First-in-human phase 1 trial reports safety data for an injected ferroptosis therapy in solid tumours

A first-in-human phase 1 trial published in Signal Transduction and Targeted Therapy on 1 October 2026 reports safety and early response data for CNSI-Fe, an experimental carbon nanoparticle-iron complex injected directly into solid tumours to trigger ferroptosis. Nineteen patients with refractory solid tumours received five dose levels (30-150 mg). The paper reports that the maximum tolerated dose was not reached, that one patient had a dose-limiting toxicity, and that the most common side effects were injection-site pain, high blood pressure, raised serum iron and anaemia. The authors report an overall response rate of 10.5% and a disease control rate of 84.2%, and call for a phase 2 trial (NCT06048367).