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.
|First Received Date||March 2, 2016|
|Last Changed Date||June 26, 2017|
|Start Date||March 2016|
|Anticipated Primary Completion Date||March 2019|
|Primary Outcome Measures||
Number of participants with treatment-related adverse events as defined by CTCAE v4.03. [Time Frame: 2.5 years]
|Secondary Outcome Measures||
The presence of GL-ONC1 within malignant tumors by examination of the resected surgical specimen. [Time Frame: 2.5 years]
The maximum concentration (Cmax) of GL-ONC1 in blood after administration [Time Frame: 2.5 years]
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 [Time Frame: 2.5 years]
|Study Arms / Comparison Groups||1 / 0|
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.
|Recruitment Status||Active, not recruiting|
|Ages||18 Years - N/A|
|Accepts Healthy Volunteers||No|
- 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
|Sponsor||Kaitlyn Kelly, MD|
|Verification Date||June 2017|