Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
INO-5150 and electroporation device CELLECTRA-5P · 1 trial · 1 indication
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 .
Antigen specific cellular immune responses
| Arm | Type | Description |
|---|---|---|
| Arm A | EXPERIMENTAL | 2mg INO-5150 and electroporation device CELLECTRA®-5P |
| Arm B | EXPERIMENTAL | 8.5mg INO-5150 and electroporation device CELLECTRA®-5P |
| Arm C | EXPERIMENTAL | 2mg INO-5150 plus 1mg INO-9012 and electroporation device CELLECTRA®-5P |
| Arm D | EXPERIMENTAL | 8.5mg INO-5150 plus 1mg INO-9012 and electroporation device CELLECTRA®-5P |
| Name | Type | Description |
|---|---|---|
| 2mg INO-5150 and electroporation device CELLECTRA®-5P | BIOLOGICAL | 2mg INO-5150 delivered IM followed by electroporation using CELLECTRA®-5P |
| 8.5mg INO-5150 and electroporation device CELLECTRA®-5P | BIOLOGICAL | 8.5 mg INO-5150 delivered IM followed by electroporation using CELLECTRA®-5P |
| 2mg INO-5150 plus 1mg INO-9012 and electroporation device CELLECTRA®-5P | BIOLOGICAL | 2mg INO-5150 plus 1 mg INO9012 delivered IM followed by electroporation using CELLECTRA®-5P |
| 8.5mg INO-5150 plus 1mg INO-9012 and electroporation device CELLECTRA®-5P | BIOLOGICAL | 8.5mg INO-5150 plus 1 mg INO9012 delivered IM followed by electroporation using CELLECTRA®-5P |
| Electroporation using CELLECTRA®-5P | DEVICE | Electroporation device CELLECTRA®-5P |
Inclusion Criteria: 1. Men aged 18 to 90 years with a histologic diagnosis of prostate cancer; 2. c. Biochemical recurrence following local therapy, either surgery or radiation. Rising PSA defined as: * After definitive surgery, e.g. * After radical prostatectomy, two PSA measurements of ...
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INO-5150 and electroporation device CELLECTRA-5P is an investigational therapy studied in men with prostate cancer. It was evaluated in a Phase 1 clinical trial that enrolled 62 participants in the United States. The study assessed the combination in adults 18 years and older.
INO-5150 and electroporation device CELLECTRA-5P is being developed by Inovio Pharmaceuticals, Inc., which trades under the ticker INO. The company sponsored the Phase 1 study of the therapy in prostate cancer.
INO-5150 and electroporation device CELLECTRA-5P is in Phase 1 clinical development. The single Phase 1 trial, NCT02514213, has been completed. The therapy is investigational and has not been approved by the FDA for any indication.
INO-5150 and electroporation device CELLECTRA-5P was studied in the Phase 1 trial NCT02514213, titled Trial to Evaluate Safety and Immunogenicity of INO-5150 Alone or With INO-9012 in Men With Prostate Cancer. The trial enrolled 62 male participants in the United States and is completed.