We are recruiting patients with advanced solid tumors who have failed standard therapy (disease progression after treatment or treatment intolerance) or who have no effective standard therapy. This trial has been approved by the ethics committees of all participating centers.
Study Title
A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic (PK) Profile, and Preliminary Efficacy of Intratumoral Injection of Carbon Nanoparticle Iron Suspension (CNSI‑Fe) in Patients with Advanced Solid Tumors
Main Inclusion Criteria
1. Understand and voluntarily sign written informed consent (ICF), and be willing and able to comply with all study requirements;
2. Male or female aged 18–75 years (inclusive) at the time of signing ICF;
3. Patients with histologically or cytologically confirmed advanced solid tumors who have failed standard therapy (disease progression or treatment intolerance) or have no effective standard therapy, such as colorectal cancer, pancreatic cancer, breast cancer, gastric cancer, cervical cancer, lung cancer, head and neck cancer (including anaplastic thyroid cancer, medullary thyroid cancer, etc.), cholangiocarcinoma, renal cancer, prostate cancer, vulvar cancer, etc.
Main Exclusion Criteria
1. Past or current history of disorders of iron metabolism (except iron deficiency anemia), such as thalassemia, favism (glucose‑6‑phosphate dehydrogenase deficiency), etc.;
2. Receipt of radiotherapy or any anti‑tumor drug therapy to the target lesion within 4 weeks prior to the first dose of investigational product, or less than 5 half‑lives from the last prior anti‑tumor treatment (including but not limited to chemotherapy, targeted therapy, immunotherapy, NMPA‑approved anti‑tumor Chinese patent medicines, and Chinese herbal medicines with anti‑tumor effects) to the first dose, whichever is shorter;
3. Major surgical procedure (other than for diagnosis), significant trauma, or presence of non‑healing wounds or ulcers within 4 weeks prior to the first dose;
4. Inadequately controlled hypertension (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg);
5. Presence of other malignancies within 5 years prior to the first dose of study treatment, except for non‑melanoma skin cancer, localized prostate cancer, ductal carcinoma in situ or stage I uterine cancer, cervical carcinoma in situ, or breast carcinoma in situ that have received curative treatment;
6. Known allergy or intolerance to the active ingredient, excipients, or other iron supplements of the investigational product.
Your Benefits
1. You will receive the investigational drug for treatment;
2. You will receive all study‑related examinations;
3. You will be covered by clinical trial liability insurance;
4. The sponsor will cover the cost of treatment for trial‑related injuries. Your participation and the data you provide will help advance the development of the investigational drug and make an important contribution to human health.
Contact Information
1. West China Hospital, Sichuan University
Address: No. 37, Guoxue Alley, Wuhou District, Chengdu, Sichuan
Contact: Wu
Phone: 15387681425
2. Enshi Tujia Autonomous Prefecture Central Hospital
Address: No. 158, Wuyang Avenue, Enshi City, Hubei
Contact: Xiang
Phone: 15367707011
3. Shandong First Medical University Affiliated Cancer Hospital (Shandong Cancer Hospital)
Address: No. 440, Jiyan Road, Huaiyin District, Jinan, Shandong
Contact: Zhao
Phone: 13290147889
We will strictly protect your personal information in accordance with regulations. Your participation will contribute to medical scientific progress. We warmly welcome your enrollment.
