[Translation] A Phase Ib/IIa clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of intratumoral injection and multiple doses of nanocarbon iron suspension injection (CNSI-Fe) in subjects with advanced solid tumors

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。

[Translation]

Phase Ib: Primary purpose: To evaluate the safety and tolerability of CNSI-Fe injected intratumorally at different doses and multiple administrations in subjects with advanced solid tumors. Secondary purpose: To evaluate the PK characteristics of CNSI-Fe injected intratumorally at different doses and multiple administrations in subjects with advanced solid tumors; To evaluate the anti-tumor efficacy of CNSI-Fe injected intratumorally at different doses and multiple administrations in target lesions in subjects with advanced solid tumors. Phase IIa: Primary purpose: To evaluate the anti-tumor activity of CNSI-Fe injected intratumorally at multiple administrations in the target advanced solid tumor cohort. Secondary purposes: ·To evaluate the safety and tolerability of CNSI-Fe injected intratumorally at multiple administrations in the treatment of target advanced solid tumor subjects; ·To further evaluate the overall anti-tumor efficacy of CNSI-Fe injected intratumorally at multiple administrations in the treatment of target advanced solid tumor subjects; ·To further evaluate the anti-tumor efficacy of CNSI-Fe injected intratumorally at multiple administrations in the treatment of target lesions in the treatment of target advanced solid tumor subjects.

Start Date01 Nov 2024

Sponsor / Collaborator

Sichuan Yingrui Pharmaceutical Technology Co., Ltd.

CTR20222235

/ Active, not recruitingPhase 1

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

[Translation] A Phase I clinical study to evaluate the safety, tolerability, pharmacokinetic (PK) characteristics and preliminary efficacy of intratumoral injection of carbon nano-iron suspension injection (CNSI-Fe) in patients with advanced solid tumors

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）。

[Translation]

Primary objective: To evaluate the safety and tolerability of different doses of intratumoral injection of nanocarbon iron suspension injection (CNSI-Fe) in patients with advanced solid tumors, observe the dose-limiting toxicity (DLT) of CNSI-Fe, determine the maximum tolerated dose (MTD) or the highest injection dose in humans, and provide a basis for dose selection for subsequent clinical studies. Secondary objective: To evaluate the pharmacokinetic (PK) characteristics of different doses of intratumoral injection of CNSI-Fe in patients with advanced solid tumors; to preliminarily evaluate the efficacy of different doses of intratumoral injection of CNSI-Fe in patients with advanced solid tumors. Exploratory objective: To evaluate the intratumoral pharmacodynamic (PD) characteristics of different doses of intratumoral injection of CNSI-Fe in patients with advanced solid tumors (not mandatory); to evaluate the intratumoral PK characteristics of different doses of intratumoral injection of CNSI-Fe in patients with advanced solid tumors (not mandatory); to explore the dose-effect relationship between the tumor size of intratumoral injection of CNSI-Fe and the injection dose and administration concentration of CNSI-Fe (not mandatory).

Start Date17 Nov 2022

Sponsor / Collaborator

Sichuan Yingrui Pharmaceutical Technology Co., Ltd.

NCT06048367

/ RecruitingPhase 1

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.

Start Date14 Oct 2022

Sponsor / Collaborator

Sichuan Yingrui Pharmaceutical Technology Co., Ltd.

100 Clinical Results associated with CNSI-Fe

100 Translational Medicine associated with CNSI-Fe

100 Patents (Medical) associated with CNSI-Fe

Literatures (Medical) associated with CNSI-Fe

01 Jun 2025·Colloids and Surfaces B: Biointerfaces

Carbon nanoparticles-Fe(II) complex combined with sorafenib for ferroptosis-induced antitumor effects in triple-negative breast cancer

Article

Author: Yang, Jinmei ; Zeng, Cheng ; Zhao, Yufeng ; Yang, Sheng-Tao ; Tang, Xiaohai ; Zeng, Guangfu ; Xie, Ping ; Tang, Kexin ; Wu, Xian ; Yuan, Huahui ; Qu, Ting ; Xin, Qian ; Huang, Yuanfang

Triple negative breast cancer (TNBC) represents an aggressive subtype of breast cancer that lacks the expression of estrogen receptor, progesterone receptor, and human epidermal growth factor receptor 2, whose systemic treatment options are currently limited to chemotherapy. Carbon nanoparticles-Fe(II) complex (CNSI-Fe) is a promising antitumor drug that induces ferroptosis to kill tumor cells efficiently. In this study, we combined CNSI-Fe and a ferroptosis inducer sorafenib (SRF) to achieve the efficient chemotherapy of TNBC. CNSI-Fe could adsorb SRF by hydrophobic interaction and π-π stacking with a maximum adsorption capacity of 31 mg/g. During the in vitro assays, CNSI-Fe+SRF combination inhibited the cell viability of 4T1 cells much more efficiently than CNSI-Fe or SRF alone. The high Fe uptake, hydroxyl radical generation and oxidative damages verified the ferroptosis of 4T1 cells upon the CNSI-Fe+SRF treatment. During the in vivo evaluations, SRF enhanced the therapeutic effect of CNSI-Fe as indicated by the higher tumor growth inhibition rate of 67.8 % and the higher survival rate. CNSI captured SRF in tumor to give a 6 mg/kg uptake, which lowered the glutathione peroxidase 4 (GPX4) level and enhanced the hydroxyl radical production of 4T1 tumor. In addition, CNSI-Fe treatment up-regulated the genes associated with antioxidative responses, but the up-regulation was offset by SRF. CNSI-Fe+SRF group showed similar toxicity to mice as SRF alone in the biosafety evaluations. Our results collectively indicated that the combination of CNSI-Fe and SRF could efficiently treat TNBC through ferroptosis.

01 Aug 2024·Colloids and Surfaces B: Biointerfaces

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

Article

Author: Yang, Sheng-Tao ; Tang, Kexin ; Yuan, Huahui ; Zhang, Chun ; Zeng, Guangfu ; Tang, Xiaohai ; Xin, Qian ; Gou, Zehui ; 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.

ACS Applied Materials & InterfacesQ2 · MATERIALS SCIENCE

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

Q2 · MATERIALS SCIENCE

Article

Author: 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 Deals associated with CNSI-Fe

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Malignant Solid Neoplasm	Phase 2	China	Sichuan Yingrui Pharmaceutical Technology Co., Ltd.	01 Nov 2024
Breast Cancer	Phase 1	China	Sichuan Yingrui Pharmaceutical Technology Co., Ltd.	14 Oct 2022
Colorectal Cancer	Phase 1	China	Sichuan Yingrui Pharmaceutical Technology Co., Ltd.	14 Oct 2022
Lung Cancer	Phase 1	China	Sichuan Yingrui Pharmaceutical Technology Co., Ltd.	14 Oct 2022
Ovarian Cancer	Phase 1	China	Sichuan Yingrui Pharmaceutical Technology Co., Ltd.	14 Oct 2022
Pancreatic Cancer	Phase 1	China	Sichuan Yingrui Pharmaceutical Technology Co., Ltd.	14 Oct 2022
Thyroid Cancer	Phase 1	China	Sichuan Yingrui Pharmaceutical Technology Co., Ltd.	14 Oct 2022
Uterine Cervical Cancer	Phase 1	China	Sichuan Yingrui Pharmaceutical Technology Co., Ltd.	14 Oct 2022
Vulvar Neoplasms	Phase 1	China	Sichuan Yingrui Pharmaceutical Technology Co., Ltd.	14 Oct 2022

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