Actively Recruiting
Inhaled mRNA Tumor-associated Antigen Dry Powder Vaccine in Advanced Lung Cancer and Lung Metastasis of Solid Tumors.
Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2026-01-13
83
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
BMD006 is an inhaled mRNA tumor-associated antigen dry powder vaccine targeting lung cancer and solid tumors with lung metastasis, classified as an off-the-shelf anti-tumor product. The product contains two clinically validated TAA antigen combinations: for patients with solid tumors that have lung metastasis, the mRNA vaccine consists of four mRNA sequences encoding melanoma-associated tumor antigens ; for patients with primary lung cancer, the mRNA vaccine consists of six mRNA sequences encoding tumor-associated antigens of primary lung cancer . This study is a single-center, open-label, dose-escalation trial designed to evaluate the safety, tolerability, preliminary efficacy, PK, and PD of BMD006 in patients with advanced lung cancer or advanced solid tumors with lung metastasis who have failed standard treatments or have no standard treatment options. Additionally, the study will further explore the effect of BMD006 in combination with PD-1 or Ivonescimab Injection treatment.
CONDITIONS
Official Title
Inhaled mRNA Tumor-associated Antigen Dry Powder Vaccine in Advanced Lung Cancer and Lung Metastasis of Solid Tumors.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and follow the study requirements and sign informed consent
- At least 18 years old at consent, any gender
- Confirmed advanced lung cancer (driver gene negative) or advanced solid tumors with lung metastasis
- Failed prior standard treatments or have no standard treatment options
- Agree to provide fresh or archived tumor tissue samples within the past 3 years
- Have at least one measurable tumor lesion
- ECOG performance status of 0 or 1
- Adequate organ function as defined by blood counts, liver, kidney, heart, and lung function tests
- Expected life expectancy of at least 12 weeks
- Use highly effective contraception during the study and for 6 months after last dose if of childbearing potential
You will not qualify if you...
- Other types of malignant tumors or multiple primary cancers (except fully removed basal cell or squamous skin cancers, or carcinoma in situ)
- Symptomatic central nervous system metastasis; stable or asymptomatic brain metastasis allowed with conditions
- Chronic obstructive pulmonary disease, asthma, or allergies to pollen or dust
- Active or latent tuberculosis without completed treatment
- History of lung diseases like interstitial lung disease or active pneumonia needing immunosuppressive treatment
- Active autoimmune diseases requiring treatment
- Serious bleeding or blood clotting disorders
- Cardiovascular diseases including recent heart attack, heart failure, unstable angina, or significant arrhythmias
- Uncontrolled fluid buildup like pleural or pericardial effusion
- Severe infections requiring hospitalization or intravenous antibiotics recently
- Severe allergic reactions or allergies to study drugs
- Other serious medical conditions posing risks during treatment
- Unresolved toxicities from prior cancer treatments above grade 1
- Positive tests for hepatitis B or C or HIV
- Major surgery within 4 weeks before treatment or unresolved wounds
- Prior similar treatments
- Recent anti-tumor treatments within 4 weeks or 5 half-lives
- Use of systemic immunosuppressants within 3 months
- Use of live vaccines within 3 months before or during study
- Pregnant or breastfeeding women
- Participation in another clinical drug trial within 3 months or 5 half-lives
- Any other conditions making participation unsafe as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, China
Actively Recruiting
Research Team
S
Shuhang Wang, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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