Phase 1 Study of Intratumoral Measles Virus MV-s-NAP for Treating Metastatic Breast Cancer

What this Trial Is About

This trial studies patients with invasive metastatic breast cancer to evaluate the side effects and best dose of a modified measles virus called MV-s-NAP. This virus has been altered to produce a specific protein involved in inflammatory reactions and has shown the ability to multiply in and destroy breast cancer cells in lab and animal studies. The research aims to assess safety, toxicity, and preliminary antitumor effects of this treatment delivered directly into tumors. Patients are assigned to one of three groups receiving MV-s-NAP through injections into tumors. One group receives a single treatment, while the others receive repeated treatments every 21 or 14 days for up to 3 cycles, depending on the group. Imaging tests like CT and MRI scans, tumor biopsies, and blood and urine samples are collected during the study to monitor treatment effects and viral activity. Participants undergo thorough assessments including scans, biopsies, and laboratory tests throughout treatment and follow-up. After treatment, patients are followed every 3 months in the first year and every 6 months in the second year to monitor tumor response, immune system activity, and safety. The study measures outcomes such as maximum tolerated dose, tumor response, adverse events, viral presence in blood, and immune responses up to two years.

A Vaccine (MV-s-NAP) for the Treatment of Patients With Invasive Metastatic Breast Cancer