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

NCT02715882 | Unknown Phase 2

• 1 other identifier: BL612-CBLB502
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Colorectal Cancer

Keywords

Colorectal cancer; TLR5; Immunotherapy

Outcome Measures

Primary Outcomes (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

  Baseline to up to 14 days after the drug administration

Secondary Outcomes (9)

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

  On Day 7 (Surgery day) after the drug administration

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

  Baseline to up to 7 days after the drug administration

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

  Baseline to up to 7 days after the drug administration

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

  Baseline to up to 7 days after the drug administration

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

  Baseline to up to 7 days after the drug administration

Study Arms (4)

1 injection of CBLB502 0.35 μg/kg

EXPERIMENTAL

One subcutaneous injection of CBLB502 0.35 μg/kg (not more 30 μg/injection) or Placebo at Day 1 before tumor removal

Drug: CBLB502; Drug: Placebo

1 injection of CBLB502 0.45 μg/kg

EXPERIMENTAL

One subcutaneous injection of CBLB502 0.45 μg/kg (not more 40 μg /injection) or Placebo at Day 1 before tumor removal

Drug: CBLB502; Drug: Placebo

2 injections of CBLB502 0.35 μg/kg

EXPERIMENTAL

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: CBLB502; Drug: Placebo

2 injections of CBLB502 0.45 μg/kg

EXPERIMENTAL

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: CBLB502; Drug: Placebo

Interventions

CBLB502 DRUG

Also known as: Entolimod

1 injection of CBLB502 0.35 μg/kg; 1 injection of CBLB502 0.45 μg/kg; 2 injections of CBLB502 0.35 μg/kg; 2 injections of CBLB502 0.45 μg/kg

Placebo DRUG

Also known as: PBS, Phosphate buffer saline

1 injection of CBLB502 0.35 μg/kg; 1 injection of CBLB502 0.45 μg/kg; 2 injections of CBLB502 0.35 μg/kg; 2 injections of CBLB502 0.45 μg/kg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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,
• 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

You may not qualify if:

• 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,
• 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:
• 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%

Sponsors & Collaborators

• BioLab 612 LLC: lead
• Cleveland BioLabs, Inc.: collaborator

Study Sites (1)

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

Moscow, Russia

Location

Related Links

• Related Info

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

CBLB502

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2016
• First Posted: March 22, 2016
• Study Start: November 1, 2015
• Primary Completion: February 1, 2017
• Study Completion: December 31, 2017
• Last Updated: February 9, 2017

Record last verified: 2016-07

Locations

RU (1)