Phase I Study of BCD-145 (Anti-CTLA-4) in Patients With Unresectable/Metastatic Melanoma

Exclusion Criteria

• •1. Severe concomitant illnesses or life-threatening consequences (including pleural/pericardial/peritoneal effusion that requires medical intervention , pulmonary lymphangitis, or involvement of \>50% renal parenchyma);
• •2. Brain metastases ;
• •3. Severe cardiovascular disorders within 6 months before screening;
• •4. Autoimmune diseases;
• •5. Conditions requiring steroids or any other immunosuppressants;
• •6. Blood disorders: ANC ≤1,500/mm3; platelets ≤100,000/mm3; or Hb ≤90 g/L;
• •7. Renal function impairment: creatinine ≥1.5 × ULN;
• •8. Hepatic function impairment: bilirubin ≥1.5 × ULN; AST and ALT ≥2.5 × ULN (5 × ULN for patients with liver metastases), AlkPh ≥ 5 × ULN;
• •9. Endocrine disorders: abnormal thyroid hormones
• •10. Prior anticancer treatment within 28 days before starting the study drug (surgery, radiation therapy , or chemotherapy);
• •11. Known history of more than 6 lines of systemic anticancer chemotherapy (including neoadjuvant and adjuvant CTs);
• •12. Prior treatment with anti-PD1/PDL1 agents or CTLA4 inhibitors;
• •13. Concurrent malignancy except for radically resected cervical carcinoma in situ or radically resected basal cell/squamous cell carcinoma;
• •14. Conditions limiting patient's ability to follow the Protocol requirements (dementia, neurological or psychiatric disorders, drug or alcohol abuse, etc.);
• •15. Simultaneous participation in any other clinical trial; participation in other clinical trials within 30 days before inclusion in the present study; previous participation in the present study.
• •16. Acute infections or active chronic infections;
• •17. Documented hepatitis B, active hepatitis C, HIV or syphilis infection;
• •18. Intravenous administration of the drug is impossible;
• •19. Intravenous administration of contrast agents is impossible;
• •20. Hypersensitivity to any component of BCD-145.
• •21. Known history of hypersensitivity to monoclonal antibodies;
• •22. Pregnancy or breastfeeding;