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

Study Overview

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

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.

Solid Organ Cancers

BIOLOGICAL: GL-ONC1

151060

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2016-03-02	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-08-02
First Submitted that Met QC Criteria 2016-03-15	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-08-06
First Posted (ACTUAL) 2016-03-21	Results First Posted N/A	Last Verified 2024-08

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: GL-ONC1 Cohort 3, 5, 7, 8, 9	BIOLOGICAL: GL-ONC1 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

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: GL-ONC1

Cohort 3, 5, 7, 8, 9

BIOLOGICAL: GL-ONC1

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

Primary Outcome Measures	Measure Description	Time Frame
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.	2.5 years

Secondary Outcome Measures	Measure Description	Time Frame
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	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	2.5 years
Level of anti-vaccinia neutralizing antibodies in serum	Level of anti-vaccinia neutralizing antibodies in serum	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	2.5 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Genelux Corporation

Investigators

PRINCIPAL_INVESTIGATOR: Kaitlyn Kelly, MD, University of California, San Diego

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record