GL-ONC1 Administered Intravenously Prior to Surgery to Patients With Solid Organ Cancers

Andrew Lowy

Status and phase

Terminated

Phase 1

Conditions

Solid Organ Cancers

Treatments

Biological: GL-ONC1

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02714374

151060

Details and patient eligibility

About

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.

Full description

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.

Enrollment

5 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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