Safety and Tolerability of AI-Designed Pan-Cancer Neoantigen mRNA Vaccine (PAN-NeoVax) in Advanced Solid Tumors

May 5, 2026 updated by: Xingchen Peng, West China Hospital

A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of an Artificial Intelligence-Designed Tumor mRNA Vaccine in Patients With Advanced or Metastatic Solid Tumors

This is a phase I, open-label, single-arm, single-center, dose-escalation study to evaluate the safety, tolerability, and preliminary anti-tumor efficacy of PAN-NeoVax, an artificial intelligence (AI)-designed pan-cancer neoantigen mRNA vaccine delivered via lipid nanoparticles (LNP), administered by intratumoral injection in patients with advanced or metastatic solid tumors who have failed second-line therapy. The study employs a classical "3+3" dose-escalation design with three dose levels (25 μg, 50 μg, and 100 μg mRNA). Each subject will receive 5 doses of basic immunization (first 4 doses at weekly intervals, fifth dose at 1 month after the fourth dose).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

9

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610000
        • Not yet recruiting
        • West China Hospital
        • Contact:
      • Chengdu, Sichuan, China, 646000
        • Recruiting
        • The West China Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Male or female patients aged ≥18 and ≤70 years
  2. Histopathologically confirmed advanced recurrent/metastatic malignant solid tumors that have failed second-line therapy with no standard treatment options available (priority enrollment of advanced head and neck squamous cell carcinoma and malignant melanoma patients)
  3. ECOG Performance Status score: 0-1
  4. Estimated life expectancy ≥3 months
  5. At least 28 days since prior chemotherapy, radiotherapy, or surgery
  6. At least 6 weeks since prior use of nitrosoureas or mitomycin C

  7. Adequate organ function within 14 days prior to enrollment:

    • Hemoglobin ≥90 g/L (no blood transfusion within 14 days)
    • Absolute neutrophil count >1.5×10⁹/L
    • Platelet count ≥80×10⁹/L
    • Total bilirubin ≤1.5×ULN
    • ALT or AST ≤2.5×ULN (≤5×ULN if liver metastases present)
    • Creatinine clearance ≥60 mL/min (Cockcroft-Gault formula)
    • Left ventricular ejection fraction (LVEF) ≥50%
  8. Signed written informed consent and willingness to comply with scheduled visits, treatment plans, laboratory tests, and other study requirements

Exclusion Criteria:

  1. Participation in another clinical drug trial within 4 weeks
  2. Tumor located adjacent to major blood vessels or trachea
  3. Poorly controlled cardiac conditions: NYHA class >2 heart failure, unstable angina, myocardial infarction within 1 year, or clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention
  4. Pregnant or breastfeeding women
  5. Active pulmonary tuberculosis, bacterial or fungal infection (≥Grade 2 per NCI-CTCAE v5.0); HIV infection, active HBV or HCV infection
  6. History of psychotropic substance abuse that cannot be discontinued, or mental disorders
  7. Active autoimmune disease or history of autoimmune disease (exceptions: vitiligo; childhood asthma in complete remission requiring no adult intervention; asthma requiring bronchodilator intervention is excluded)
  8. Currently receiving immunosuppressive therapy
  9. History of drug abuse or known medical, psychological, or social conditions (e.g., alcoholism, drug addiction)
  10. Known allergy, hypersensitivity, or intolerance to PAN-NeoVax or any excipient; history of severe allergic reactions to any drug, food, or vaccine (including anaphylactic shock, allergic laryngeal edema, allergic dyspnea, allergic purpura, thrombocytopenic purpura, Arthus reaction)
  11. Female subjects with pregnancy plans or male subjects whose partners have pregnancy plans from screening through 12 months after the last dose
  12. Any serious concomitant disease that, in the investigator's judgment, would jeopardize patient safety or ability to complete the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PAN-NeoVax Dose Level 1 (25 μg)
Biological: PAN-NeoVax (25 μg)
25 μg PAN-NeoVax administered by intratumoral injection; 5 doses of basic immunization (first 4 doses at weekly intervals, fifth dose at 1 month after the fourth dose).
Experimental: PAN-NeoVax Dose Level 2 (50 μg)
Biological: PAN-NeoVax (50 μg)
50 μg PAN-NeoVax administered by intratumoral injection; 5 doses of basic immunization (first 4 doses at weekly intervals, fifth dose at 1 month after the fourth dose).
Experimental: PAN-NeoVax Dose Level 3 (100 μg)
Biological: PAN-NeoVax (100 μg)
100 μg PAN-NeoVax administered by intratumoral injection; 5 doses of basic immunization (first 4 doses at weekly intervals, fifth dose at 1 month after the fourth dose).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants with DLT
Time Frame: From the first dose to 3 weeks post-dose.
From the first dose to 3 weeks post-dose.

Secondary Outcome Measures

Outcome Measure
Time Frame
Objective Response Rate
Time Frame: From the time when the patients were enrolled in the study until one month after the last dose was injected.The time window was typically 2 months.
From the time when the patients were enrolled in the study until one month after the last dose was injected.The time window was typically 2 months.
Disease Control Rate
Time Frame: From the time when the patients were enrolled in the study until one month after the last dose was injected.The time window was typically 2 months.
From the time when the patients were enrolled in the study until one month after the last dose was injected.The time window was typically 2 months.
Time to First Response
Time Frame: From the time when the patients were enrolled in the study until one month after the last dose was injected.The time window was typically 2 months.
From the time when the patients were enrolled in the study until one month after the last dose was injected.The time window was typically 2 months.
Duration of Response
Time Frame: From the time when the patients were enrolled in the study until one month after the last dose was injected.The time window was typically 2 months.
From the time when the patients were enrolled in the study until one month after the last dose was injected.The time window was typically 2 months.
Progression - Free Survival(PFS)
Time Frame: From the time when the patients were enrolled in the study until three months after the last dose was injected. The time window was typically 6 months.
From the time when the patients were enrolled in the study until three months after the last dose was injected. The time window was typically 6 months.
Overall Survival(OS)
Time Frame: From the time when the patients were enrolled in the study until six months after the last dose was injected. The time window was typically 8 months.
From the time when the patients were enrolled in the study until six months after the last dose was injected. The time window was typically 8 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

West China Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 28, 2026

Primary Completion (Estimated)

April 28, 2027

Study Completion (Estimated)

December 28, 2027

Study Registration Dates

First Submitted

April 24, 2026

First Submitted That Met QC Criteria

April 24, 2026

First Posted (Actual)

May 1, 2026

Study Record Updates

Last Update Posted (Actual)

May 11, 2026

Last Update Submitted That Met QC Criteria

May 5, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2026(826)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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