Safety and Effect of GL-ONC1 Administered IV Prior to Surgery to Patients With Solid Organ Cancers Undergoing Surgery
|Study Design:||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|
- 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 ]
|Study Start Date:||March 2016|
|Estimated Study Completion Date:||March 2021|
|Estimated Primary Completion Date:||March 2019 (Final data collection date for primary outcome measure)|
Cohort 3, 5, 7, 8, 9
Dose and Regimen:
Route: GL-ONC1 is delivered as a bolus IV injection.
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|