NCT06019702

Clinical Study of Personalized mRNA Vaccine Encoding Neoantigen Alone in Subjects With Advanced Digestive System Neoplasms

A Clinical Study to Assess the Safety, Feasibility, and Efficacy of Personalized mRNA Vaccine Encoding Neoantigen Alone in Subjects With Advanced Digestive System Neoplasms

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Sir Run Run Shaw Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the safety, feasibility, and efficacy of personalized mRNA vaccine iNeo-Vac-R01 alone in subjects with advanced digestive system neoplasms.

Detailed description

This is a multi-part single-center, open-label, single-arm clinical study of personalized mRNA vaccine iNeo-Vac-R01 monotherapy in subjects with advanced digestive system neoplasms. The study will include a dose escalation phase and dose expansion phase. The traditional 3+3 design will be used in dose escalation.

Conditions

• Digestive System Neoplasms

Interventions

Type	Name	Description
BIOLOGICAL	iNeo-Vac-R01	Personalized mRNA vaccine encoding neoantigen, IH injection

Timeline

• Start date: 2023-09-08
• Primary completion: 2027-08-31
• Completion: 2027-12-31
• First posted: 2023-08-31
• Last updated: 2023-09-11

Locations

1 site across 1 country: China