OncoMatch/Clinical Trials/NCT07433283
Carbon Nanoparticle-Loaded Iron in the Treatment of Advanced Solid Tumor
Is NCT07433283 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Carbon Nanoparticle-Loaded Iron [CNSI-Fe] and Carbon Nanoparticle-Loaded Iron for tumor, solid.
Treatment: Carbon Nanoparticle-Loaded Iron [CNSI-Fe] · Carbon Nanoparticle-Loaded Iron — 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 observed in 1 subject (30 mg group), complete tumor response (CR) was observed in 1 subject (60 mg group), and stable tumor (SD) was observed in 11 subjects (including 1 in the 30 mg group, 2 in the 60 mg group, 5 in the 90 mg group, and 3 in the 120 mg group), and the disease control rate (DCR) of the trial treatment was 87%. This Phase I clinical study is planned to continue dose exploration at 150 mg or higher. Therefore, based on the results of the Phase I clinical trial obtained, it is planned to conduct this Phase Ib/IIa clinical study in subjects with advanced solid tumors in China to further evaluate the safety, tolerability, pharmacokinetic (PK) characteristics and preliminary efficacy of CNSI-Fe intratumoral injection and multiple administration, so as to provide a basis for clinical development in the later stage.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Pancreatic Cancer
Thyroid Cancer
Colorectal Cancer
Cervical Cancer
Disease stage
Required: Stage IB
Metastatic disease required
Stage Ib: patients with advanced solid tumors confirmed by histology or cytology, and the current standard therapy is ineffective (disease progression after treatment or treatment is not tolerated) or there is no effective standard treatment
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: standard therapy
current standard therapy is ineffective (disease progression after treatment or treatment is not tolerated) or there is no effective standard treatment
Cannot have received: systemic chemotherapy
Systemic chemotherapy ... within 3 weeks prior to the first dose of study drug
Cannot have received: targeted therapy
targeted therapy ... within 3 weeks prior to the first dose of study drug
Cannot have received: anti-tumor biologic therapy
anti-tumor biologic therapy ... within 3 weeks prior to the first dose of study drug
Cannot have received: immunotherapy
immunotherapy within 3 weeks prior to the first dose of study drug
Cannot have received: radiation therapy
Exception: CNS radiotherapy requires a washout period of ≥ 28 days
Prior radiotherapy within 14 days prior to the first dose of study drug (with the exception of central nervous system [CNS] radiotherapy, which requires a washout period of ≥ 28 days)
Cannot have received: traditional Chinese medicine with anti-tumor indications
Received traditional Chinese medicine with anti-tumor indications within 2 weeks before the first dose of the study drug
Lab requirements
Blood counts
ANC ≥ 1.5×10^9/L; PLT ≥ 90×10^9/L; Hb ≥ 90 g/L; No G-CSF within 14 days, no platelet transfusion/IL-11/rhTPO before labs, no blood transfusion/erythropoietin within 14 days
Kidney function
Serum creatinine (Cr) ≤ 1.5× ULN or 50 mL/min (Cr only) calculated using the Cockcroft-Gault formula
Liver function
TBIL ≤ 1.5× ULN (3.0 ≤× ULN for subjects with Gilbert's syndrome or liver metastases); AST, ALT, and ALP≤3×ULN, and subjects with confirmed liver metastases or bone metastases must meet the following conditions: Subjects with confirmed liver metastases: AST and ALT≤5×ULN; Subjects with confirmed bone metastases: ALP≤5×ULN; serum albumin≥ 2.8 g/dL
Cardiac function
Left ventricular ejection fraction (LVEF) ≥50%
adequate hematologic and end-organ function with laboratory tests meeting the following criteria: ... see full criteria above
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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