Phase 1 Study of SYNC-T Immunotherapy After Controlled Cell Breakdown for Adults With Advanced or Metastatic Solid Tumors

What this Trial Is About

This research aims to evaluate SV-101, a combination immunotherapy designed to overcome the complex mechanisms that allow tumors to evade the immune system. The trial focuses on patients with advanced or metastatic solid tumors, including metastatic breast and lung cancers, for whom standard treatments have failed or are unavailable. The study is a Phase 1 clinical trial assessing the safety and antitumor activity of this regimen. Participants receive SV-101, which is studied for its multiple immune-related effects against tumors. This treatment is given after a controlled cellular lysis procedure to maximize immune response. The trial includes one treatment arm where patients are monitored over time to assess the therapys impact. Treatment is administered under medical supervision, and patients must meet specific health and safety criteria before starting. During the study, participants will undergo evaluations such as imaging scans to measure tumor response, blood tests to monitor organ function, and assessments for adverse events over a one-year period. Researchers will track antitumor activity about 4 to 6 weeks after each treatment. Safety is closely monitored throughout, including serious side effects and reasons for stopping treatment. The total study duration includes regular follow-up visits to ensure comprehensive data collection and participant well-being.

Phase 1 Trial of SYNC-T - Immunotherapy for Patients With Advanced/Metastatic Solid Tumors