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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05673811 | Study of Nab-Paclitaxel and Gemcitabine and Plus/Minus VCN-01 in Patients With Metastatic Pancreatic Cancer | PHASE2 | COMPLETED | 112 | — | — | Jan 10, 2023 | Mar 28, 2025 | Apr 16, 2025 | 17 | United States, Spain |
Time from randomization until death in both arms
Safety and tolerability of VCN-01, IV administered at Week 1 and Week 14 in Arm 2 measured as incidence of Adverse Events as assessed by CTCAE v5.0
| Arm | Type | Description |
|---|---|---|
| Arm 1-SoC | ACTIVE_COMPARATOR | Nab-paclitaxel and gemcitabine as SoC. |
| Arm 2 -VCN-01 + SoC | EXPERIMENTAL | A maximum of two (2) doses of VCN-01 administrated as a single IV infusion in combination with nab-paclitaxel and gemcitabine as SoC. |
| Name | Type | Description |
|---|---|---|
| Nab-paclitaxel | DRUG | Nab-paclitaxel administered as an IV infusion at a rate of 125 mg/m2. Nab-paclitaxel is administered on Day 1, Day 8 and Day 15 of each 28-day cycles. |
| Gemcitabine | DRUG | Gemcitabine administered as an IV infusion at a dose of 1,000 mg/m2 immediately after the completion of nab-paclitaxel administration as part of SoC. Gemcitabine is administered on Day 1, Day 8 and Day 15 of each 28-day cycles. |
| VCN-01 | GENETIC | VCN-01 administrated as a single IV infusion at dose 1xE13 viral particles (vp) on Day 1 of the 1st cycle and then again on Day 1 of the 4th cycle (Day 92). On cycle 1 and cycle 4, nab-paclitaxel and gemcitabine administered on Day 8, Day 15 and Day 22. |
Inclusion Criteria: 1. Written informed consent obtained prior to any study-specific procedures or assessments. 2. Male/female patients aged 18 years or over. 3. Patients with histologically or cytologically confirmed, first line metastatic pancreatic adenocarcinoma stage IV de novo, who never rece...