Inhaled mRNA Immunotherapy for Patients With Advanced Lung Cancer or Pulmonary Metastatic Solid T… (NCT07657611) | Clinical Trial Compass
Not Yet RecruitingEarly Phase 1
Inhaled mRNA Immunotherapy for Patients With Advanced Lung Cancer or Pulmonary Metastatic Solid Tumors
60 participantsStarted 2026-06-10
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is in Early Phase 1 and hasn't started recruiting yet — given that it's at the very earliest stage of human testing, what does that mean for what's actually known about whether inhaled mRNA immunotherapy is safe or effective for my type of cancer?
2Since the trial is measuring safety and tolerability as its main goal rather than tumor response, how should I weigh participating in a study focused on finding a safe dose against other treatment options that already have more established safety and benefit data for my situation?
3My cancer involves either advanced lung cancer or metastatic solid tumors spreading to the lungs — can you help me understand whether my specific diagnosis and current disease stage would even make this trial worth discussing once it opens for enrollment?
4Because this treatment is delivered by inhalation directly into the lungs, are there any concerns about how that route of delivery might interact with my current lung health or any other conditions I have?
5Given that this trial isn't recruiting yet, what standard or approved treatment options should we be pursuing right now, and how would starting one of those affect my ability to consider this trial if I wanted to revisit it later?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety and Tolerability
Timeframe: From the first dose of study treatment up to 30 days after the last dose.
Trial details
NCT IDNCT07657611
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences