drugset / Trial / NCT07353645
KRAS Neoantigen Nanovaccine as Adjuvant Therapy for Colorectal Cancer/Pancreatic Cancer
Phase 1/2
Recruiting
49 enrolled
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pidilizumab | Monoclonal antibody | 1.5 mg | Subcutaneous |
| Subject | Pidilizumab | Monoclonal antibody | 3 mg | Subcutaneous |