Safety and Effect of GL-ONC1 Administered IV Prior to Surgery to Patients With Solid Organ Cancers Undergoing Surgery
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ClinicalTrials.gov Identifier: NCT02714374 |
Recruitment Status :
Terminated
(Insufficient funding)
First Posted : March 21, 2016
Last Update Posted : March 25, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Solid Organ Cancers | Biological: GL-ONC1 | Phase 1 |
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 (Clinical Trial) |
Actual Enrollment : | 5 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Actual Study Start Date : | March 25, 2016 |
Actual Primary Completion Date : | August 6, 2019 |
Actual Study Completion Date : | August 6, 2019 |

Arm | Intervention/treatment |
---|---|
Experimental: GL-ONC1
Cohort 3, 5, 7, 8, 9
|
Biological: GL-ONC1
Dose and Regimen:
Route: GL-ONC1 is delivered as a bolus IV injection. |
- 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. [ 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02714374
United States, California | |
UC San Diego Moores Cancer Center | |
La Jolla, California, United States, 92093 |
Principal Investigator: | Kaitlyn Kelly, MD | University of California, San Diego |
Responsible Party: | Kaitlyn Kelly, MD, Assistant Clinical Professor, University of California, San Diego |
ClinicalTrials.gov Identifier: | NCT02714374 |
Other Study ID Numbers: |
151060 |
First Posted: | March 21, 2016 Key Record Dates |
Last Update Posted: | March 25, 2020 |
Last Verified: | March 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
GL-ONC1 Solid Organ Cancer Cancer Surgery Oncolytic Virus Soliris Metastatic melanoma Esophageal and gastric adenocarcinoma (Stage III/IV) Cholangiocarcinoma |
Pancreatic adenocarcinoma Gallbladder cancer Colorectal cancer (Stage IV) High-grade mucinous appendix cancer High-grade gastrointestinal neuroendocrine cancer Mesothelioma High-grade soft tissue sarcoma Stage III or IV |