Phase III Study of Mesenchymal Stromal Cell-Derived Exosomes Carrying KrasG12D siRNA for Treating Metastatic Pancreatic Cancer with KrasG12D Mutation

What this Trial Is About

Researchers are evaluating a treatment called mesenchymal stromal cells-derived exosomes loaded with KrasG12D siRNA iExosomes for people with metastatic pancreatic ductal adenocarcinoma PDAC that has spread and carries the KrasG12D mutation. This phase I study aims to find the best dose and understand the side effects of iExosomes. The study also explores how the treatment affects disease control, overall survival, and progression-free survival in these patients. Participants receive iExosomes intravenously over 15 to 20 minutes on days 1, 4, and 10 of each 14-day cycle. This treatment continues for up to three cycles if the disease does not worsen or side effects are unacceptable. Patients who respond to treatment may receive up to three additional cycles. Optional tissue and blood samples may be collected to study the presence of KrasG12D mutation and siRNA content. During the study, participants are closely monitored with evaluations including safety, response to treatment, and survival outcomes. Follow-up visits occur 30 days after treatment ends and then every 3 months for up to one year. Researchers measure dose-limiting toxicities, maximum tolerated dose, minimal residual disease, overall survival, and progression-free survival to understand the treatments impact and safety.

iExosomes in Treating Participants With Metastatic Pancreas Cancer With KrasG12D Mutation