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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04398433 | INO-3107 With Electroporation (EP) in Participants With HPV-6- and/or HPV-11-Associated Recurrent Respiratory Papillomatosis (RRP) | PHASE1 | COMPLETED | 32 | — | — | Oct 7, 2020 | Dec 15, 2022 | Apr 14, 2026 | 11 | United States |
An adverse event (AE) was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. SAEs were any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in congenital anomaly or birth defect, or was considered an important medical event. TEAEs were defined for this trial as any AEs that occurred following Day 0 following administration of study drug (IM + EP), until 30 days following the last dose. TEAEs included both serious and non-serious TEAEs.
| Arm | Type | Description |
|---|---|---|
| INO-3107: Group 1 | EXPERIMENTAL | Participants who had less than or equal to (≤) 2 surgeries received 6.25 milligrams per milliliter (mg/mL) INO-3107, intramuscular (IM) injection, followed by electroporation (EP) using CELLECTRA® 2000 at Day 0, Week 3, Week 6, and Week 9. |
| INO-3107: Group 2 | EXPERIMENTAL | Participants who had 3-5 surgeries received 6.25 mg/mL INO-3107, IM injection, followed by EP using CELLECTRA® 2000 at Day 0, Week 3, Week 6, and Week 9. |
| INO-3107: Group 3 | EXPERIMENTAL | Participants who had more than or equal to (≥) 6 surgeries received 6.25 mg/mL INO-3107, IM injection, followed by EP using CELLECTRA® 2000 at Day 0, Week 3, Week 6, and Week 9. |
| Name | Type | Description |
|---|---|---|
| INO-3107 | DRUG | INO-3107 administered by IM injection. |
| CELLECTRA® 2000 | DEVICE | CELLECTRA® 2000 device used for EP following IM delivery of INO-3107. |
Key Inclusion Criteria: * Histologically-documented HPV-6- or HPV-11-positive respiratory papilloma or documentation of low-risk positive HPV using a Sponsor approved HPV-6/11 type-specific assay * Requirement for frequent RRP intervention to remove or resect respiratory papilloma, as defined as at...