 days before enrollment;
• Having taken macrolide antibiotics (azithromycin, erythromycin, roxithromycin, clarithromycin, dirithromycin, spiramycin, acetylspiramycin, midecamycin, rokitamycin, meleumycin, josamycin, leucomycin, miocamycin) within 3 days before enrollment;
• Other cases considered inappropriate by the investigator to participate in the study.