Condition: Tumor, Solid · Lung Cancer · Pancreas Cancer · Sponsor: Sichuan Enray Pharmaceutical Sciences Company
Independently developed by Sichuan Yingrui Pharmaceutical Technology Co., Ltd., CNSI-Fe is an innovative anti-cancer drug with Fe2+ as the active ingredient, which exerts anti-tumor effects by regulating the ferroptosis pathway. CNSI-Fe intratumoral injection has the following three effects: 1. Nanocarbon can increase the content of hydrogen peroxide in tumor cells and tumor microenvironment, and is a reactive oxygen species that catalyzes hydrogen peroxide through the Fenton reaction of iron ions to produce "ferroptosis", which complements each other; 2. The adsorption of Fe2+ by nanocarbon can help Fe2+ better enter the cell, thereby exerting anti-tumor effects; 3. The lesion localization and lymphatic tracing functions of nanocarbon are retained. The combination of the regulatory mechanism of ferroptosis and the characteristics of nanocarbon particles has increased the advantages of new nanopharmaceuticals in cancer prevention and treatment. At present, CNSI-Fe has carried out a first-in-human phase I clinical trial of dose escalation in subjects with advanced solid tumors in China, and has conducted safety and efficacy exploration in four dose groups, including: 30 mg, 60 mg, 90 mg, and 120 mg, and the overall safety and tolerability of the 16 subjects enrolled have been good, no obvious liver and kidney impairment and hematologic toxicity have been observed, and only one subject in the 90 mg dose group has a dose-limiting toxicity (DLT) event; Partial response (PR) was …
This description comes directly from the study's public registry record.
Xiaohai Tang, PhD & MD · +86 13880881962 · pharmmateceo@enraypharm.com
Yan Chen, Bachelor's · +86 17308142669 · chenyan@enraypharm.com
Always discuss trial participation with your own doctor first.
| Peking Union Medical College Hospital | Beijing, Beijing Municipality, China | Not Yet Recruiting |
| Hunan Provincial Tumor Hospital | Hunan, Changsha, China | Not Yet Recruiting |
| The First Affiliated Hospital of Chongqing Medical University | Chongqing, Chongqing Municipality, China | Recruiting |
| Fujian provincial cancer hospital | Fuzhou, Fujian, China | Not Yet Recruiting |
| Second Affiliated Hospital of Hainan Medical University | Haikou, Hainan, China | Recruiting |
| Harbin medical university cancer hospital | Heilongjiang, Harbin, China | Not Yet Recruiting |
| Fudan University Shanghai Cancer Center | Shanghai, Shanghai Municipality, China | Not Yet Recruiting |
| West China Hospital, Sichuan University | Chengdu, Sichuan, China | Recruiting |
| The First Affiliated Hospital of Zhengzhou University | Henan, Zhengzhou, China | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07433283