NCT07363369

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

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

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: West China Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Malignant Solid Tumors

Interventions

Type	Name	Description
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

Timeline

• Start date: 2026-01-25
• Primary completion: 2026-12-31
• Completion: 2027-12-31
• First posted: 2026-01-23
• Last updated: 2026-01-23