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AzTrials

Advanced Malignant Solid TumorsPhase 1NCT07363369

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

A Phase 1 study testing FAP mRNA vaccine (dose 1) + immune checkpoint inhibitors, FAP mRNA vaccine (dose 2) + immune checkpoint inhibitors and FAP mRNA vaccine (dose 3) + immune checkpoint inhibitors in people with Advanced Malignant Solid Tumors, run by West China Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Malignant Solid Tumors
What is being tested?
FAP mRNA vaccine (dose 1) + immune checkpoint inhibitors, FAP mRNA vaccine (dose 2) + immune checkpoint inhibitors and FAP mRNA vaccine (dose 3) + immune checkpoint inhibitors
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
No sites listed yet
Study dates
25 Jan 2026to 31 Dec 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. Male or female patients: aged ≥ 18 years old;
  • 2. Patients with histopathologically confirmed advanced malignant solid tumors (such as patients with advanced lung cancer, advanced colorectal cancer, advanced pancreatic carcinoma, etc.);
  • 3. Patients refractory or intolerant to standard clinical treatment regimens;
  • 4. According to the RECIST 1.1 criteria, at least one measurable lesion is required;
  • 5. Eastern Cooperative Oncology Group (ECOG) performance status score: 0 - 1;
  • 6. Expected survival time ≥ 3 months;
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  • 7. Main organ functions are in good condition;
  • 8. Participants must have no plans for pregnancy during the treatment period and agree to use effective contraception voluntarily throughout the study period and for four months after discontinuation of treatment;
  • 9. Sign a written informed consent form;
  • 10. Ability to communicate effectively with the research team and willingness to comply fully with all protocol-specified requirements.

Who cannot join

  • 1. History of other malignancies, except for adequately treated and non-recurrent within 5 years prior to screening basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, cervical carcinoma in situ, or gastrointestinal mucosal carcinoma, which the investigator deems eligible for inclusion;
  • 2. Known central nervous system (CNS) metastases that are untreated or not effectively controlled by prior therapy;
  • 3. Patients with serious cavity effusion;
  • 4. Patient has comorbid conditions associated with elevated FAP expression beyond solid tumors, including pulmonary fibrosis, liver fibrosis, renal fibrosis, and rheumatoid arthritis, etc.;
  • 5. Patients with uncontrolled cardiac clinical symptoms or diseases, such as heart failure of NYHA class II or above, unstable angina pectoris, having had a myocardial infarction within six months, and having clinically significant supraventricular or ventricular arrhythmias that require treatment or intervention;
  • 6. A history of thrombotic events (arterial or venous) within 6 months prior to enrollment, such as deep vein thrombosis, and pulmonary embolism;
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  • 7. Any active autoimmune disease or history of autoimmune diseases, including but not limited to: neurologic diseases related to immunity, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barré syndrome, myasthenia gravis, systemic lupus erythematosus (SLE), connective tissue disorders, scleroderma, inflammatory bowel disease (including Crohn's disease and ulcerative colitis), autoimmune hepatitis, toxic epidermal necrolysis (TEN), or Stevens-Johnson syndrome (excluding type 1 diabetes mellitus controlled with stable-dose insulin);
  • 8. According to the investigator's judgment, there are concomitant uncontrolled diseases that may seriously endanger patient safety or affect the patient's completion of the study;
  • 9. A known history of interstitial pneumonia or highly suspected interstitial pneumonia; or patients with lung abnormalities that could interfere with the detection or management of suspected drug-related pulmonary toxicity during the study;
  • 10. Known allergy to the investigational drug (including any excipients). A history of severe allergic reactions to any drugs, foods, or vaccines, such as anaphylactic shock, allergic laryngeal edema, allergic dyspnea, allergic purpura, thrombocytopenic purpura, localized allergic necrotic reactions (Arthus reaction), etc.;
  • 11. The last anti-cancer treatment occurred less than 4 weeks before the first vaccination; patients with unresolved treatment-related adverse effects (except hair loss) from previous anti-cancer treatments;
  • 12. Patients who have previously received treatment with immune checkpoint inhibitors and experienced immune-related adverse events graded ≥3 according to the NCI CTCAE criteria;
  • 13. Systemic treatment with corticosteroids (>10 mg/day of prednisone or equivalent doses of other glucocorticoids) or other immunosuppressive agents within 14 days before the first dose of the vaccine. However, the following situations are allowed: In the absence of active autoimmune disease, inhaled or local use of corticosteroids or adrenal hormone replacement with <=10 mg/day prednisone is allowed;
  • 14. Received mRNA vaccines or lipid nanoparticles (LNP) or equivalent nanoparticle delivery drugs within 6 months prior to the first dose of the vaccine;
  • 15. Previously received live attenuated vaccine/inactivated vaccine within 6 months;
  • 16. Previous organ transplantation or allogeneic hematopoietic stem cell transplantation;
  • 17. Blood donation or significant blood loss (>450 mL) within 3 months prior to screening;
  • 18. Major surgery within 4 weeks prior to screening (small surgeries such as catheter placement, biopsy required by the protocol, etc., are not exclusion criteria), or the surgical or traumatic effects have not been resolved within 14 days before enrollment;
  • 19. A history of drug abuse or known medical, psychological, or social conditions, such as a history of alcoholism or drug abuse;
  • 20. Human immunodeficiency virus (HIV) positive, or positive for syphilis antibodies; patients with active HBV infection, or HCV infection;
  • 21. Patients with active tuberculosis (TB) or a history of active TB; or those requiring systemic treatment for severe acute or chronic infections
  • 22. Pregnant or breastfeeding women;
  • 23. Any other factors that the investigator believes may make the patient unsuitable for participation in the study.

About this study

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

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.

Being tested
FAP mRNA vaccine (dose 1) + immune checkpoint inhibitors, FAP mRNA vaccine (dose 2) + immune checkpoint inhibitors, FAP mRNA vaccine (dose 3) + immune checkpoint inhibitors, FAP mRNA vaccine (dose 4) + immune checkpoint inhibitors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FAP mRNA vaccine (dose 1) + immune checkpoint inhibitorsBiological

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

  • FAP mRNA vaccine (dose 2) + immune checkpoint inhibitorsBiological

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

  • FAP mRNA vaccine (dose 3) + immune checkpoint inhibitorsBiological

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

  • FAP mRNA vaccine (dose 4) + immune checkpoint inhibitorsBiological

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

Study groups in NCT07363369
Study groupRoleWhat they receive
FAP mRNA vaccine, Dose 1ExperimentalFAP mRNA vaccine
Receives: Biological: FAP mRNA vaccine (dose 1) + immune checkpoint inhibitors
FAP mRNA vaccine, Dose 2ExperimentalFAP mRNA vaccine
Receives: Biological: FAP mRNA vaccine (dose 2) + immune checkpoint inhibitors
FAP mRNA vaccine, Dose 3ExperimentalNot described
Receives: Biological: FAP mRNA vaccine (dose 3) + immune checkpoint inhibitors
FAP mRNA vaccine, Dose 4ExperimentalNot described
Receives: Biological: FAP mRNA vaccine (dose 4) + immune checkpoint inhibitors

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose-limiting toxicities (DLTs) and their incidence rates

    Measured: During one year after initial treatment

  2. Safety: Type, frequency, and severity of treatment-related adverse events as assessed by CTCAE V5.0

    Measured: During one year after initial treatment

Secondary outcomes (4)

  1. Objective response rate (ORR)

    Measured: During one year after initial treatment

  2. Disease control rate (DCR)

    Measured: During one year after initial treatment

  3. Progression-free survival (PFS)

    Measured: During one year after initial treatment

  4. Immunogenicity: Specific T cell levels targeting FAP antigen

    Measured: During one year after initial treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2026
  2. Study start25 Jan 2026 (estimated)
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07363369
Sponsor's protocol ID
2025-2148
Status last verified
Jan 2026
First submitted
12 Jan 2026
Last updated
23 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing FAP mRNA vaccine (dose 1) + immune checkpoint inhibitors, FAP mRNA vaccine (dose 2) + immune checkpoint inhibitors and FAP mRNA vaccine (dose 3) + immune checkpoint inhibitors in people with Advanced Malignant Solid Tumors, run by West China Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-limiting toxicities (DLTs) and their incidence rates (time frame: During one year after initial treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07363369.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.

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