Safety and Tolerability of AI-Designed Pan-Cancer Neoantigen mRNA Vaccine (PAN-NeoVax) in Advance… (NCT07560943) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Safety and Tolerability of AI-Designed Pan-Cancer Neoantigen mRNA Vaccine (PAN-NeoVax) in Advanced Solid Tumors
China9 participantsStarted 2026-04-28
Plain-language summary
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).
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Male or female patients aged ≥18 and ≤70 years
✓. 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)
✓. ECOG Performance Status score: 0-1
✓. Estimated life expectancy ≥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:
✓. Signed written informed consent and willingness to comply with scheduled visits, treatment plans, laboratory tests, and other study requirements
Exclusion criteria
✕. Participation in another clinical drug trial within 4 weeks
What they're measuring
1
Number of Participants with DLT
Timeframe: From the first dose to 3 weeks post-dose.
✕. Tumor located adjacent to major blood vessels or trachea
✕. 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
✕. Pregnant or breastfeeding women
✕. Active pulmonary tuberculosis, bacterial or fungal infection (≥Grade 2 per NCI-CTCAE v5.0); HIV infection, active HBV or HCV infection
✕. History of psychotropic substance abuse that cannot be discontinued, or mental disorders
✕. 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)
✕. Currently receiving immunosuppressive therapy