RecruitingEarly Phase 1NCT06928922

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

The Phase I Clinical Study of the Inhaled mRNA Tumor-associated Antigen Dry Powder Vaccine BMD006 in Patients With Advanced Lung Cancer or Metastatic Solid Tumors in the Lungs.

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Enrollment

83 participants

Start Date

Feb 24, 2025

Study Type

INTERVENTIONAL

Conditions

Advanced Lung Cancer Lung Metastasis

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

Max Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new type of inhaled vaccine for advanced lung cancer or solid tumors that have spread to the lungs. The vaccine is delivered as a dry powder through inhalation and aims to train the immune system to fight cancer cells. **You may be eligible if...** - You are 18 years or older - You have advanced lung cancer (without targetable gene mutations) or another solid tumor that has spread to the lungs - Standard treatments have not worked or are not available for you - You have at least one measurable tumor - You are in good general health (able to carry out light daily activities) - Your blood counts and organ function meet required levels **You may NOT be eligible if...** - You have had a serious immune-related reaction to prior cancer therapy - You have active autoimmune disease, severe lung disease, or brain metastases requiring steroids - You are pregnant or breastfeeding - You are unable to provide a tumor tissue sample Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALBMD006 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.

BIOLOGICALBMD006 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.

BIOLOGICALBMD006 in combination with PD-1/VEGF antibody

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