Treatment of Advanced Endocrine Tumors Using Personalized mRNA Neoantigen Vaccine mRNA-0523-L001 Evaluating Safety and Early Effectiveness in Patients Who Have Failed Standard Treatments

What this Trial Is About

Researchers are evaluating an individualized mRNA neoantigen vaccine mRNA-0523-L001 for treating advanced endocrine tumors, including adrenal cortical carcinoma, medullary thyroid carcinoma, thymic neuroendocrine tumor, and pancreatic neuroendocrine tumor. These tumors often show somatic mutations and tumor-specific neoantigens, making the vaccine a promising option for patients who have failed standard treatments or have no standard options available. The study aims to assess the safety, tolerability, and preliminary efficacy of this vaccine in these challenging cancers. The vaccine is given as an intramuscular injection every 21 days for up to nine cycles. Initially, three patients will receive escalating doses to identify the maximum tolerated dose MTD. Subsequently, 18 more patients will receive the vaccine at the MTD for all nine cycles. Treatment may continue beyond this if an objective response is observed, following specific discontinuation criteria. Participants will undergo safety and immune response monitoring at the end of each 21-day cycle, including evaluation of dose-limiting toxicity, treatment-related adverse events, and immune responses of antigen-specific T cells. Tumor response rates, disease control rates, and progression-free survival will also be assessed. The study involves regular visits and procedures to carefully track treatment effects and patient health over the course of the vaccine administration.

Treatment of Advanced Endocrine Tumor With Iindividualized mRNA Neoantigen Vaccine (mRNA-0523-L001)