A Multicenter, Open Label, Uncontrolled Phase I Trial to Compare Safety, Tolerability and Immunogenicity of Vx-006 Vaccine at 0.5mg, 1mg, 5mg and 10mg Doses in Human Leukocyte Antigen-A02 (HLA-A02) Positive Patients With Solid Tumours

Vaxon Biotech3 sites in 1 country23 target enrollmentMarch 2014

ConditionsSolid Tumor

DrugsVx-006: 0,5mg Vx-006: 1mg Vx-006: 5mg Vx-006: 10mg

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Solid Tumor
Sponsor: Vaxon Biotech
Enrollment: 23
Locations: 3
Primary Endpoint: Adverse event number by treatment group as a measure of safety and tolerability
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Patients with histologically proven malignancy with documented disease control (objective response or stable disease) or Not Evaluable Disease (NED) expectancy > 6 months; only HLA-A*02 positive patients.

The primary objective of the trial is to compare safety and tolerability of four different doses of Vx-006. The secondary objective is to compare immunogenicity of four different doses of the Vx-006.

Registry

clinicaltrials.gov

Start Date

March 2014

End Date

May 2017

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Vaxon Biotech

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female \> or = 18 years of age;
•Histologically proven malignancy;
•Documented HLA-A\*02 positivity, as determined by a central laboratory;
•Disease control (Complete Response (CR), Partial Response (PR), or Stable Disease (SD)) according to Response Evaluation Criteria In Solid Tumors (RECIST 1.1) criteria or NED in the case of patients who received adjuvant chemotherapy
•Patient with disease control or NED expectancy \> or = 6 months according to investigator opinion;
•ECOG performance status 0, 1;
•Patients must have adequate renal and hepatic function as assessed by standard laboratory criteria;
•Patients must have adequate haematological function:
•Platelet count \> or = 100 x 109/L;
•White Blood Cell (WBC) count \> or = 2.5 x 109/L;

Exclusion Criteria

•Prior treatment with cancer vaccines;
•Treatment with immunotherapy (e.g., interferons, interleukins, Tumor Necrosis Factor (TNF), or biological response modifiers, such as Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) etc) within four weeks prior to the first vaccination;
•Treatment with immunosuppressive agents (including corticosteroids) within 2 weeks prior to the first vaccination;
•Treatment with any investigational drugs, within 4 weeks prior to the first vaccination;
•Autoimmune or immunodeficiency disease that in the opinion of the investigator may compromise the safety of the patient in the study;
•Any pre-existing medical condition requiring concomitant systemic corticosteroid or immunosuppressive therapy. The use of inhaled corticosteroids for Chronic Obstructive Pulmonary Disease (COPD) or topical steroids is allowed;
•Known hepatitis B and/or C infection documented in patient files, testing not required;
•Known HIV-positivity, testing not required;
•Clinically significant hepatic dysfunction (Alanine amino transferase (ALT)\>2.5 times normal upper limits \[ULN\], Aspartate Amino Transferase (AST)\>2.5 times Upper Limit of Normal (ULN), bilirubin\>1.5 times ULN);
•Clinically significant renal dysfunction (serum creatinine\>1.5 time ULN);

Outcomes

Primary Outcomes

Adverse event number by treatment group as a measure of safety and tolerability

Time Frame: 18 Weeks

The following parameters of safety and tolerability will be assessed: * Physical examination and vital signs (blood pressure, pulse rate, body temperature, weight, height (only at baseline), * Electrocardiogram, * Adverse event evaluation, * Eastern Cooperative Oncology Group (ECOG) performance status, * Clinical laboratory evaluation: haematology and clinical chemistry * Collection of concomitant medication