[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100641305":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":20,"locations":20,"responsibleParty":21,"collaborators":20,"id":23,"slug":20,"hasResults":24,"nctId":25,"briefTitle":26,"officialTitle":27,"acronym":28,"eligibilityCriteria":29,"healthyVolunteers":24,"sex":30,"minAge":31,"maxAge":20,"enrollmentInfo":32,"targetDuration":20,"studyType":35,"phases":36,"briefSummary":38,"conditions":39,"keywords":20,"overallStatus":43,"whyStopped":20,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":20},{"fullName":5,"class":6},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Inhaled mRNA Immunotherapy","EXPERIMENTAL","All enrolled subjects will receive inhaled mRNA immunotherapy via Breezhaler dry powder inhaler.\n\n* Intervention 1: BMD007-T1 mRNA dry powder, 300 mcg per capsule, administered on Days 1 and 7, then weekly thereafter.\n* Intervention 2: BMD014-T5 mRNA dry powder, 300 mcg per capsule, administered on Days 1 and 7, then weekly thereafter.\n* Intervention 3: BMD013-T3 mRNA dry powder, 300 mcg per capsule, administered on Days 1 and 7, then weekly thereafter.\n\nDose escalation will follow a standard 3+3 design. Treatment duration will not exceed 52 weeks.",[13],"Biological: Inhaled mRNA",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","Inhaled mRNA","Inhaled mRNA dry powder formulation, administered via a low-resistance dry powder inhaler.",[9],null,{"type":22,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100641305",false,"NCT07657611","Inhaled mRNA Immunotherapy for Patients With Advanced Lung Cancer or Pulmonary Metastatic Solid Tumors","A Platform Study of In Vivo Inhaled mRNA Technology for Multi-Target Immunotherapy Against Solid Tumors","BMD-PLAT","Inclusion Criteria:\n\n1. Male or female patients aged ≥ 18 years.\n2. 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.\n3. Presence of at least one measurable lesion according to RECIST v1.1.\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n5. Adequate organ function, including hematologic, hepatic, and renal function.\n6. Ability to understand and sign the informed consent form.\n7. Expected survival of at least 12 weeks.\n\nExclusion Criteria:\n\n1. History of severe hypersensitivity to mRNA-based therapies or components of the study drug.\n2. Uncontrolled active infection or severe underlying respiratory disease (e.g., severe COPD, asthma requiring high-dose steroids).\n3. Prior allogeneic stem cell or solid organ transplantation.\n4. Current use of other investigational agents within 4 weeks before the first dose of study treatment.\n5. Active autoimmune disease requiring systemic immunosuppressive therapy.\n6. Pregnant or breastfeeding women.\n7. Any condition that, in the investigator's opinion, would interfere with study compliance or safety.","ALL","18 Years",{"count":33,"type":34},60,"ESTIMATED","INTERVENTIONAL",[37],"EARLY_PHASE1","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.",[40,41,42],"Neoplasms","Solid Tumors","Neoplasm Metastasis","NOT_YET_RECRUITING","2026-06-14",{"date":46,"type":47},"2026-06-18","ACTUAL",{"date":49,"type":34},"2026-06-10",{"date":51,"type":34},"2029-12",{"name":5,"class":6}]