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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07059611 | Neoadjuvant Intra-tumoral RP2 and FLOT in Gastroesophageal Adenocarcinoma | PHASE2 | NOT YET_RECRUITING | 34 | — | — | Sep 1, 2026 | Nov 1, 2029 | Jun 5, 2026 | 1 | United States |
Pathologic complete response defined as the absence of residual invasive cancer on histologic examination of the resected esophageal, GEJ, or gastric adenocarcinoma specimen and all sampled regional lymph nodes. This will be assessed in the efficacy population who received at least three intra-tumoral injections of RP2 and underwent subsequent surgical resection.
| Arm | Type | Description |
|---|---|---|
| RP2 and FLOT | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| RP2 | BIOLOGICAL | Upper endoscopy with RP2 intra-tumoral injection of 1 x 10(6) plaque forming units (PFU)/mL for first intra-tumoral injection, up to 10mL of 1x107 PFU/mL of RP2 for subsequent intra-tumoral injections. Injection will occur within 4 days prior of each cycle FLOT. |
| 5-Fluorouracil | COMBINATION_PRODUCT | 5-Fluorouracil as part of the FLOT regimen 2,600mg/m2 intravenous infusion over 24 hours on day 1 of each 14-day cycle for 4 cycles. |
| Leucovorin | COMBINATION_PRODUCT | Leucovorin as part of the FLOT regimen 200mg/m2 intravenous infusion on day 1 of a 14-day cycle for 4 cycles. |
| Oxaliplatin | COMBINATION_PRODUCT | Oxaliplatin as part of the FLOT regimen 85mg/m2 intravenous infusion on day 1 of a 14-day cycle for 4 cycles. |
| Docetaxel | COMBINATION_PRODUCT | Docetaxel as part of the FLOT regimen 50mg/m2 intravenous infusion on day 1 of a 14-day cycle for 4 cycles. |
| Pegfilgrastim | DRUG | Pegfilgrastim or Filgrastim is required on the study and should be administered per the package insert of the commercially obtained drug following each cycle of FLOT for 4 cycles. |
| Filgrastim | DRUG | Filgrastim or Pegfilgrastim is required on the study and should be administered per the package insert of the commercially obtained drug following each cycle of FLOT for 4 cycles. |
| Surgical Resection of Primary Tumor | PROCEDURE | Following 4 cycles of preoperative FLOT with RP2 injections, surgical resection of esophageal, GEJ, or gastric primary tumor per standard of care practice. |
Inclusion Criteria: * Patients must have histologically confirmed and clinically staged T2 or higher or node positive, non-metastatic esophageal, gastroesophageal junction, or gastric adenocarcinoma. * Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1. * Pa...