mRNA Vaccine for Advanced Lung Cancer and Pulmonary Metastases of Solid Tumors

BMD006 is an off-the-shelf antitumor mRNA vaccine targeting lung cancer and lung metastatic solid tumors. This is a single-center, open-label, dose-escalation clinical trial. The study aims to evaluate the safety, tolerability, preliminary efficacy, pharmacokinetic (PK), and pharmacodynamic (PD) profiles of BMD006 in patients with advanced lung cancer or advanced solid tumors with lung metastasis who have progressed on or are ineligible for standard therapeutic options. This trial also further explores the clinical efficacy of BMD006 in combination with Immuno-Oncology (IO) therapy.

Inclusion Criteria: * Able to understand and comply with the requirements of the study protocol, voluntarily participate in the trial, and sign a written informed consent form (ICF). * Must be at least 18 (inclusive) at the time of signing the ICF, and both male and female participants are eligible. * Histologically or cytologically confirmed as advanced lung cancer (driver gene negative) or advanced solid tumors with lung metastasis, and having failed prior standard treatments or having no standard treatment options. * Agree to provide fresh tumor tissue samples or archived tumor tissue samples within the past three years. * Presence of at least one measurable lesion as defined by RECIST V1.1 * Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-1 * Organ function must be adequate at screening (no need for blood transfusion, hematopoietic growth factors, human albumin, or medications for correction within 14 days prior to first treatment), specifically defined as: a) Hematology: Absolute neutrophil count ≥1.5×10\^9/L; platelet count ≥90×10\^9/L; hemoglobin ≥90 g/L (9 g/dL). b) Liver Function: Serum total bilirubin (TBIL) ≤1.5× upper limit of normal (ULN); for patients with liver metastasis or a history/suspected history of Gilbert's syndrome (persistent or recurrent hyperbilirubinemia, primarily unconjugated bilirubin, with no evidence of hemolysis or liver pathology), TBIL ≤3×ULN; for patients without liver metastasis, alanine aminotransferase (ALT) and aspartate aminotransferase (AST); for patients with liver metastasis, ALT or AST ≤5×ULN. c) Renal Function: Creatinine (Cr) ≤1.5×ULN or creatinine clearance (CLcr) ≥60 mL/min (calculated using the Cockcroft-Gault formula, see Attachment 3); urine dipstick test result showing urinary protein \