Inhaled mRNA therapy takes on solid tumors in first human trial
NCT ID NCT07657611
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase study tests an inhaled mRNA immunotherapy for adults with advanced lung cancer or solid tumors that have spread to the lungs. The treatment is given as a dry powder through an inhaler. The main goal is to check safety and find the best dose, with 60 participants expected.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Inhaled mRNA dry powder formulation
- What this could lead to
- If it works, this could point toward a new way to treat advanced solid tumors using inhaled mRNA immunotherapy, potentially offering a non-invasive option.
- What could go wrong
- This is an early-phase trial with only 60 participants, focused on safety and dosing. It is too soon to know if it will be effective, and there may be unknown side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Male or female patients aged ≥ 18 years. 2. 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. 3. Presence of at least one measurable lesion according to RECIST v1.1. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 5. Adequate organ function, including hematologic, hepatic, and renal function. 6. Ability to understand and sign the informed consent form. 7. Expected survival of at least 12 weeks. Exclusion Criteria: 1. History of severe hypersensitivity to mRNA-based therapies or components of the study drug. 2. Uncontrolled active infection or severe underlying respiratory disease (e.g., severe COPD, asthma requiring high-dose steroids). 3. Prior allogeneic stem cell or solid organ transplantation. 4. Current use of other investigational agents within 4 weeks before the first dose of study treatment. 5. Active autoimmune disease requiring systemic immunosuppressive therapy. 6. Pregnant or breastfeeding women. 7. Any condition that, in the investigator's opinion, would interfere with study compliance or safety.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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