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

August 29, 2018 updated by: Biocad

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Moscow, Russian Federation
        • "Russian Cancer Research Center named after N.N. Blokhin "of the Ministry of Health of the Russian Federation
      • Saint-Petersburg, Russian Federation
        • LLC BioEk
      • Sankt Petersburg, Russian Federation
        • State budgetary health care institution "St. Petersburg Clinical Scientific and Practical Center of Specialized Medical Assistance (Oncological)"
      • St.Petersburg, Russian Federation, 197758
        • N.N.Petrov Oncology Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SEQUENTIAL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
85 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biocad

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 30, 2016

Primary Completion (ACTUAL)

July 1, 2017

Study Completion (ANTICIPATED)

November 1, 2018

Study Registration Dates

First Submitted

February 8, 2017

First Submitted That Met QC Criteria

February 8, 2017

First Posted (ACTUAL)

February 10, 2017

Study Record Updates

Last Update Posted (ACTUAL)

August 31, 2018

Last Update Submitted That Met QC Criteria

August 29, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BCD-100-1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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