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 : Active, not recruiting
First Posted : March 21, 2016
Last Update Posted : June 27, 2017
|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)|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||March 2016|
|Estimated Primary Completion Date :||March 2019|
|Estimated Study Completion Date :||March 2021|
Cohort 3, 5, 7, 8, 9
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 ]
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|