Actively Recruiting

Phase 1
Age: 18Years - 70Years
All Genders
NCT07560943

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

Led by West China Hospital · Updated on 2026-05-11

9

Participants Needed

2

Research Sites

87 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female patients aged 6 and 70 years
  • Histopathologically confirmed advanced recurrent or metastatic malignant solid tumors that failed second-line therapy with no standard treatment options
  • Priority enrollment for advanced head and neck squamous cell carcinoma and malignant melanoma patients
  • ECOG Performance Status score of 0 or 1
  • Estimated life expectancy of at least 3 months
  • At least 28 days since prior chemotherapy, radiotherapy, or surgery
  • At least 6 weeks since prior use of nitrosoureas or mitomycin C
  • Adequate organ function within 14 days prior to enrollment:
    • Hemoglobin 90 g/L (no blood transfusion within 14 days)
    • Absolute neutrophil count greater than 1.5�d710�b9/L
    • Platelet count 80�d710�b9/L
    • Total bilirubin 1.5 times upper limit of normal
    • ALT or AST 2.5 times upper limit of normal (up to 5 times if liver metastases present)
    • Creatinine clearance at least 60 mL/min (Cockcroft-Gault formula)
    • Left ventricular ejection fraction at least 50%
  • Signed informed consent and willingness to comply with study requirements
Not Eligible

You will not qualify if you...

  • Participation in another clinical drug trial within 4 weeks
  • Tumor located adjacent to major blood vessels or trachea
  • Poorly controlled cardiac conditions such as NYHA class greater than 2 heart failure, unstable angina, recent myocardial infarction within 1 year, or serious arrhythmias needing treatment
  • Pregnant or breastfeeding women
  • Active pulmonary tuberculosis, bacterial or fungal infection (Grade 2 or higher per NCI-CTCAE v5.0), HIV infection, or active hepatitis B or C infection
  • History of psychotropic substance abuse or mental disorders
  • Active or history of autoimmune disease (exceptions: vitiligo; childhood asthma in remission without adult treatment)
  • Current immunosuppressive therapy
  • History of drug abuse or serious medical, psychological, or social conditions
  • Known allergy or intolerance to PAN-NeoVax or any excipient, or history of severe allergic reactions to drugs, food, or vaccines
  • Female patients planning pregnancy or males with partners planning pregnancy during study and 12 months after last dose
  • Any serious concomitant disease that may endanger patient safety or ability to complete the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

West China Hospital

Chengdu, Sichuan, China, 610000

Not Yet Recruiting

2

The West China Hospital

Chengdu, Sichuan, China, 646000

Actively Recruiting

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Research Team

X

Xingchen Peng

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

3

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