Last updated on September 2018

A Multicenter Open-Label Single-Arm Multi-Cohort Phase I Study of BCD-100 in Patients With Advanced Solid Tumors


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Bronchial Neoplasm | skin cancer | melanoma | Renal Cell Carcinoma | Lung Neoplasm
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

Inclusion Criteria:

  1. Patient provides a written informed consent and is able to follow the requirements of the Protocol;
  2. Age 18 years
  3. Histologically confirmed cancer (well-documented test results; preferably, block specimens available):
    • unresectable (stage III/IV) or metastatic (stage IV) melanoma (the drug will be used as the first of subsequent therapy lines);
    • Locally advanced or metastatic NSCLC (squamous cell carcinoma/adenocarcinoma), progressive after at least the first-line therapy (the drug will be used as a second or subsequent therapy lines);
    • Metastatic clear cell renal carcinoma, progressive after at least the first-line therapy (the drug will be used as a second or subsequent therapy lines);

In addition, by investigator's decision, patients with the following malignancies can also be enrolled in the study :

  • Pleural mesothelioma progressive after at least one therapy line (the drug will be used as a second or subsequent therapy lines);
  • Metastatic bladder cancer progressive after at least one therapy line (the drug will be used as a second or subsequent therapy lines);
  • Triple negative breast cancer (ER-, PR-, HER2-) progressive after at least the first-line therapy (the drug will be used as a second or subsequent therapy lines); 4. ECOG score of 0 to 2; 5. Measurable disease (at least one lesion) according to RECIST v. 1.1 ; 6. Resolved toxicity events from the previous therapy or adverse consequences of surgical interventions to grade 1 CTCAE v. 4.03, except for chronic/irreversible adverse events not affecting the safety of the study therapy (e.g. alopecia); 7. No severe pathology of organs or systems; 8. Life expectancy of at least 12 weeks from the screening; 9. Patients of childbearing potential enrolled in the study must agree to use reliable contraception methods throughout the study period, beginning 2 weeks before the inclusion in the study and up to 8 weeks after the last dose of BCD-100.

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, progressive or associated with clinical symptoms (e.g. cerebral edema or spinal cord compression). Exclusions: metastases that do not progress and do not require steroids and/or anticonvulsants within at least 4 weeks before randomization ;
  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. Prior anticancer treatment within 28 days before starting the study drug (surgery, radiation therapy , or chemotherapy);
  10. Known history of more than 6 lines of systemic anticancer chemotherapy (including neoadjuvant and adjuvant CTs);
  11. Prior treatment with anti-PD1/PDL1 agents or CTLA4 inhibitors;
  12. Concurrent malignancy except for radically resected cervical carcinoma in situ or radically resected basal cell/squamous cell carcinoma;
  13. Conditions limiting patient's ability to follow the Protocol requirements (dementia, neurological or psychiatric disorders, drug or alcohol abuse, etc.);
  14. 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.
  15. Acute infections or active chronic infections;
  16. Documented HIV infection;
  17. Positive screening results for Hbs-antigen, hepatitis B core antibodies (anti-HBc Ab) and/or hepatitis C antibodies ;
  18. Positive results of microprecipitation reaction together with positive TPHA assay results at the screening;
  19. Body weight > 95 kg.
  20. Intravenous administration of the drug is impossible;
  21. Intravenous administration of contrast agents is impossible;
  22. Hypersensitivity to any component of BCD-100.
  23. Known history of hypersensitivity to monoclonal antibodies;
  24. Pregnancy or breastfeeding;

Recruitment Status: Closed


Brief Description Eligibility Contact Research Team


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