Actively Recruiting
Carbon Nanoparticle-Loaded Iron in the Treatment of Advanced Solid Tumor
Led by Sichuan Enray Pharmaceutical Sciences Company · Updated on 2026-02-25
54
Participants Needed
9
Research Sites
111 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Carbon Nanoparticle-Loaded Iron in the Treatment of Advanced Solid Tumor
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Understand and voluntarily sign the informed consent form and agree to comply with all trial requirements
- Male or female aged 18 to 80 years at the time of signing informed consent
- Advanced solid tumors confirmed by histology or cytology with ineffective standard therapy or no effective standard treatment
- At least one measurable lesion per RESICT v1.1 that has not had recent radiotherapy or biopsy
- Have injectable lesions suitable for repeated intratumoral injection as judged by the investigator
- ECOG performance score of 0 to 1 within 7 days before the first dose
- Expected survival of at least 3 months
- Prior therapy adverse reactions recovered to CTCAE v5.0 grade 1 or below before screening
- Left ventricular ejection fraction of 50% or higher
- Adequate blood counts and organ function within 7 days before first dose, meeting specific laboratory criteria
- Female subjects of childbearing potential must have a negative pregnancy test and commit to contraception or abstinence during and for 6 months after treatment
- Male subjects must commit to contraception or abstinence during and for 6 months after treatment and agree not to donate sperm during this period
You will not qualify if you...
- Previous or current diseases with abnormal iron metabolism except iron deficiency anemia
- Signs of perforation of hollow viscera at injection site
- Local skin breakdown, redness, swelling, necrosis, or bleeding at injection site
- Recent systemic chemotherapy, targeted therapy, biologic therapy, immunotherapy, or radiotherapy within specified washout periods
- Major surgery within 4 weeks prior or unhealed wounds except minor surgeries fully recovered
- Untreated or active brain or spinal cord metastases or carcinomatous meningitis unless stable and controlled
- Uncontrolled hypertension or tumor-related pain
- Uncontrolled effusions requiring repeated drainage
- Active malignancy within 5 years except certain localized cancers treated curatively
- Live virus vaccination within 4 weeks prior to first dose except inactivated influenza vaccine
- History of immunodeficiency or organ transplantation
- Active hepatitis B, hepatitis C infection, or positive HIV status
- Severe infection requiring systemic therapy prior to treatment
- History of severe cardiac events or significant cardiac disease within 6 months
- Active psychiatric disorders such as schizophrenia or major depression
- Known allergy or intolerance to study drug ingredients
- Participation in other interventional clinical studies within 3 weeks prior
- Other conditions judged unsuitable by the investigator
AI-Screening
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Trial Site Locations
Total: 9 locations
1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100005
Not Yet Recruiting
2
Hunan Provincial Tumor Hospital
Hunan, Changsha, China, 410000
Not Yet Recruiting
3
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China, 400042
Actively Recruiting
4
Fujian provincial cancer hospital
Fuzhou, Fujian, China, 350014
Not Yet Recruiting
5
Second Affiliated Hospital of Hainan Medical University
Haikou, Hainan, China, 571626
Actively Recruiting
6
Harbin medical university cancer hospital
Heilongjiang, Harbin, China, 150081
Not Yet Recruiting
7
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Not Yet Recruiting
8
West China Hospital, Sichuan University
Chengdu, Sichuan, China, 610041
Actively Recruiting
9
The First Affiliated Hospital of Zhengzhou University
Henan, Zhengzhou, China, 450052
Actively Recruiting
Research Team
X
Xiaohai Tang, PhD & MD
CONTACT
Y
Yan Chen, Bachelor's
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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