Carbon nanoparticle-Fe (II) complex for ferroptosis therapy in refractory solid tumors: a phase I trial.
Signal Transduct Target TherOct 1, 2026 (epub)
Huashan Shi, Ping Xie, Xiaoyu Li et al.
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In 30 seconds
This phase I trial evaluated the safety and preliminary efficacy of a carbon nanoparticle-Fe (II) complex (CNSI-Fe) in 19 patients with refractory solid tumors. The maximum tolerated dose was not reached, with only one dose-limiting toxicity reported. The overall response rate was 10.5%, while the disease control rate was 84.2%, reaching 100% in patients with lymph node and sarcoma lesions.
Key findings
- The maximum tolerated dose was not reached, with only one patient experiencing dose-limiting toxicity.
- Common adverse events included injection site pain (89.5%) and hypertension (52.6%).
- The overall response rate was 10.5%, and the disease control rate was 84.2%.
- Peak serum concentrations of iron ranged from 3520.33 to 13961.67 ng/mL.
Why it matters
The findings suggest that CNSI-Fe has a favorable safety profile and potential antitumor activity, indicating its promise for further investigation in refractory solid tumors. Understanding its effects could inform future treatment strategies.