Clinical Trial

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

Recruiting Phase 1
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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).
Protocol Amendment History 1 change
critical Recruitment opened 2026-05-12
Trial Details
NCT Number NCT07560943
Lead Sponsor West China Hospital
Conditions Cancer
Enrollment 9 participants
Start Date 2026-04-28
Primary Completion 2027-04-28 (estimated)
Study Completion 2027-12-28 (estimated)
Updated on ClinicalTrials.gov 2026-05-11