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RECRUITING
NCT06928922
EARLY_PHASE1

mRNA Vaccine for Advanced Lung Cancer and Pulmonary Metastases of Solid Tumors

Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

View on ClinicalTrials.gov

Summary

BMD006 is an off-the-shelf antitumor mRNA vaccine targeting lung cancer and lung metastatic solid tumors. This is a single-center, open-label, dose-escalation clinical trial. The study aims to evaluate the safety, tolerability, preliminary efficacy, pharmacokinetic (PK), and pharmacodynamic (PD) profiles of BMD006 in patients with advanced lung cancer or advanced solid tumors with lung metastasis who have progressed on or are ineligible for standard therapeutic options. This trial also further explores the clinical efficacy of BMD006 in combination with Immuno-Oncology (IO) therapy.

Official title: The Phase I Clinical Study of mRNA Vaccine BMD006 in Patients With Advanced Lung Cancer or Pulmonary Metastatic Solid Tumors

Key Details

Gender

All

Age Range

Any - 99 Years

Study Type

INTERVENTIONAL

Enrollment

83

Start Date

2025-02-24

Completion Date

2028-02-24

Last Updated

2026-10-26

Healthy Volunteers

No

Interventions

BIOLOGICAL

BMD006 monotherapy

Following the initial BMD006 administration, subjects will undergo DLT observation for single treatment. If investigators confirm acceptable safety and tolerability, subjects will enter DLT observation for multiple treatment. After satisfactory safety assessment, subjects will continue treatment at the assigned dose until 52 weeks after the first administration or until meeting treatment discontinuation criteria.

BIOLOGICAL

BMD006 in combination with Immuno-Oncology (IO) therapy (Dose Escalation)

Once the dose escalation of BMD006 monotherapy is completed and the MTD (Maximum Tolerated Dose) is determined (i.e., the RP2D for this study), dose escalation exploration of BMD006 in combination with Immuno-Oncology (IO) therapy will be initiated. Subjects will undergo DLT observation. If investigators confirm acceptable safety and tolerability, subjects will continue treatment at the assigned dose until 52 weeks after the first administration or until meeting treatment discontinuation criteria.

BIOLOGICAL

BMD006 in combination with Immuno-Oncology (IO) therapy (Dose Expansion)

Group 1 receives combination therapy with BMD006 and Immuno-Oncology (IO) therapy. Group 2 receives BMD006 monotherapy initially. After the initial treatment phase, investigators will assess potential clinical benefits, and IO therapy will be added for combined treatment thereafter.

Locations (1)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, China