NCT06928922 Inhaled mRNA Tumor-associated Antigen Dry Powder Vaccine in Advanced Lung Cancer and Lung Metastasis of Solid Tumors.
| NCT ID | NCT06928922 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences |
| Condition | Advanced Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 83 participants |
| Start Date | 2025-02-24 |
| Primary Completion | 2027-02-24 |
Trial Parameters
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Brief Summary
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.
Eligibility Criteria
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)
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