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.
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.
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).
Sequential
BMD006 monotreatment
Biological/VaccineAfter 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.
BMD006 in combination with PD-1 antibody
Biological/VaccineOnce 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.
BMD006 in combination with PD-1/VEGF antibody
Biological/VaccineThe first group is a combination therapy of BMD006 and PD-1/VEGF. BMD006 was administered once a week for the first six weeks, and adjusted to once every three weeks starting from the seventh week. PD-1/VEGF was administered once every three weeks. The second group received BMD006 monotherapy once a week. After six doses, the researchers evaluated the potential benefits and started using PD-1/VEGF in combination from the seventh week onwards. BMD006 was then administered every three weeks, and PD-1/VEGF was administered every three weeks thereafter
Number of participants experiencing dose-limiting toxicities（DLTs）
Number of participants experiencing dose-limiting toxicities（DLTs）
Determine the maximum tolerated dose（MTD） of BMD006
Determine the maximum tolerated dose（MTD） of BMD006
Determine the recommended phase II dose (RP2D) for the clinical study.
Determine the recommended phase II dose (RP2D) for the clinical study.
number of participants experiencing adverse events（AEs）
number of participants experiencing adverse events（AEs）
overall response rate（ORR）
The percentage of patients who achieved the best overall response of complete response (CR) or partial response (PR) as evaluated by investigators based on RECIST V1.1
Disease Control Rate(DCR)
The percentage of patients who achieved CR, PR, or SD)as assessed by investigators based on RECIST V1.1.
Duration of Response(DOR)
The investigators evaluated the time from objective remission to the first recorded disease progression or death (whichever occurred first) based on RECIST V1.1;
Progression-Free Survival (PFS)
The time between the first treatment date and the date of the first recorded disease progression or death (whichever occurs first) evaluated by the investigator according to RECIST V1.1;
Copy number of BMD006 mRNA in serum
Copy number of BMD006 mRNA in serum
Circulating tumor DNA (ctDNA) levels in patients with advanced lung cancer or advanced solid tumors with lung metastasis.
Circulating tumor DNA (ctDNA) levels in patients with advanced lung cancer or advanced solid tumors with lung metastasis.
The incidence of dose-limiting toxicity (DLT) after treatment with BMD006 in combination with PD-1 antibody
The incidence of dose-limiting toxicity (DLT) after treatment with BMD006 in combination with PD-1 antibody
The incidence of Adverse Events (AEs) after treatment with BMD006 in combination with PD-1 antibody
The incidence of Adverse Events (AEs) after treatment with BMD006 in combination with PD-1 antibody
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