NCT02514213

Trial to Evaluate Safety and Immunogenicity of INO-5150 Alone or With INO-9012 in Men With Prostate Cancer

Phase I, Open-label Trial to Evaluate the Safety and Immunogenicity of INO-5150 Alone or in Combination With INO-9012 in Men With Biochemically Relapsed (PSA) Prostate Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Inovio Pharmaceuticals · Industry
• Sex: Male
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
BIOLOGICAL	2mg INO-5150 and electroporation device CELLECTRA®-5P	2mg INO-5150 delivered IM followed by electroporation using CELLECTRA®-5P
BIOLOGICAL	8.5mg INO-5150 and electroporation device CELLECTRA®-5P	8.5 mg INO-5150 delivered IM followed by electroporation using CELLECTRA®-5P
BIOLOGICAL	2mg INO-5150 plus 1mg INO-9012 and electroporation device CELLECTRA®-5P	2mg INO-5150 plus 1 mg INO9012 delivered IM followed by electroporation using CELLECTRA®-5P
BIOLOGICAL	8.5mg INO-5150 plus 1mg INO-9012 and electroporation device CELLECTRA®-5P	8.5mg INO-5150 plus 1 mg INO9012 delivered IM followed by electroporation using CELLECTRA®-5P
DEVICE	Electroporation using CELLECTRA®-5P	Electroporation device CELLECTRA®-5P

Timeline

• Start date: 2015-07-01
• Primary completion: 2017-12-12
• Completion: 2017-12-12
• First posted: 2015-08-03
• Last updated: 2017-12-26

Locations

10 sites across 1 country: United States