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Colorectal CancerPhase 2NCT02715882

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

A Phase 2 study testing CBLB502 in people with Colorectal Cancer, run by BioLab 612 LLC at 1 site in Russia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer
What is being tested?
CBLB502
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteRussia
Study dates
Nov 2015to 31 Dec 2017
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Written Patient Informed Consent for participation in the study
  • Men and women in the age above 18 years
  • Patients with confirmed diagnosis of colorectal cancer, indication to scheduled surgery for primary tumor removal
  • Should not have any previous anticancer therapy
  • Patient's life expectancy more than 3 months
  • ECOG performance status 0-1
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  • 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
  • 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
  • Negative testing for serological markers of HIV-infection, viral hepatitis В and С, syphilis
  • Content to use barrier contraception methods by male/female patient and his/her partner in the study period

Who cannot join

  • Inability to obtain written Informеd consent for participation in the study
  • 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,
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  • 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)
  • History of severe allergic, systemic and other oncologic diseases
  • Decompensated diabetes mellitus with glycolated hemoglobin level (HbA1c) > 7%
  • 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
  • Participation in other clinical studies or administration of study products for 30 days prior screening, or persisting adverse reactions of the study product
  • Patients that have not taken CBLB502
  • Patients with hypersensitivity/allergy to CBLB502 or excipients of the drug product; NSAID (including ibuprofen)
  • Pregnant or lactating women
  • History of salmonellosis
  • 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
  • Men and women of childbearing age which do agree to use double contraception method, oral contraception or abstain from sex contacts throughout the study
  • 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
  • Any conditions which are unstable or may endanger patient's safety and/or affect his/her adherence to the investigator instruction
  • Any patient is not able or willing to cooperate with the investigator

Trial locations and contacts

1 site in 1 country.

Russia1 site

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

    Moscow

Other trials in Russia

About this study

Official title: 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

Being tested
CBLB502, Placebo
Keywords
Colorectal cancer, TLR5, Immunotherapy
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CBLB502Drug

    Also called Entolimod

  • PlaceboDrug

    Also called PBS, Phosphate buffer saline

Study groups in NCT02715882
Study groupRoleWhat they receive
1 injection of CBLB502 0.35 μg/kgExperimentalOne subcutaneous injection of CBLB502 0.35 μg/kg (not more 30 μg/injection) or Placebo at Day 1 before tumor removal
Receives: Drug: CBLB502; Drug: Placebo
1 injection of CBLB502 0.45 μg/kgExperimentalOne subcutaneous injection of CBLB502 0.45 μg/kg (not more 40 μg /injection) or Placebo at Day 1 before tumor removal
Receives: Drug: CBLB502; Drug: Placebo
2 injections of CBLB502 0.35 μg/kgExperimentalTwo subcutaneous injections of CBLB502 0.35 μg/kg (not more 30 μg/injection) or Placebo at Day 1 and Day 4 before tumor removal
Receives: Drug: CBLB502; Drug: Placebo
2 injections of CBLB502 0.45 μg/kgExperimentalTwo 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
Receives: Drug: CBLB502; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Baseline to up to 14 days after the drug administration

Secondary outcomes (9)

  1. Assessment of immune cells change in tumor by H&E and ICH staining

    Measured: On Day 7 (Surgery day) after the drug administration

  2. Determination of levels of cytokine IL-6 in blood by multiplex assays

    Measured: Baseline to up to 7 days after the drug administration

  3. Determination of levels of cytokine IL-8 in blood by multiplex assays

    Measured: Baseline to up to 7 days after the drug administration

  4. Determination of levels of cytokine IL-10 in blood by multiplex assays

    Measured: Baseline to up to 7 days after the drug administration

  5. Determination of levels of cytokine G-CSF in blood by multiplex assays

    Measured: Baseline to up to 7 days after the drug administration

  6. Determination of levels of cytokine TNFа in blood by multiplex assays

    Measured: Baseline to up to 7 days after the drug administration

  7. Specific T-cell responses measured by ELIspot

    Measured: Baseline to up to 14 days after the drug administration

  8. Antibody titer to CBLB502 as measured by ELISA

    Measured: Baseline and on day 14 after the drug administration

  9. Blood leukocytes by FACS

    Measured: Baseline to up to 7 days after the drug administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Mar 2016 (estimated)
  2. Study startNov 2015
  3. Primary completionFeb 2017 (estimated)
  4. Study completion31 Dec 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02715882
Sponsor's protocol ID
BL612-CBLB502
Status last verified
Jul 2016
First submitted
17 Mar 2016
Last updated
9 Feb 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CBLB502 in people with Colorectal Cancer, run by BioLab 612 LLC at 1 site in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02715882.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2017.

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