NCT06577532

Study of KRAS Neoantigen mRNA Vaccine (ABO2102) in Patients With KRAS -Mutated Solid Tumors

A Clinical Study to Investigate Safety, Tolerability, Immunogenicity, and Preliminary Efficacy of mRNA Nanoparticles Encoding KRAS Neoantigens (ABO2102) in Participants With KRAS-mutated Advanced Pancreatic Cancer And Other Solid Tumors

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety, immunogenicity, pharmacodynamics, as well as preliminary efficacy of KRAS neoantigen mRNA vaccine (ABO2102) alone and in combination with toripalimab (anti-PD-1 monoclonal antibody) among participants with KRAS-mutated advanced pancreatic cancer and other solid tumors. The trial includes dose escalation (Part I) and dose expansion(Part II) parts.

Conditions

• Pancreatic Neoplasms
• Other Solid Tumors

Interventions

Type	Name	Description
DRUG	ABO2102	mRNA encoding mutant KRAS neoantigens, administrated intramuscularly
DRUG	Toripalimab	Anti-PD-1 antibody, administered intravenously

Timeline

• Start date: 2024-09-24
• Primary completion: 2026-12-01
• Completion: 2027-08-01
• First posted: 2024-08-29
• Last updated: 2025-05-21

Locations

1 site across 1 country: China