AI-designed pan-cancer neoantigen mRNA vaccine (PAN-NeoVax) for adults with advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 1, open-label, single-arm, single-center dose-escalation trial gives PAN-NeoVax intratumorally to adults with advanced or metastatic solid tumors after second-line therapy failure. The trial uses a classical 3+3 design with three dose levels (25 µg, 50 µg, 100 µg) and each participant receives five doses (four weekly doses followed by a booster one month after the fourth dose). PAN-NeoVax is an AI-designed neoantigen mRNA formulated in lipid nanoparticles to stimulate tumor-directed immune responses. Primary endpoints focus on safety and tolerability with collection of preliminary anti-tumor activity signals.

Why it matters

Who can join: the full rules

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

Where it's running

• The West China Hospital
  Chengdu, Sichuan, China Recruiting
• West China Hospital
  Chengdu, Sichuan, China Not yet recruiting

Study contacts

• Study coordinator: Xingchen Peng
• Email: pxx2014@163.com
• Phone: 18980606753

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.