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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03050047
Recruitment Status : Active, not recruiting
First Posted : February 10, 2017
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
Biocad

Brief Summary:
A Multicenter Open-Label Single-Arm Multi-Cohort Phase I Study of Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of BCD-100 (JSC BIOCAD, Russia) in Patients with Advanced Solid Tumors

Condition or disease Intervention/treatment Phase
Melanoma Lung Cancer Renal Cell Carcinoma Biological: BCD-100 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Open-Label Single-Arm Multi-Cohort Phase I Study of Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of BCD-100 (JSC BIOCAD, Russia) in Patients With Advanced Solid Tumors
Actual Study Start Date : August 30, 2016
Actual Primary Completion Date : July 1, 2017
Estimated Study Completion Date : November 2018


Arm Intervention/treatment
Experimental: BCD-100 0.3 mg/kg
Patients who receive BCD-100 in a dose of 0.3 mg/kg
Biological: BCD-100
Anti-PD1 monoclonal antibody

Experimental: BCD-100 1 mg/kg
Patients who receive BCD-100 in a dose of 1 mg/kg
Biological: BCD-100
Anti-PD1 monoclonal antibody

Experimental: BCD-100 3 mg/kg
Patients who receive BCD-100 in a dose of 3 mg/kg
Biological: BCD-100
Anti-PD1 monoclonal antibody

Experimental: BCD-100 10 mg/kg
Patients who receive BCD-100 in a dose of 10 mg/kg
Biological: BCD-100
Anti-PD1 monoclonal antibody




Primary Outcome Measures :
  1. ORR (CR + PR) [ Time Frame: 85 days ]

    Pilot efficacy assessment is not the primary objective of this study and will be conducted by surrogate endpoints describing the direct antitumor effect of the drug.

    • ORR (CR + PR) after 85 days of therapy with BCD-100.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03050047


Locations
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Russian Federation
"Russian Cancer Research Center named after N.N. Blokhin "of the Ministry of Health of the Russian Federation
Moscow, Russian Federation
LLC BioEk
Saint-Petersburg, Russian Federation
State budgetary health care institution "St. Petersburg Clinical Scientific and Practical Center of Specialized Medical Assistance (Oncological)"
Sankt Petersburg, Russian Federation
N.N.Petrov Oncology Research Center
St.Petersburg, Russian Federation, 197758
Sponsors and Collaborators
Biocad
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Responsible Party: Biocad
ClinicalTrials.gov Identifier: NCT03050047    
Other Study ID Numbers: BCD-100-1
First Posted: February 10, 2017    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma, Renal Cell
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases