RecruitingEarly Phase 1NCT06577532

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


Sponsor

Ruijin Hospital

Enrollment

56 participants

Start Date

Sep 24, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a personalized mRNA vaccine (ABO2102) that targets a specific mutation in the KRAS gene — a mutation found in many types of cancer — to see if it can help the immune system fight advanced solid tumors. **You may be eligible if...** - You are 18 years or older - You have an advanced or metastatic solid tumor (such as pancreatic cancer or lung cancer) with a KRAS mutation, confirmed by testing - Your cancer has progressed or you could not tolerate at least one prior line of treatment **You may NOT be eligible if...** - You do not have a KRAS mutation in your tumor - You have active autoimmune disease requiring systemic treatment - You have active brain metastases - You have serious heart, liver, or kidney problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGABO2102

mRNA encoding mutant KRAS neoantigens, administrated intramuscularly

DRUGToripalimab

Anti-PD-1 antibody, administered intravenously


Locations(1)

Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, China

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NCT06577532


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