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mRNA Vaccine for Advanced Lung Cancer and Pulmonary Metastases of Solid Tumors

RecruitingEARLY Phase 1Ages any - 99 YearsAllCancer Institute and Hospital, Chinese Academy of…
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In plain words

What the trial is, and whether it could suit you

BMD006 is an off-the-shelf antitumor mRNA vaccine targeting lung cancer and lung metastatic solid tumors. This is a single-center, open-label, dose-escalation clinical trial. The study aims to evaluate the safety, tolerability, preliminary efficacy, pharmacokinetic (PK), and pharmacodynamic (PD) profiles of BMD006 in patients with advanced lung cancer or advanced solid tumors with lung metastasis who have progressed on or are ineligible for standard therapeutic options. This trial also further explores the clinical efficacy of BMD006 in combination with Immuno-Oncology (IO) therapy.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * Able to understand and comply with the requirements of the study protocol, voluntarily participate in the trial, and sign a written informed consent form (ICF). * Must be at least 18 (inclusive) at the time of signing the ICF, and both male and female participants are eligible. * Histologically or cytologically confirmed as advanced lung cancer (driver gene negative) or advanced solid tumors with lung metastasis, and having failed prior standard treatments or having no standard treatment options. * Agree to provide fresh tumor tissue samples or archived tumor tissue samples within the past three years. * Presence of at least one measurable lesion as defined by RECIST V1.1 * Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-1 * Organ function must be adequate at screening (no need for blood transfusion, hematopoietic growth factors, human albumin, or medications for correction within 14 days prior to first treatment), specifically defined as: a) Hematology: Absolute neutrophil count ≥1.5×10\^9/L; platelet count ≥90×10\^9/L; hemoglobin ≥90 g/L (9 g/dL). b) Liver Function: Serum total bilirubin (TBIL) ≤1.5× upper limit of normal (ULN); for patients with liver metastasis or a history/suspected history of Gilbert's syndrome (persistent or recurrent hyperbilirubinemia, primarily unconjugated bilirubin, with no evidence of hemolysis or liver pathology), TBIL ≤3×ULN; for patients without liver metastasis, alanine aminotransferase (ALT) and aspartate aminotransferase (AST); for patients with liver metastasis, ALT or AST ≤5×ULN. c) Renal Function: Creatinine (Cr) ≤1.5×ULN or creatinine clearance (CLcr) ≥60 mL/min (calculated using the Cockcroft-Gault formula, see Attachment 3); urine dipstick test result showing urinary protein \<2+; for patients with baseline urine dipstick showing protein ≥2+, a 24-hour urine collection should be conducted, and the protein content in the 24-hour urine should be \<1 g. d) Cardiac Function: Echocardiography showing left ventricular ejection fraction (LVEF) \>50%. e) Pulmonary Function: Shortness of breath ≤Grade 1 as per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), and outdoor ambient air oxygen saturation (SpO₂) ≥92%. * Expected life expectancy ≥12 weeks. * Female patients of childbearing potential and male patients (and their female partners) must use highly effective contraception from the screening period until at least 6 months after the last dose of the study drug. Patients must not plan to conceive, donate sperm, or donate eggs during this period Exclusion Criteria: * Patients with lung cancer who have concurrent other types of malignant tumors or are diagnosed with multiple primary malignancies, except for the following: completely resected basal cell carcinoma and squamous cell carcinoma of the skin, completely resected any type of carcinoma in situ. * Symptomatic central nervous system metastasis; for patients with asymptomatic brain metastasis or those whose symptoms have been stable for ≥2 weeks after treatment of brain metastasis, they may participate in this study if they meet all the following criteria: measurable lesions in the lungs; cessation of steroid treatment 14 days prior to the first trial product dose. * Patients with chronic obstructive pulmonary disease (COPD), asthma, or allergies to pollen or dust. * Patients suspected of having active or latent tuberculosis infection, based on interferon-γ release assay results, clinical symptoms, and/or chest imaging findings (patients with evidence of adequately treated prior active tuberculosis infection may be enrolled after assessment by the investigator; for latent tuberculosis, patients must have completed at least 4 weeks of anti-tuberculosis treatment, with no liver function impairment \[ALT ≤3×ULN, AST ≤3×ULN\], and after the investigator assesses that the risk is manageable, they may be considered for continued screening or enrollment). * History of interstitial lung disease (e.g., idiopathic pulmonary fibrosis or organizing pneumonia), or active, non-infectious pneumonia requiring immunosuppressive treatment such as corticosteroids. * Patients with active autoimmune diseases requiring therapeutic intervention. * History of serious bleeding disorders; or those with coagulation dysfunction (as indicated by laboratory tests or medical history) who are deemed by the investigator to be unsuitable for the trial treatment. * History or current diagnosis of cardiovascular disease, including any of the following: a) Recent myocardial infarction or coronary artery bypass grafting (CABG) within the past 6 months; b) Uncontrolled congestive heart failure; c) Unstable angina (within the past 6 months); d) Clinically significant (symptomatic) arrhythmias (e.g., sustained ventricular tachycardia, clinically significant second- or third-degree atrioventricular block without a pacemaker). * Clinically uncontrolled third-space fluid accumulation (e.g., pleural effusion/pericardial effusion; patients with effusions that do not require drainage or those whose effusions have not increased significantly after stopping drainage for 3 days may be included). * Severe infection requiring intravenous antibiotic treatment or hospitalization at screening, or any uncontrolled active infection within 4 weeks prior to the first dose of the trial product. * History of severe allergic reactions, or known allergy to any active or inactive component of BMD006 or PD-1 inhibitors. * Any other metabolic, hematological, renal, hepatic, pulmonary, neurological, endocrine, cardiac, or gastrointestinal disease that, in the investigator's opinion, may present unacceptable risks to the patient during treatment. * Presence of unresolved toxicity from prior anti-tumor treatments before the first dose of the study product, which has not recovered to Grade 0 or 1 (excluding alopecia) (severity assessed according to NCI CTCAE v5.0). * Positive test re
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What it tests

  • BMD006 monotherapy
  • BMD006 in combination with Immuno-Oncology (IO) therapy (Dose Escalation)
  • BMD006 in combination with Immuno-Oncology (IO) therapy (Dose Expansion)
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Where

1 site
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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