Inhaled mRNA Immunotherapy for Patients With Advanced Lung Cancer or Pulmonary Metastatic Solid Tumors

This is an open-label phase I master platform study to evaluate the safety, tolerability and preliminary anti-tumor efficacy of multiple inhaled in-vivo mRNA immunotherapies in adult patients with advanced solid tumors. Subjects will receive inhalation mRNA formulations at ascending dose levels following a 3+3 dose-escalation design to determine maximum tolerated dose and recommended phase II dose.

Inclusion Criteria: 1. Male or female patients aged ≥ 18 years. 2. Confirmed diagnosis of advanced lung cancer (driver gene negative or targeted therapy failed) or pulmonary metastatic solid tumors, with no standard treatment options available or who have failed prior standard therapies. 3. Presence of at least one measurable lesion according to RECIST v1.1. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 5. Adequate organ function, including hematologic, hepatic, and renal function. 6. Ability to understand and sign the informed consent form. 7. Expected survival of at least 12 weeks. Exclusion Criteria: 1. History of severe hypersensitivity to mRNA-based therapies or components of the study drug. 2. Uncontrolled active infection or severe underlying respiratory disease (e.g., severe COPD, asthma requiring high-dose steroids). 3. Prior allogeneic stem cell or solid organ transplantation. 4. Current use of other investigational agents within 4 weeks before the first dose of study treatment. 5. Active autoimmune disease requiring systemic immunosuppressive therapy. 6. Pregnant or breastfeeding women. 7. Any condition that, in the investigator's opinion, would interfere with study compliance or safety.