纳米炭铁混悬注射液(CNSI-Fe) - 在研适应症：晚期恶性实体瘤，乳腺癌，结直肠癌_专利_临床

概要

基本信息

药物类型

小分子化药

别名-

靶点-

作用机制-

治疗领域

肿瘤消化系统疾病内分泌与代谢疾病+ [4]

在研适应症

晚期恶性实体瘤乳腺癌结直肠癌+ [6]

非在研适应症-

原研机构

四川瀛瑞医药科技有限公司

在研机构

四川瀛瑞医药科技有限公司

非在研机构-

最高研发阶段临床1/2期

首次获批日期-

最高研发阶段(中国)临床1/2期

特殊审评-

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关联

3

项与纳米炭铁混悬注射液相关的临床试验

CTR20243192 / Not yet recruiting临床1/2期

一项评价纳米炭铁混悬注射液（CNSI-Fe）瘤内注射、多次给药在晚期实体瘤受试者中的安全性、耐受性、药代动力学特征和初步有效性的Ib/IIa期临床研究

Ib期：主要目的：评估瘤内注射不同剂量、多次给药CNSI-Fe在晚期实体瘤受试者中的安全性和耐受性。次要目的：评估瘤内注射不同剂量、多次给药CNSI-Fe在晚期实体瘤受试者中的PK特征；评估瘤内注射不同剂量、多次给药CNSI-Fe在晚期实体瘤受试者中目标病灶的抗肿瘤有效性。 IIa期：主要目的：在目标晚期实体瘤队列中，评价CNSI-Fe瘤内注射、多次给药的抗肿瘤活性。次要目的： ·评估CNSI-Fe瘤内注射、多次给药治疗目标晚期实体瘤受试者的安全性和耐受性； ·进一步评估CNSI-Fe瘤内注射、多次给药治疗目标晚期实体瘤受试者的总体抗肿瘤有效性； ·进一步评估CNSI-Fe瘤内注射、多次给药治疗目标晚期实体瘤受试者中目标病灶的抗肿瘤有效性。

开始日期-

申办/合作机构

四川瀛瑞医药科技有限公司

CTR20222235 / Recruiting临床1期

一项评估纳米炭铁混悬注射液（CNSI-Fe）瘤内注射在晚期实体瘤患者中的安全性、耐受性、药代动力学（PK）特征和初步疗效的I期临床研究

主要目的：评估瘤内注射不同剂量的纳米炭铁混悬注射液（CNSI-Fe）在晚期实体瘤患者中的安全性和耐受性，并观察CNSI-Fe的剂量限制性毒性（DLT），确定在人体的最大耐受剂量（MTD）或最高注射剂量，为后续临床研究提供剂量选择依据。次要目的：评估瘤内注射不同剂量的CNSI-Fe在晚期实体瘤患者中的药代动力学（PK）特征；初步评估瘤内注射不同剂量的CNSI-Fe在晚期实体瘤患者中的疗效。探索性目的：评估瘤内注射不同剂量的CNSI-Fe在晚期实体瘤患者中的瘤内药效动力学（PD）特征（不作强制要求）；评估瘤内注射不同剂量的CNSI-Fe在晚期实体瘤患者中的瘤内PK特征（不作强制要求）；探索瘤内注射CNSI-Fe的瘤体大小与CNSI-Fe注射剂量、给药浓度间的量效关系（不作强制要求）。

开始日期2022-11-17

申办/合作机构

四川瀛瑞医药科技有限公司

NCT06048367 / Recruiting临床1期

Carbon Nanoparticle-Loaded Iron [CNSI-Fe(II)] Dose Escalation Study for the Treatment of Advanced Solid Tumors: Phase 1 Clinical Trial

This Phase I clinical trial aims to evaluate the safety, tolerability, pharmacokinetics (PK) profile and preliminary efficacy of intratumoral injection of Carbon Nanoparticle-Loaded Iron [CNSI-Fe(II)] in patients with advanced solid tumors. The study also aims to observe dose-limiting toxicities (DLT) of CNSI-Fe(II) to determine the maximum tolerated dose (MTD) or the highest injectable dose in humans, providing dosing guidelines for future clinical studies. CNSI-Fe(II) shows promise as an innovative tumor therapeutic agent due to its unique properties of ferroptosis. The study primarily focuses on assessing the potential efficacy of CNSI-Fe(II) in patients with advanced solid tumors, particularly in patients with Kras mutation, e.g., pancreatic cancer patients.

开始日期2022-10-14

申办/合作机构

四川瀛瑞医药科技有限公司

100 项与纳米炭铁混悬注射液相关的临床结果

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100 项与纳米炭铁混悬注射液相关的转化医学

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100 项与纳米炭铁混悬注射液相关的专利（医药）

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3

项与纳米炭铁混悬注射液相关的文献（医药）

2024-08-01·Colloids and Surfaces B: Biointerfaces

Photothermal therapy of xenografted tumor by carbon nanoparticles-Fe(II) complex

Article

作者: Yang, Sheng-Tao ; Tang, Kexin ; Yuan, Huahui ; Zhang, Chun ; Zeng, Guangfu ; Tang, Xiaohai ; Gou, Zehui ; Xin, Qian ; Xie, Ping ; Qu, Ting ; Yang, Jinmei ; Zeng, Cheng ; Huang, Yuanfang ; Zhao, Yufeng

Due to the unique structure, carbon nanomaterials could convert near-infrared (NIR) light into heat efficiently in tumor ablation using photothermal therapy (PTT). However, none of them has been applied in clinical treatment, because they have not been approved for clinical evaluations and the precise temperature control facility is scarce. In this study, we designed a temperature-responsive controller for PTT and used carbon nanoparticles-Fe(II) complex (CNSI-Fe) as photothermal conversion agent (PTA) for PTT of tumor in vitro and in vivo. CNSI-Fe was an innovative drug under the evaluations in clinical trials. CNSI-Fe showed excellent photothermal conversion ability in water to increase the water temperature by 40 °C within 5 min under irradiation of 808 nm laser at 0.5 W/cm². The temperature was precisely controlled at 52 °C for both in vitro and in vivo tumor inhibition. CNSI-Fe with NIR irradiation showed higher tumor cell inhibition than CNSI. In tumor bearing mice, CNSI-Fe with NIR irradiation achieved an inhibition rate of 84.7 % and 71.4 % of them were completely cured. Mechanistically, CNSI-Fe under NIR irradiation induced the radical generation, oxidative damage and ferroptosis to kill tumor. In addition, CNSI-Fe showed good biosafety during PTT according to hematological, serum biological and histopathological examinations. These results indicated that the combination of chemotherapy and PTT provided higher antitumor efficiency using CNSI-Fe as PTA.

2021-11-01·Journal of Materials Research and Technology

Application of green synthesised copper iodide particles on cotton fabric-protective face mask material against COVID-19 pandemic

Article

作者: Rajagopal, Revathy ; Archana, K M ; Krishnaswamy, Veena Gayathri ; Aishwarya, S

Microorganisms cause variety of diseases that constitutes a severe threat to mankind. Due to the upsurge of many infectious diseases, there is a high requirement and demand for the development of safety products finished with antimicrobial properties. The study involves the antimicrobial activity of natural cotton coated with copper iodide capped with Hibiscus rosa-sinensis L. flower extract (CuI-FE) which is rich in anthocyanin, cyanidin-3-sophoroside by ultrasonication method. The coated and uncoated cotton fabric was characterised through XRD, SEM, AFM, tensile strength and UV-Visible spectroscopic techniques. XRD confirmed the formation of CuI particles, SEM showed that CuI-FE was prismatic in shape. The average size of CuI-FE particles was found to be 552.45 nm. Anti-bacterial studies showed copper iodide particles to be a potent antimicrobial agent. AFM images confirmed the rupture of bacterial cell walls in the presence of prismatic CuI-FE. In-vitro cytotoxicity investigation of CuI-FE was performed against cancer and spleen cell lines to evaluate the cell viability. Cytotoxicity analysis revealed the IC₅₀ value of 233.93 μg/mL in the presence of CuI-FE. Molecular docking study was also carried out to understand the interaction of CuI-FE with COVID-19 main protease. This paper has given an insight on the usage of CuI-FE coated on the cotton fabric that has proved to have strong inhibition against the nano ranged bacterial, cancerous cell line and a strong interaction with the COVID-19 protease. Such eco-friendly material will provide a safe environment even after the disposable of medical waste from the infectious diseases like influenza and current pandemic like COVID-19.

ACS Applied Materials & Interfaces2区 · 材料科学

Carbon Nanoparticles–Fe(II) Complex for Efficient Tumor Inhibition with Low Toxicity by Amplifying Oxidative Stress

2区 · 材料科学

Article

作者: Zeng, Guangfu ; Xin, Qian ; Yang, Sheng-Tao ; Huang, Yuanfang ; Xie, Ping ; Xia, Pingfang ; Tang, Kexin ; Zeng, Cheng ; Tang, Xiaohai ; Yang, Shengnan

The Fe element is essential for human beings, but overdose of Fe leads to unwanted toxicity. However, overwhelming Fe accumulation in tumor cells could arouse strong oxidative stress for cancer therapy. Therefore, the fast and specific accumulation of Fe in tumor cells without systemic toxicity is critical for this purpose. Herein, we report that a carbon nanoparticles-Fe(II) complex (CNSI-Fe) could efficiently load Fe into tumor cells and inhibit tumor growth with low toxicity in H22 tumor-bearing mice. Upon intratumoral injection, CNSI-Fe only induced meaningful Fe increase in the tumor to significantly inhibit tumor growth with competitive efficiency to cis-dichlorodiammineplatinum(II). Fe accumulation stimulated the hydroxyl radical generation and serious oxidative stress in the tumor. Due to the lack of Fe accumulation in other tissues, CNSI-Fe was of low systemic toxicity to tumor-bearing mice. With the clinical success of CNSI for decades, CNSI-Fe might be used for cancer therapy through "off label" use to benefit patients immediately.

100 项与纳米炭铁混悬注射液相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
晚期恶性实体瘤	临床2期	中国	四川瀛瑞医药科技有限公司	2024-08-22
乳腺癌	临床1期	中国	四川瀛瑞医药科技有限公司	2022-10-14
结直肠癌	临床1期	中国	四川瀛瑞医药科技有限公司	2022-10-14
肺癌	临床1期	中国	四川瀛瑞医药科技有限公司	2022-10-14
卵巢癌	临床1期	中国	四川瀛瑞医药科技有限公司	2022-10-14
胰腺癌	临床1期	中国	四川瀛瑞医药科技有限公司	2022-10-14
甲状腺癌	临床1期	中国	四川瀛瑞医药科技有限公司	2022-10-14
宫颈癌	临床1期	中国	四川瀛瑞医药科技有限公司	2022-10-14
外阴肿瘤	临床1期	中国	四川瀛瑞医药科技有限公司	2022-10-14