This is a phase I, open-label trial to evaluate the safety and immunogenicity of INO 5150 alone or in combination with INO-9012 when delivered intramuscularly (IM) followed by electroporation (EP) in men with biochemically relapsed prostate cancer.
Phase I, open label study of INO-5150 (DNA plasmids encoding prostate specific antigen (PSA) and prostate specific membrane antigen (PSMA)) alone or co-administered with INO-9012 (IL-12 plasmid) delivered intramuscularly followed by EP using the CELLECTRA®-5P device in adult males with biochemically relapsed prostate cancer following definitive local therapy (e.g. prostatectomy, external beam radiation, or brachytherapy). Four injections will be administered to approximately 60 eligible subjects who consent to participate in the study. Subjects will be monitored for safety and immunogenicity through Week 72.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
62
2mg INO-5150 delivered IM followed by electroporation using CELLECTRA®-5P
8.5 mg INO-5150 delivered IM followed by electroporation using CELLECTRA®-5P
2mg INO-5150 plus 1 mg INO9012 delivered IM followed by electroporation using CELLECTRA®-5P
Chesapeake Urology Research Associates
Baltimore, Maryland, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
GU Research Network, LLC/ Urology Cancer Center
Omaha, Nebraska, United States
Safety and tolerability of INO-5150 alone or with INO-9012 delivered via IM EP ( Incidence of adverse events, Injection site reactions, Changes in safety laboratory parameters)
1. Incidence of adverse events (all, severe, \[NCI CTCAE v4.03\] and serious) classified by system organ class (SOC), preferred term, severity, and relationship to study medication and schedule 2. Injection site reactions 3. Changes in safety laboratory parameters .
Time frame: 72 weeks
Antigen specific immune response of INO-5150 alone or with INO-9012 delivered via IM EP
Antigen specific cellular immune responses
Time frame: 72 weeks
PSA response rate by PSA testing
PSA response
Time frame: 72 weeks
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8.5mg INO-5150 plus 1 mg INO9012 delivered IM followed by electroporation using CELLECTRA®-5P
Electroporation device CELLECTRA®-5P
Weill Cornell Medical College
New York, New York, United States
University of North Carolina Lineberger Cancer Center
Chapel Hill, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
Sidney Kimmel Cancer Center - Thomas Jefferson University
Philadelphia, Pennsylvania, United States
UPMC
Pittsburgh, Pennsylvania, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States