Safety, Tolerability, Pharmacokinetics & Pharmacodynamics of an Anti-PD-1 mAb for Patients With Advanced Solid Tumors

Inclusion Criteria:

1. Willing to sign Informed Consent;
2. Re-entry into the study is allowed with a second informed consent;
3. Willing to provide blood sample for biomarker analysis(mandatory). The tissue sample is optional;
4. A diagnosis of an advanced malignant tumor confirmed by histology or cytology;
5. No standard of care for the patient;
6. At least 1 measurable lesion;
7. Aged 18-65 years;
8. Anticipated life expectancy of at least 3 months;
9. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
10. i) At least 4 weeks elapsed since receiving systemic chemotherapy, at least 6 weeks since receiving mitomycin or nitrosoureas, and at least 2 weeks since receiving a tyrosine kinase inhibitor;
11. At least 4 weeks elapsed since receiving definite radiotherapy, and at least 2 weeks since receiving palliative radiotherapy;
12. At least 2 weeks since the last dose of systemic steroid therapy (\>10 mg/day prednisone or equivalent);
13. At least 4 weeks since receiving anti-cancer biotherapy;
14. Recovered from previous treatment related adverse reaction;
15. willing to use an acceptable contraceptive method;
16. A negative pregnancy test for female subjects of childbearing potential;

Exclusion Criteria:

1. Active central nervous system (CNS) metastases and/or carcinomatous meningitis;
2. Known history of another primary solid tumor, unless the participant has undergone potentially curative therapy with no evidence of that disease for 2 years, or underwent successful definitive resection of basal or squamous cell carcinoma of the skin, or in situ cervical cancer;
3. Active, known or suspected autoimmune disease;
4. Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2,or anti-cytotoxic T-lymphocyte antigen 4 (CTLA-4) blocking antibodies;
5. Significant medical disease;
6. Active infection;
7. Active tuberculosis or history of tuberculosis with one year;
8. Infection of Human immunodeficiency virus (HIV);
9. A complication requiring immune-suppression;
10. Received a live vaccine within 4 weeks prior to first dose of study drug
11. pleural or abdominal effusion with symptoms;
12. Drug or alcohol abuse (for subjects in the pharmacokinetic cohorts) ;
13. evidence of interstitial lung disease;
14. Active hepatitis B or C, or with significant risk of hepatitis reactivation;
15. Known immediate or delayed hypersensitivity reaction or idiosyncrasy to monoclonal antibodies or drugs chemically related to the study drug. History of serious hypersensitivity reaction or serious hepatotoxicity related to any drug.