NCT07657611Not yet recruitingEarly phase 1
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
Source: ClinicalTrials.gov · Last updated 18 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 14 Jun 2026
- Start date
- 10 Jun 2026
- Primary completion date
- Dec 2026
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Diseases
- Lung cancer
- NCT number
- NCT07657611
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 60
- From 10 Jun 2026 to the primary completion date, Dec 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior allogeneic stem cell or solid organ transplantation.
- Current use of other investigational agents within 4 weeks before the first dose of study treatment.
Other illness
- 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).
- Active autoimmune disease requiring systemic immunosuppressive therapy.
- Any condition that, in the investigator's opinion, would interfere with study compliance or safety.
Other
- Pregnant or breastfeeding women.
Who the study is looking for
- 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.
- Adequate organ function, including hematologic, hepatic, and renal function.
- Ability to understand and sign the informed consent form.
- Expected survival of at least 12 weeks.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.