Suspended

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

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What is being tested

GL-ONC1

Biological
Who is being recruted

Adenocarcinoma+29

+ Adenoma

+ Biliary Tract Diseases

Over 18 Years
+21 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: March 2016
See protocol details

Summary

Principal SponsorAndrew Lowy
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 25, 2016

Actual date on which the first participant was enrolled.

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.

Official TitleAn 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
NCT02714374
Principal SponsorAndrew Lowy
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

5 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AdenocarcinomaAdenomaBiliary Tract DiseasesBiliary Tract NeoplasmsCarcinomaColonic DiseasesDigestive System DiseasesDigestive System NeoplasmsGallbladder DiseasesGallbladder NeoplasmsGastrointestinal DiseasesGastrointestinal NeoplasmsIntestinal DiseasesIntestinal NeoplasmsMelanomaMesotheliomaNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueRectal DiseasesSkin DiseasesSkin NeoplasmsColorectal NeoplasmsSkin and Connective Tissue DiseasesNeuroectodermal TumorsCholangiocarcinomaNeoplasms, MesothelialNevi and MelanomasNeuroendocrine Tumors

Criteria

9 inclusion criteria required to participate
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.
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12 exclusion criteria prevent from participating
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.
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Cohort 3, 5, 7, 8, 9

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

UC San Diego Moores Cancer Center

La Jolla, United StatesOpen UC San Diego Moores Cancer Center in Google Maps
SuspendedOne Study Center