drugset / Trial / NCT07353645

KRAS Neoantigen Nanovaccine as Adjuvant Therapy for Colorectal Cancer/Pancreatic Cancer

NCT07353645

NaSingle-groupOpen-labelTreatment

Summary

This clinical trial will utilize a neoantigen nanovaccine constructed from the bacterial membranes of an engineered Lactococcus lactis strain (FOLactis). This platform, independently developed by our center, expresses KRAS antigenic peptides. The vaccine will be administered as adjuvant therapy to post-operative patients with colorectal or pancreatic cancer who carry KRAS mutations and are at high risk of recurrence. The study aims to assess the safety, immunogenicity, and preliminary efficacy of this neoantigen nanovaccine in a clinical setting.

Timeline

Start
2026-03-23
Primary completion
2029-01-01
Completion
2031-01-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Pidilizumab Monoclonal antibody 1.5 mg Subcutaneous
Subject Pidilizumab Monoclonal antibody 3 mg Subcutaneous