NCT07049055 A Clinical Trial to Evaluate EDV Nanocell Therapy With Gemcitabine and Nab-paclitaxel in Pancreatic Cancer
| NCT ID | NCT07049055 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Engeneic Pty Limited |
| Condition | Pancreatic Cancer, Metastatic |
| Study Type | INTERVENTIONAL |
| Enrollment | 144 participants |
| Start Date | 2026-01-12 |
| Primary Completion | 2028-09 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
The purpose of this study is to evaluate the safety and tolerability and overall survival (OS) of E-EDV-D682/GC in combination with gemcitabine and nab-paclitaxel versus gemcitabine and nab-paclitaxel alone in participants with metastatic pancreatic ductal adenocarcinoma (PDAC) who have progressed on therapy.
Eligibility Criteria
Inclusion Criteria: * Histological or pathological confirmation of metastatic pancreas adenocarcinoma. Cytological or histological evidence of metastatic disease is required. * Male or Female greater than or equal to 18 years of age. * Eastern Cooperative Oncology Group (ECOG) performance score of 0-1. * Life expectancy ≥ 3 months in the opinion of the Investigator. * Measurable disease as per iRECIST criteria. * Subjects must have tumors that express EGFR. * Documented disease progression with first line FOLFIRINOX or NALIRIFOX therapy, during or within 3 months (+/- 15 days) after end of therapy. * No more than one line of prior systemic therapy for metastatic PDAC allowed. * Albumin level \> 3.0 g/dl * Adequate hematological function. * Adequate renal function. * Adequate hepatic function. * Adequate cardiac function with LVEF ≥ 50% at baseline. * Reproductive criteria as follows: * Female subjects who are of non-reproductive potential * Female subjects of childbearing potential mus
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