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

NCT02714374 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2024-08-06

No results posted yet for this study

Summary

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.

Conditions

  • Solid Organ Cancers

Interventions

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 2,3,5,5,5 × 109 pfu. Route: GL-ONC1 is delivered as a bolus IV injection.

Sponsors & Collaborators

  • Genelux Corporation

    collaborator INDUSTRY

  • Andrew Lowy

    lead OTHER

Principal Investigators

  • Kaitlyn Kelly, MD · University of California, San Diego

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-25
Primary Completion
2019-08-06
Completion
2019-08-06
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02714374 on ClinicalTrials.gov