Phase IIIa Study of EGFR-targeted Nanocell Therapy with Gemcitabine and Nab-paclitaxel in Metastatic Pancreatic Ductal Adenocarcinoma

What this Trial Is About

Researchers are evaluating a new treatment approach for people with metastatic pancreatic ductal adenocarcinoma PDAC who have progressed after initial therapy with certain chemotherapy combinations. The study focuses on assessing the safety, tolerability, and overall survival when adding an experimental therapy called E-EDV-D682GC to standard chemotherapy drugs gemcitabine and nab-paclitaxel. This trial is a randomized, blinded Phase IIIa study designed to compare this combination against gemcitabine and nab-paclitaxel alone. The experimental treatment includes two investigational products E-EDV-D682, which packages a chemotherapy agent targeted to cancer cells expressing EGFR, and EDV-GC, which aims to boost the bodys immune response. Participants receive these drugs alongside gemcitabine and nab-paclitaxel. The trial has two parts an initial safety phase with at least six participants receiving the experimental combination to check for side effects, followed by a randomized phase where participants are assigned either to the experimental combination or to standard chemotherapy with placebo. Treatment cycles involve bi-weekly then weekly visits, with tumor assessments every 8 weeks to monitor response. Participants will be involved for about six months, including screening, treatment, and follow-up. They will undergo regular clinical visits, imaging scans to measure tumor burden, and safety assessments throughout the study and for up to 30 days after treatment ends. Researchers will monitor adverse events and overall survival, as well as measure disease progression and response using established imaging criteria. The study also includes a safety follow-up period to closely track participants health after treatment.

A Clinical Trial to Evaluate EDV Nanocell Therapy With Gemcitabine and Nab-paclitaxel in Pancreatic Cancer