NeoplasmsEarly Phase 1BMD-PLATNCT07657611
Inhaled mRNA Immunotherapy for Patients With Advanced Lung Cancer or Pulmonary Metastatic Solid Tumors
A Early Phase 1 study testing Inhaled mRNA in people with Neoplasms and Solid Tumors, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms, Solid Tumors, Neoplasm Metastasis
- What is being tested?
- Inhaled mRNA
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 10 Jun 2026to Dec 2029
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- Active autoimmune disease requiring systemic immunosuppressive therapy.
- Pregnant or breastfeeding women.
- Any condition that, in the investigator's opinion, would interfere with study compliance or safety.
About this study
Official title: A Platform Study of In Vivo Inhaled mRNA Technology for Multi-Target Immunotherapy Against Solid Tumors
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.
Read the detailed description
This is an open-label, single-arm, phase I master platform clinical trial designed to assess the safety, tolerability, pharmacokinetic profiles and preliminary anti-tumor activity of multiple investigational inhaled in-vivo mRNA multi-target immunotherapy candidates in adult subjects diagnosed with unresectable locally advanced or metastatic solid tumors.
The study adopts the standard 3+3 dose-escalation design for each individual mRNA product. Eligible participants will receive study drug via pulmonary inhalation on predefined treatment cycles with gradual dose increment across sequential cohorts to identify the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D). After completion of dose escalation, an optional expansion cohort at RP2D will be enrolled to further characterize safety and preliminary anti-tumor efficacy.
All enrolled patients will undergo regular safety monitoring including adverse event recording, laboratory examinations, pulmonary function test and radiological tumor assessment per protocol schedule. The primary study endpoints focus on treatment-related adverse events and MTD determination; secondary endpoints include objective response rate, disease control rate, duration of response as well as pharmacokinetic parameters of inhaled mRNA agents. Subjects will continue assigned study treatment until confirmed disease progression, unacceptable toxicity, withdrawal of consent or study closure.
- Conditions
- Neoplasms, Solid Tumors, Neoplasm Metastasis
- Being tested
- Inhaled mRNA
- Medical subject headings
- Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhaled mRNABiological
Inhaled mRNA dry powder formulation, administered via a low-resistance dry powder inhaler.
| Study group | Role | What they receive |
|---|---|---|
| Inhaled mRNA Immunotherapy | Experimental | All enrolled subjects will receive inhaled mRNA immunotherapy via Breezhaler dry powder inhaler.
* Intervention 1: BMD007-T1 mRNA dry powder, 300 mcg per capsule, administered on Days 1 and 7, then weekly thereafter.
* Intervention 2: BMD014-T5 mRNA dry powder, 300 mcg per capsule, administered on Days 1 and 7, then weekly thereafter.
* Intervention 3: BMD013-T3 mRNA dry powder, 300 mcg per capsule, administered on Days 1 and 7, then weekly thereafter.
Dose escalation will follow a standard 3+3 design. Treatment duration will not exceed 52 weeks. Receives: Biological: Inhaled mRNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From the first dose of study treatment up to 30 days after the last dose.
Secondary outcomes (1)
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.
Measured: Up to 28 days after the last dose in each dose cohort.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study start10 Jun 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm open-label phase I trial with standard 3+3 dose-escalation design for multiple inhaled mRNA immunotherapy agents.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07657611
- Sponsor's protocol ID
- NCC6293
- Other IDs
- NCC6293
- Acronym
- BMD-PLAT
- Status last verified
- Jun 2026
- First submitted
- 14 Jun 2026
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Platform Study of In Vivo Inhaled mRNA Technology for Multi-Target Immunotherapy Against Solid Tumors
- ClinicalTrials.gov ID
- NCT07657611
- Acronym / sponsor ID
- BMD-PLAT / NCC6293
- Conditions
- Neoplasms, Solid Tumors, Neoplasm Metastasis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 10 Jun 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 18 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is an open-label, single-arm, phase I master platform clinical trial designed to assess the safety, tolerability, pharmacokinetic profiles and preliminary anti-tumor activity of multiple investigational inhaled in-vivo mRNA multi-target immunotherapy candidates in adult subjects diagnosed with unresectable locally advanced or metastatic solid tumors.
The study adopts the standard 3+3 dose-escalation design for each individual mRNA product. Eligible participants will receive study drug via pulmonary inhalation on predefined treatment cycles with gradual dose increment across sequential cohorts to identify the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D). After completion of dose escalation, an optional expansion cohort at RP2D will be enrolled to further characterize safety and preliminary anti-tumor efficacy.
All enrolled patients will undergo regular safety monitoring including adverse event recording, laboratory examinations, pulmonary function test and radiological tumor assessment per protocol schedule. The primary study endpoints focus on treatment-related adverse events and MTD determination; secondary endpoints include objective response rate, disease control rate, duration of response as well as pharmacokinetic parameters of inhaled mRNA agents. Subjects will continue assigned study treatment until confirmed disease progression, unacceptable toxicity, withdrawal of consent or study closure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm open-label phase I trial with standard 3+3 dose-escalation design for multiple inhaled mRNA immunotherapy agents.
| Arm | Type | Receives |
|---|---|---|
| Inhaled mRNA Immunotherapy | Experimental | Biological: Inhaled mRNAAll enrolled subjects will receive inhaled mRNA immunotherapy via Breezhaler dry powder inhaler. * Intervention 1: BMD007-T1 mRNA dry powder, 300 mcg per capsule, administered on Days 1 and 7, then weekly thereafter. * Intervention 2: BMD014-T5 mRNA dry powder, 300 mcg per capsule, administered on Days 1 and 7, then weekly thereafter. * Intervention 3: BMD013-T3 mRNA dry powder, 300 mcg per capsule, administered on Days 1 and 7, then weekly thereafter. Dose escalation will follow a standard 3+3 design. Treatment duration will not exceed 52 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
- Active autoimmune disease requiring systemic immunosuppressive therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inhaled mRNAInhaled mRNA dry powder formulation, administered via a low-resistance dry powder inhaler. | Biological | Inhaled mRNA Immunotherapy |
Primary outcome
Safety and Tolerability
Time frame: From the first dose of study treatment up to 30 days after the last dose.
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).
1 secondary outcome
Maximum Tolerated Dose (MTD) / Recommended Phase 2 Dose (RP2D)
Time frame: Up to 28 days after the last dose in each dose cohort.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Inhaled mRNA in people with Neoplasms and Solid Tumors, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability (time frame: From the first dose of study treatment up to 30 days after the last dose.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.