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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03393884 | Study of IMNN-001 (Also Known as GEN-1) With NACT for Treatment of Ovarian Cancer (OVATION 2) | PHASE1 | ACTIVE NOT_RECRUITING | 130 | — | — | Sep 5, 2018 | May 30, 2026 | May 4, 2026 | 21 | United States, Canada |
| NCT02480374 | Study of Safety & Biological Activity of IP IMNN-001 (also Known As GEN-1) with Neoadjuvant Chemo in Ovarian Cancer | PHASE1 | COMPLETED | 18 | — | — | Sep 1, 2015 | May 1, 2017 | Oct 2, 2024 | 4 | United States |
The primary objective of the study is to evaluate safety and compare progression free survival between subjects receiving neoadjuvant chemotherapy (NACT) plus IMNN-001 versus standard NACT.
Dose-limiting toxicity
| Arm | Type | Description |
|---|---|---|
| NACT + IMNN-001 | EXPERIMENTAL | The NACT regimen will be paclitaxel 175 mg/m2 IV over 3 hours followed by carboplatin AUC 6 IV over 1 hour on Day 1. This will be repeated every 3 weeks for 6 cycles. IMNN-001 100 mg/m2 IP will be administered on Days 8 and 15 of the first NACT cycle and then on Days 1, 8, and 15 of the subsequent 21 day NACT cycles for a total of 17 treatments. |
| NACT Alone | ACTIVE_COMPARATOR | The NACT regimen will be paclitaxel 175 mg/m2 IV over 3 hours followed by carboplatin AUC 6 IV over 1 hour on Day 1. This will be repeated every 3 weeks for 6 cycles. |
| Single Arm | EXPERIMENTAL | Carboplatin + Paclitaxel + IMNN-001 |
| Name | Type | Description |
|---|---|---|
| IMNN-001 | BIOLOGICAL | IL-12 Plasmid Formulated with PEG-PEI-Cholesterol Lipopolymer |
| Carboplatin | DRUG | AUC 6 IV over 1 hour on Day 1 of each cycle |
| Paclitaxel | DRUG | 175 mg/m2 IV over 3 hours on Day 1 of each cycle |
Inclusion Criteria: 1. Patients must have suspected histologic diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal carcinoma per pre-treatment biopsies by laparoscopy, or interventional radiology or CT guided core biopsy. Histologic documentation of the original primary tumor is ...