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.
This study adopts a single center, open label, dose escalation design to evaluate the safety, tolerability, preliminary efficacy, PK and PD characteristics of BMD006 in patients with advanced lung cancer or advanced solid tumors with lung metastasis who have failed standard treatment or have no standard treatment, and to explore the treatment of BMD006 PD-1 or PD-1/VEGF. This study includes three parts: exploring the dosage of BMD006 alone, exploring the dosage of BMD006 combined with PD-1 or PD-1/VEGF, and expanding the dosage of BMD006 combined with PD-1/VEGF.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
83
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.
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.
The 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
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, China
RECRUITINGNumber of participants experiencing dose-limiting toxicities(DLTs)
Number of participants experiencing dose-limiting toxicities(DLTs)
Time frame: about 2 years
Determine the maximum tolerated dose(MTD) of BMD006
Determine the maximum tolerated dose(MTD) of BMD006
Time frame: about 2 years
Determine the recommended phase II dose (RP2D) for the clinical study.
Determine the recommended phase II dose (RP2D) for the clinical study.
Time frame: about 2 years
number of participants experiencing adverse events(AEs)
number of participants experiencing adverse events(AEs)
Time frame: about 2 years
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
Time frame: Up to 12 months
Disease Control Rate(DCR)
The percentage of patients who achieved CR, PR, or SD)as assessed by investigators based on RECIST V1.1.
Time frame: Up to 12 months
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;
Time frame: Up to 12 months
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;
Time frame: Up to 12 months
Overall Survival(OS)
The time between the first treatment date and the date of the patient's death due to any reason.
Time frame: Up to 12 months
The 6-month and 12-month overall survival (OS) rates.
The 6-month and 12-month overall survival (OS) rates.
Time frame: Up to 6 or 12 months
The proportion and activation status of antigen-specific T cells in peripheral blood and tumor tissue (if available)
The proportion and activation status of antigen-specific T cells in peripheral blood and tumor tissue (if available)
Time frame: about 2 years
The titers of antigen-specific antibodies IgG and IgA in serum
The titers of antigen-specific antibodies IgG and IgA in serum
Time frame: about 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.