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

NCT07363369 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-01-23

No results posted yet for this study

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

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

Sponsors & Collaborators

  • West China Hospital

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-25
Primary Completion
2026-12-31
Completion
2027-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07363369 on ClinicalTrials.gov