The purpose of this study is to evaluate the safety of the investigational product GL-ONC1. GL-ONC1, a vaccinia virus, has been genetically modified for use as a potential anti-cancer drug to destroy cancer cells. Vaccinia virus has been used successfully in the past as smallpox vaccine in millions of people worldwide.
This is an open-label, non-randomized Phase 1b dose escalation study evaluating the safety and effect of the oncolytic virus GL-ONC1 administered intravenously, with or without eculizumab, prior to surgery in patients with advanced solid organ tumors. GL-ONC1 is a genetically engineered oncolytic vaccinia virus, which disrupts nonessential genes and expression of the foreign gene expression. Evidence suggest that GL-ONC1 is able to infect tumor tissue and kill tumor cells. The goals of this study are to evaluate the safety of GL-ONC1 and to assess the pharmacokinetics and pharmacodynamics profile of GL-ONC1 in vivo.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
5
Dose and Regimen: 1. Single dose group: Cohort 1 dose is 1 × 109 pfu 2. Multiple dose groups: * Cohort 2 dose is 1 × 109 pfu × 5 consecutive days * Cohorts 3 and 4 dose is 2 × 109 pfu × 5 consecutive days * Cohorts 5 and 6 dose escalates at 2,3,5,5,5 × 109 pfu. Route: GL-ONC1 is delivered as a bolus IV injection.
UC San Diego Moores Cancer Center
La Jolla, California, United States
Number of participants with treatment-related adverse events as defined by CTCAE v4.03.
Number of participants with treatment-related adverse events as defined by CTCAE v4.03.
Time frame: 2.5 years
The presence of GL-ONC1 within malignant tumors by examination of the resected surgical specimen.
The presence of GL-ONC1 within malignant tumors by examination of the resected
Time frame: 2.5 years
The maximum concentration (Cmax) of GL-ONC1 in blood after administration
The maximum concentration (Cmax) of GL-ONC1 in blood after administration
Time frame: 2.5 years
Level of anti-vaccinia neutralizing antibodies in serum
Level of anti-vaccinia neutralizing antibodies in serum
Time frame: 2.5 years
Amount of lymphocyte infiltration in pre-treatment biopsy and post-treatment resected tumor tissue
Amount of lymphocyte infiltration in pre-treatment biopsy and post-treatment resected
Time frame: 2.5 years
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