Phase IbIIa Study Evaluating Safety and Effectiveness of Carbon Nanoparticle-Loaded Iron Injection for Advanced Solid Tumors

What this Trial Is About

Researchers are evaluating CNSI-Fe, an innovative anti-cancer drug containing Fe2 loaded on carbon nanoparticles, in people with advanced solid tumors. CNSI-Fe works by regulating a cell death process called ferroptosis and aims to improve cancer treatment through intratumoral injections. This Phase IbIIa study follows an initial Phase I trial where different doses showed promising safety and disease control in various advanced solid tumor patients. Participants will receive CNSI-Fe injections directly into 1 to 3 tumor lesions every two weeks for a total of 4 doses, with the possibility of additional doses if the benefits outweigh risks. The study includes a screening period, treatment period, and follow-up phase. Tumor response and safety will be closely monitored, and injections will stop or switch lesions based on tumor shrinkage or disappearance. During the study, participants will undergo safety checks before each dose and tumor evaluations at specified intervals, including before the third dose, after the fourth dose, and every six weeks thereafter. Follow-up includes safety monitoring 28 days after the last dose and regular checks for disease progression until new treatment, death, or study end. Samples will be collected at scheduled visits to assess safety, drug levels, and anti-tumor effects.

Carbon Nanoparticle-Loaded Iron in the Treatment of Advanced Solid Tumor