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.
Male or female patients aged ≥ 18 years.
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.
Presence of at least one measurable lesion according to RECIST v1.1.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
History of severe hypersensitivity to mRNA-based therapies or components of the study drug.
Uncontrolled active infection or severe underlying respiratory disease (e.g., severe COPD, asthma requiring high-dose steroids).
Prior allogeneic stem cell or solid organ transplantation.
Current use of other investigational agents within 4 weeks before the first dose of study treatment.
Single group
Inhaled mRNA
Biological/VaccineInhaled mRNA dry powder formulation, administered via a low-resistance dry powder inhaler.
Safety and Tolerability
The primary endpoint is to assess the safety and tolerability of inhaled mRNA immunotherapy, including the incidence and severity of adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs).
Maximum Tolerated Dose (MTD) / Recommended Phase 2 Dose (RP2D)
To determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of inhaled mRNA immunotherapy using a standard 3+3 dose-escalation design.
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