Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02960594 | hTERT Immunotherapy Alone or in Combination With IL-12 DNA Followed by Electroporation in Adults With Solid Tumors at High Risk of Relapse | PHASE1 | COMPLETED | 93 | — | — | Dec 1, 2014 | Nov 9, 2018 | Nov 19, 2018 | 6 | United States |
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | 2 mg INO-1400 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12 |
| Arm 2 | EXPERIMENTAL | 8 mg INO-1400 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12 |
| Arm 3 | EXPERIMENTAL | 2 mg INO-1400 + 0.5 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12 |
| Arm 4 | EXPERIMENTAL | 2 mg INO-1400 + 2 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12 |
| Arm 5 | EXPERIMENTAL | 8 mg INO-1400 + 0.5 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12 |
| Arm 6 | EXPERIMENTAL | 8 mg INO-1400 + 2 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12 |
| Arm 7 | EXPERIMENTAL | 2 mg INO-1401 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12 |
| Arm 8 | EXPERIMENTAL | 8 mg INO-1401 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12 |
| Arm 9 | EXPERIMENTAL | 8 mg INO-1401 + 0.5 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12 |
| Arm 10 | EXPERIMENTAL | 8 mg INO-1401 + 2 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12 |
| Name | Type | Description |
|---|---|---|
| INO-1400 | BIOLOGICAL | - |
| INO-9012 | BIOLOGICAL | - |
| INO-1401 | BIOLOGICAL | - |
Inclusion Criteria: * 1\. Signed and dated written IRB approved informed consent; * 2\. Males or females aged ≥18 years; * 3\. Subjects with breast, lung or pancreatic carcinoma who are at high risk of relapse post definitive therapy at least 4 and no more than 24 weeks from completion of definitiv...