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NOT YET RECRUITING
NCT07363369
PHASE1

Exploratory Clinical Study of FAP mRNA Vaccine in Patients With Advanced Malignant Solid Tumors

Sponsor: West China Hospital

View on ClinicalTrials.gov

Summary

Cancer-associated fibroblasts (CAFs), as core regulators within the tumor microenvironment, significantly impede the intratumoral penetration of therapeutic agents and suppress the effective infiltration and activation of immune cells by constructing elaborate physical and functional barriers. Fibroblast activation protein (FAP) is a highly specific therapeutic target for CAFs, owing to its nearly tumor-restricted expression profile. Therefore, developing therapeutic strategies that specifically target FAP to eliminate CAFs and subsequently remodel the tumor microenvironment may effectively disrupt the multi-dimensional defense system established by CAFs, thereby significantly enhancing the delivery efficiency of anti-tumor agents and improving responsiveness to immunotherapy. This Phase I clinical trial aims to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity of FAP mRNA Vaccine combined with immune checkpoint inhibitors in patients with advanced malignant solid tumors.

Official title: An Exploratory Basket Study on The Application of Therapeutic mRNA Vaccine Targeting FAP in Advanced Malignant Solid Tumors

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2026-01-25

Completion Date

2027-12-31

Last Updated

2026-01-23

Healthy Volunteers

No

Interventions

BIOLOGICAL

FAP mRNA vaccine (dose 1) + immune checkpoint inhibitors

FAP mRNA vaccine (dose 1) in combination with immune checkpoint inhibitors treatment

BIOLOGICAL

FAP mRNA vaccine (dose 2) + immune checkpoint inhibitors

FAP mRNA vaccine (dose 2) in combination with immune checkpoint inhibitors treatment

BIOLOGICAL

FAP mRNA vaccine (dose 3) + immune checkpoint inhibitors

FAP mRNA vaccine (dose 3) in combination with immune checkpoint inhibitors treatment

BIOLOGICAL

FAP mRNA vaccine (dose 4) + immune checkpoint inhibitors

FAP mRNA vaccine (dose 4) in combination with immune checkpoint inhibitors treatment