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RECRUITING
NCT06577532
EARLY_PHASE1

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

Sponsor: Ruijin Hospital

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

56

Start Date

2024-09-24

Completion Date

2027-08

Last Updated

2025-05-21

Healthy Volunteers

No

Interventions

DRUG

ABO2102

mRNA encoding mutant KRAS neoantigens, administrated intramuscularly

DRUG

Toripalimab

Anti-PD-1 antibody, administered intravenously

Locations (1)

Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, China