Safety and Tolerability of AI-Designed Pan-Cancer Neoantigen mRNA Vaccine (PAN-NeoVax) in Advanced Solid Tumors
Eligible age
18–70 yrs
Accepts
All genders
Locations
0 states
Healthy volunteers
No
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About this study
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).
Sponsor: West China Hospital
You may qualify if…
- ✓ 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)
You may not qualify if…
- ✕ 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
Source: ClinicalTrials.gov · NCT07560943 · last updated 2026-05-11