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

Recruiting now · Phase 1

Conditions studied: Cancer

In brief

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).

Key facts

Study ID: NCT07560943
Run by: West China Hospital
People needed: 9
Starts: 2026-04-28
Expected to finish: 2027-12-28
Last updated by the study team: 2026-05-11

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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:
Hemoglobin ≥90 g/L (no blood transfusion within 14 days)
Absolute neutrophil count >1.5×10⁹/L
Platelet count ≥80×10⁹/L
Total bilirubin ≤1.5×ULN
ALT or AST ≤2.5×ULN (≤5×ULN if liver metastases present)
Creatinine clearance ≥60 mL/min (Cockcroft-Gault formula)
Left ventricular ejection fraction (LVEF) ≥50%
Signed written informed consent and willingness to comply with scheduled visits, treatment plans, laboratory tests, and other study requirements

You may not qualify if…

Participation in another clinical drug trial within 4 weeks
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
History of drug abuse or known medical, psychological, or social conditions (e.g., alcoholism, drug addiction)
Known allergy, hypersensitivity, or intolerance to PAN-NeoVax or any excipient; history of severe allergic reactions to any drug, food, or vaccine (including anaphylactic shock, allergic laryngeal edema, allergic dyspnea, allergic purpura, thrombocytopenic purpura, Arthus reaction)
Female subjects with pregnancy plans or male subjects whose partners have pregnancy plans from screening through 12 months after the last dose
Any serious concomitant disease that, in the investigator's judgment, would jeopardize patient safety or ability to complete the study

Where it is running

The West China Hospital — Chengdu, Sichuan, China (enrolling)
West China Hospital — Chengdu, Sichuan, China

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.