Inhaled mRNA Tumor-associated Antigen Dry Powder Vaccine in Advanced Lung Cancer and Lung Metastasis of Solid Tumors.

EARLY_PHASE1RecruitingINTERVENTIONAL
Enrollment

22

Participants

Timeline

Start Date

February 24, 2025

Primary Completion Date

February 24, 2027

Study Completion Date

February 24, 2028

Conditions
Advanced Lung CancerLung Metastasis
Interventions
BIOLOGICAL

BMD006 monotreatment

After receiving the first dose of BMD006 treatment on Day 1, the patient will complete a single-treatment DLT observation (14 days). If the treatment is deemed safe and tolerable by the investigator, the patient will proceed to multiple-treatment DLT observation (14 days), with BMD006 treatment administered on Day 15 and Day 22. On Day 28, if the treatment is again assessed as safe and tolerable by the investigator, the patient will continue treatment at the current dose level following a QW (once weekly) regimen for 6 doses. After that, starting from Week 11, the treatment schedule will change to Q3W (once every 3 weeks) until 52 weeks after the first treatment or until the treatment discontinuation criteria are met.

BIOLOGICAL

BMD006 in combination with PD-1 antibody

Once the dose escalation of BMD006 monotreatment is completed and the MTD (Maximum Tolerated Dose) is determined (i.e., the RP2D for this study), a dose escalation exploration of BMD006 in combination with PD-1 antibody will be conducted. On Day 1, patients will receive BMD006 in combination with PD-1 antibody treatment, followed by BMD006 treatment on Days 8 and 15. The DLT observation period will be 21 days. On Day 21, if the treatment is assessed as safe and tolerable by the investigator, the patient will continue treatment at the current dose level according to the QW (once weekly) regimen for 6 doses. After Week 10, the treatment schedule will change to Q3W (once every 3 weeks) until 52 weeks after the first treatment or until the treatment discontinuation criteria are met.

Trial Locations (1)

Unknown

RECRUITING

Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Beijing

All Listed Sponsors
lead

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

OTHER