Phase 12 Study of N17350 Injections Into Tumors for Adults With Advanced Solid Tumors

What this Trial Is About

Researchers are evaluating the investigational medicine N17350 in adults with advanced solid tumors that have spread or cannot be removed by surgery and for which standard treatments are no longer effective or available. This Phase 12 open-label study aims to assess the safety of N17350, find the best dose for future studies, and observe early signs of how the treatment affects tumors. The study involves participants with various tumor types, including breast, skin, lung, and head and neck cancers. Participants will receive injections of N17350 directly into tumor lesions every two weeks for 8 to 12 weeks. The study has two parts dose finding, where small groups receive increasing doses to determine safety and optimal dose, and dose expansion, where additional participants receive the selected dose to further evaluate safety and treatment activity. Injections are given into accessible tumor lesions, either superficial or visceral, with dosing tailored by lesion type. Throughout the study, participants will attend regular clinic visits for treatment and monitoring. Researchers will perform blood tests, urine tests, physical exams, heart monitoring, and review medications and overall health. Imaging scans like CT or MRI will measure tumor response. Blood and tumor samples may be collected to study how N17350 affects the tumor and immune system. The main outcomes include safety, tumor response, and determining the best dose for future research. The study lasts up to about 12 weeks of treatment with follow-up assessments extending up to 15 months.

Intratumoral N17350 in Advanced Solid Tumors