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Safety and Effect of GL-ONC1 Administered IV With or Without Eculizumab Prior to Surgery to Patients With Solid Organ Cancers Undergoing Surgery

Estimated reading time: < 1 min

Condition

Solid Organ Cancers

Estimated Enrollment: 36

Age Group: 18 Years and older   (Adult, Senior)

Gender: All

Study Type: Interventional

Study Design Allocation: Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: Open Label|Primary Purpose: Treatment

Study ID Numbers: 151060

Study First Received: March 2, 2016

Last Updated: June 17, 2016

Estimated Primary Completion Date: March 2018

Primary Outcome Measures:

Number of participants with treatment-related adverse events as defined by CTCAE v4.03.|The presence of GL-ONC1 within malignant tumors by examination of the resected surgical specimen.|The maximum concentration (Cmax) of GL-ONC1 in blood after administration|Level of anti-vaccinia neutralizing antibodies in serum|Amount of lymphocyte infiltration in pre-treatment biopsy and post-treatment resected tumor tissue

Sponsors and Collaborators:

Kaitlyn Kelly, MD|Genelux Corporation|University of California, San Diego

Result Received: No Study Results Posted

Website Link: https://ClinicalTrials.gov/show/NCT02714374

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