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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
[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.
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).
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.
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