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

Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02715882
• Other study ID #: BL612-CBLB502
• Status: Active, not recruiting
• Phase: Phase 2
• First received: March 17, 2016
• Last updated: February 8, 2017
• Start date: November 2015
• Est. completion date: December 31, 2017

Study information

• Verified date: July 2016
• Source: BioLab 612 LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: December 31, 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 ? and ?, 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 Inform?d 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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• CBLB502

• Placebo

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
BioLab 612 LLC	Cleveland BioLabs, Inc.

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Assessment of immune cells change in tumor by H&E and ICH staining		On Day 7 (Surgery day) after the drug administration
Secondary	Determination of levels of cytokine IL-6 in blood by multiplex assays		Baseline to up to 7 days after the drug administration
Secondary	Determination of levels of cytokine IL-8 in blood by multiplex assays		Baseline to up to 7 days after the drug administration
Secondary	Determination of levels of cytokine IL-10 in blood by multiplex assays		Baseline to up to 7 days after the drug administration
Secondary	Determination of levels of cytokine G-CSF in blood by multiplex assays		Baseline to up to 7 days after the drug administration
Secondary	Determination of levels of cytokine TNF? in blood by multiplex assays		Baseline to up to 7 days after the drug administration
Secondary	Specific T-cell responses measured by ELIspot		Baseline to up to 14 days after the drug administration
Secondary	Antibody titer to CBLB502 as measured by ELISA		Baseline and on day 14 after the drug administration
Secondary	Blood leukocytes by FACS		Baseline to up to 7 days after the drug administration