Inhaled mRNA Immunotherapy for Patients With Advanced Lung Cancer or Pulmonary Metastatic Solid Tumors
NCT07657611 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2026-06-18
Summary
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.
Conditions
- Neoplasms
- Solid Tumors
- Neoplasm Metastasis
Interventions
- BIOLOGICAL
-
Inhaled mRNA
Inhaled mRNA dry powder formulation, administered via a low-resistance dry powder inhaler.
Sponsors & Collaborators
-
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-06-10
- Primary Completion
- 2026-12-31
- Completion
- 2029-12-31
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