Safety and Effect of GL-ONC1 Administered IV Prior to Surgery to Patients With Solid Organ Cancers Undergoing Surgery



Status:Active, not recruiting
Healthy:No
Age Range:18 - Any
Updated:6/28/2017
Start Date:March 2016
End Date:March 2021

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An Open Label, Non-randomized Phase 1b Study to Investigate the Safety and Effect of the Oncolytic Virus GL-ONC1 Administered Intravenously Prior to Surgery to Patients With Solid Organ Cancers Undergoing Surgery for Curative-Intent or Palliative Resection

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.

Inclusion Criteria:

- Histologically-proven diagnosis of advanced (AJCC, 7th Edition: stage III or IV) or
aggressive solid organ cancer.

- Patients must provide written consent for a core needle biopsy sample of tumor tissue
(primary or metastatic).

- Have evidence of measurable disease (according to RECIST Version 1.1: http://
www.recist.com).

- Have an ECOG Performance Score of 0 to 2.

- Have a life expectancy of at least 3 months.

- Have adequate organ and marrow function

- Negative serum pregnancy test for females of childbearing potential.

- Have negative test result for HIV and Hepatitis B or C testing.

- Have baseline anti-vaccinia antibody titer < 10.

Exclusion Criteria:

- Current or anticipated use of other investigational agents or marketed anticancer
agent while on study (from the time of enrollment through the time of surgery).

- Patients who have received chemotherapy or radiotherapy within 4 weeks prior to
entering the study.

- Small pox vaccination for 4 weeks before study therapy and during study treatment.

- Have received prior gene therapy or therapy with cytolytic virus of any type.

- Have clinically significant cardiac disease

- Oxygen saturation <90% measured by pulse oximetry at rest.

- Receiving concurrent antiviral agent active against vaccinia virus (e.g., cidofovir,
vaccinia immunoglobulin, imatinib, ST-246) during the course of study.

- Have known allergy to ovalbumin or other egg products.

- Have clinically significant dermatological disorders (e.g., eczema, psoriasis, or any
unhealed skin wounds or ulcers)

- Have a history of allergy to iodinated contrast media.

- Patients with known brain metastases

- Pregnant or nursing
We found this trial at
1
site
3855 Health Sciences Dr,
La Jolla, California 92093
(858) 822-6100
UC San Diego Moores Cancer Center Established in 1978, UC San Diego Moores Cancer Center...
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mi
from
La Jolla, CA
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