{"id":"nct:NCT07245901","kind":"trial","title":"Safety and Tolerability of a mRNA Vaccine Encoding Tumor-Specific Circular RNA Antigens in Combination With Anti-PD-1 Monoclonal Antibody in Patients With Advanced Solid Tumors","authors":["Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University"],"author_count":1,"year":2025,"published":"2025-11-24","venue":"ClinicalTrials.gov","cited_by":null,"doi":null,"arxiv_id":null,"nct_id":"NCT07245901","source_url":"https://clinicaltrials.gov/study/NCT07245901","archive_url":"https://space-kitty.com/papers/nct:NCT07245901","updated":"2025-11-24","pmid":null,"pmcid":null,"openalex_id":null,"pdf_url":null,"abstract":"This is an Investigator-initiated, Open-Label Clinical Study of a mRNA Vaccine Encoding Tumor-Specific Circular RNA Antigens in Combination with anti-PD-1 monoclonal antibody in Patients with Advanced Solid Tumors. Preclinical studies of this project have identified that circFAM53B, which is specifically overexpressed in tumor cells, possesses the ability to encode a cryptic peptide, FAM53B-219aa, representing a potential tumor vaccine target. In this study, the sequence encoding the cryptic antigen from circFAM53B will be linearized and formulated as an mRNA vaccine (circFAM53B mRNA injection). The vaccine will be administered via lipid nanoparticle (LNP) encapsulation, and its safety and efficacy will be evaluated in combination with anti-PD-1 monoclonal antibody therapy.","abstract_license":"ClinicalTrials.gov (U.S. National Library of Medicine), data processed 2026-10-29T09:00:05; modifications: selected fields only; whitespace normalized; brief summary truncated to 2,000 characters","license":"ClinicalTrials.gov terms (attribution, processing date, modifications noted)","is_open_access":true,"peer_reviewed":null,"categories":["Solid Tumor"],"details":{"acronym":null,"status":"NOT_YET_RECRUITING","phase":"PHASE1, PHASE2","study_type":"INTERVENTIONAL","enrollment":60,"sponsor":"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University","conditions":["Solid Tumor"],"interventions":["DRUG: circFAM53B mRNA vaccine","DRUG: toripalimab"],"start_date":"2025-12-05","start_date_type":"ESTIMATED","primary_completion_date":"2028-12-05","has_results":false,"data_source":"ClinicalTrials.gov","data_processed":"2026-10-29T09:00:05","modifications":"selected fields only; whitespace normalized; brief summary truncated to 2,000 characters"},"provenance":"clinicaltrials","attribution":"Source: ClinicalTrials.gov (U.S. National Library of Medicine), data processed 2026-10-29T09:00:05; modifications: selected fields only; whitespace normalized; brief summary truncated to 2,000 characters. Not a U.S. Government endorsement.","topics":[{"slug":"mrna-cancer-vaccines","name":"mRNA Therapeutics & Cancer Vaccines","domain_slug":"medicine"}],"cited_in_dossiers":[]}