Clinical Study of Safety and Tolerability of CBLB502 as a Neo-adjuvant Treatment in Patients With Colorectal Cancer

February 8, 2017 updated by: BioLab 612 LLC

Randomized Single-blind Placebo-controlled Clinical Study of Safety and Tolerability of CBLB502 as a Neo-adjuvant Treatment in Patients With Colorectal Cancer, With Different Doses and Regimens

Randomized Single-blind Placebo-controlled Clinical Study of Safety and Tolerability of CBLB502 as a Neo-adjuvant Treatment in Patients With Colorectal Cancer, With Different Doses and Regimens

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

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
        • Federal State Budgetary Institution "State Scientific Center of Coloproctology named after A.N. Ryzhikh" Ministry of Health of the Russian Federation

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Written Patient Informed Consent for participation in the study
  2. Men and women in the age above 18 years
  3. Patients with confirmed diagnosis of colorectal cancer, indication to scheduled surgery for primary tumor removal
  4. Should not have any previous anticancer therapy
  5. Patient's life expectancy more than 3 months
  6. ECOG performance status 0-1

  7. Adequate hepatic and renal function:

    • Total bilirubin ≤1.5 upper limit of normal (ULN)),
    • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x ULN, regardless of the presence of liver metastases,
    • Creatinine ≤2 x ULN

  8. Adequate cardiac function including:

    • LVEF ≥45 by echocardiogram (ECHO) or multi gated acquisition scan,
    • 12-lead electrocardiogram (ECG) with normal tracing or non-clinically significant changes that do not require medical intervention,
    • QTcB interval QT (QTc by Bazett's formula) < 470 msec and no history of Torsades des Pointes or other symptomatic QTcB abnormality,
    • Absence of orthostatic hypotonia
  9. Negative testing for serological markers of HIV-infection, viral hepatitis В and С, syphilis
  10. Content to use barrier contraception methods by male/female patient and his/her partner in the study period

Exclusion Criteria:

  1. Inability to obtain written Informеd consent for participation in the study

  2. History of cardiovascular abnormalities including any conditions stated below:

    • Myocardial infarction/stroke for the last 6 months,
    • Stable abnormalities in regional contractility,
    • Cardiac failure (NYHA functional class III-IV),
    • Confirmed cardiomyopathy,

    • Clinically significant arrhythmias including any conditions stated below:

      • QT prolongation syndrome,
      • History of II or III-degree AV-block,
      • Bradycardia (HR < 50 beats per min.) or tachycardia (HR >100 beats per min.)

    • Blood pressure abnormalities:

      • 2 degree uncontrolled arterial hypertension (systolic blood pressure > 160 mm Hg or diastolic blood pressure > 105 mm Hg),
      • Hypotension (systolic blood pressure < 90 mm Hg)
  3. History of severe allergic, systemic and other oncologic diseases
  4. Decompensated diabetes mellitus with glycolated hemoglobin level (HbA1c) > 7%
  5. Administration of drug products with evident effect on immune system for previous 3 months prior screening (including corticosteroids. Remark: Topical agents (e.g. for rash treatment), inhalation aerosols (e.g. for treatment of broncho-obstructive diseases), eye drops and agents for local administration (e.g. to joint cavity) is allowed
  6. Participation in other clinical studies or administration of study products for 30 days prior screening, or persisting adverse reactions of the study product
  7. Patients that have not taken CBLB502
  8. Patients with hypersensitivity/allergy to CBLB502 or excipients of the drug product; NSAID (including ibuprofen)
  9. Pregnant or lactating women
  10. History of salmonellosis
  11. Body mass > 88 kg; no obesity which means BMI in the range 18.5-25 kg/m2 for women and 22-27 kg/m2 for men
  12. Men and women of childbearing age which do agree to use double contraception method, oral contraception or abstain from sex contacts throughout the study
  13. Alcohol abuse, drug abuse and any other medical, psychological and social reasons which may, in accordance with the investigator, affect patient's participation in the study, may prevent adequate assessment of the study results
  14. Any conditions which are unstable or may endanger patient's safety and/or affect his/her adherence to the investigator instruction
  15. Any patient is not able or willing to cooperate with the investigator

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 1 injection of CBLB502 0.35 μg/kg
One subcutaneous injection of CBLB502 0.35 μg/kg (not more 30 μg/injection) or Placebo at Day 1 before tumor removal
Drug: Placebo
Other Names:
  • PBS
  • Phosphate buffer saline
Drug: CBLB502
Other Names:
  • Entolimod
Experimental: 1 injection of CBLB502 0.45 μg/kg
One subcutaneous injection of CBLB502 0.45 μg/kg (not more 40 μg /injection) or Placebo at Day 1 before tumor removal
Drug: Placebo
Other Names:
  • PBS
  • Phosphate buffer saline
Drug: CBLB502
Other Names:
  • Entolimod
Experimental: 2 injections of CBLB502 0.35 μg/kg
Two subcutaneous injections of CBLB502 0.35 μg/kg (not more 30 μg/injection) or Placebo at Day 1 and Day 4 before tumor removal
Drug: Placebo
Other Names:
  • PBS
  • Phosphate buffer saline
Drug: CBLB502
Other Names:
  • Entolimod
Experimental: 2 injections of CBLB502 0.45 μg/kg
Two subcutaneous injections of CBLB502 at 0.45 μg/kg (not more 40 μg /injection) or Placebo at Day 1 and Day 4 before tumor removal
Drug: Placebo
Other Names:
  • PBS
  • Phosphate buffer saline
Drug: CBLB502
Other Names:
  • Entolimod

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Safety and tolerability evaluation as measured by adverse events and assessed as changes in vital signs and clinical laboratory measurements, physical examination findings and ECG readings
Time Frame: Baseline to up to 14 days after the drug administration
Baseline to up to 14 days after the drug administration

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Assessment of immune cells change in tumor by H&E and ICH staining
Time Frame: On Day 7 (Surgery day) after the drug administration
On Day 7 (Surgery day) after the drug administration
Determination of levels of cytokine IL-6 in blood by multiplex assays
Time Frame: Baseline to up to 7 days after the drug administration
Baseline to up to 7 days after the drug administration
Determination of levels of cytokine IL-8 in blood by multiplex assays
Time Frame: Baseline to up to 7 days after the drug administration
Baseline to up to 7 days after the drug administration
Determination of levels of cytokine IL-10 in blood by multiplex assays
Time Frame: Baseline to up to 7 days after the drug administration
Baseline to up to 7 days after the drug administration
Determination of levels of cytokine G-CSF in blood by multiplex assays
Time Frame: Baseline to up to 7 days after the drug administration
Baseline to up to 7 days after the drug administration
Determination of levels of cytokine TNFа in blood by multiplex assays
Time Frame: Baseline to up to 7 days after the drug administration
Baseline to up to 7 days after the drug administration
Specific T-cell responses measured by ELIspot
Time Frame: Baseline to up to 14 days after the drug administration
Baseline to up to 14 days after the drug administration
Antibody titer to CBLB502 as measured by ELISA
Time Frame: Baseline and on day 14 after the drug administration
Baseline and on day 14 after the drug administration
Blood leukocytes by FACS
Time Frame: Baseline to up to 7 days after the drug administration
Baseline to up to 7 days after the drug administration

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
BioLab 612 LLC

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Cleveland BioLabs, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sergei I. Achkasov, MD PhD, Federal State Budgetary Institution "State Scientific Center of Coloproctology named after A.N. Ryzhikh" Ministry of Health of the Russian Federation
  • Principal Investigator: Nikolay V. Kislov, MD PhD, Federal State Institution of Health of the Yaroslav Region "Regional Clinical Oncology Hospital"
  • Principal Investigator: Sergei V. Odintcov, MD PhD, Federal State Budgetary Institution "Central Clinical Hospital with polyclinic" Department of Presidential Affairs of the Russian Federation

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2015

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2017

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 17, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 22, 2016

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 9, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 8, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BL612-CBLB502

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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