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New treatment option for Tumor, Solid
Official title Carbon Nanoparticle-Loaded Iron in the Treatment of Advanced Solid Tumor
ClinicalTrials.gov ID: NCT07433283
What this study is testing
What is Carbon Nanoparticle-Loaded Iron [CNSI-Fe]?
Carbon Nanoparticle-Loaded Iron [CNSI-Fe] is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for tumor, solid.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Patients must meet all of the following criteria to be eligible:
- Understand and voluntarily sign the written informed consent form (ICF), be willing and able to comply with all trial requirements;
- Male or female aged 18\~80 years old (including cut-off value) at the time of signing the ICF;
- Stage Ib: patients with advanced solid tumors confirmed by histology or cytology, and the current standard therapy is ineffective (disease...
- At least one measurable lesion according to RESICT v1.1 and the lesion has not previously undergone radiotherapy (unless the lesion has clearly...
You likely can't join if
- Patients meeting any of the following criteria cannot participate in this clinical study:
- Previous or current diseases with abnormal iron metabolism (except for people with iron deficiency anemia), such as thalassemia, fava bean disease...
- Signs of perforation of hollow viscera at the previous or current injection site;
- Previous or current injection site with local skin breakdown, redness, swelling, necrosis, bleeding, etc., which affects the injection of study drugs;
- Systemic chemotherapy, targeted therapy, anti-tumor biologic therapy, or immunotherapy within 3 weeks prior to the first dose of study drug; Prior...
- Major surgery within 4 weeks prior to the first dose of study drug or unhealed wounds, ulcers, or fractures (except for minor surgeries performed...
See the full eligibility criteria
Who can join
- Patients must meet all of the following criteria to be eligible:
- Understand and voluntarily sign the written informed consent form (ICF), be willing and able to comply with all trial requirements;
- Male or female aged 18\~80 years old (including cut-off value) at the time of signing the ICF;
- 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...
- At least one measurable lesion according to RESICT v1.1 and the lesion has not previously undergone radiotherapy (unless the lesion has clearly progressed after radiotherapy) and has not undergone a tissue biopsy within...
- Have injectable lesions (such as direct injection or assisted injection by medical imaging instruments), which are judged by the investigator to be suitable for repeated intratumoral injection;
- The ECOG score within 7 days before the first dose is 0\~1 points;
- Expected survival ≥ 3 months;
- Adverse drug reactions (ADRs) caused by prior therapy have recovered to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 criteria grade 1 and below before screening...
- Left ventricular ejection fraction (LVEF) ≥50%;
- Within 7 days prior to the first dose, adequate hematologic and end-organ function with laboratory tests meeting the following criteria: haematology No treatment with granulocyte colony-stimulating factor (G-CSF) within...
- Female people of childbearing potential (WOCBP) who must have a negative serum pregnancy test result within 7 days prior to the first dose of study drug and a commitment to adequate and effective contraception or...
- Male people commit to adequate and effective contraception or abstinence during study drug treatment and for 6 months after the end of study drug treatment. In addition, male people must agree not to donate sperm during...
What rules you out
- Patients meeting any of the following criteria cannot participate in this clinical study:
- Previous or current diseases with abnormal iron metabolism (except for people with iron deficiency anemia), such as thalassemia, fava bean disease (erythrocyte glucose-6-phosphate dehydrogenase deficiency), etc.;
- Signs of perforation of hollow viscera at the previous or current injection site;
- Previous or current injection site with local skin breakdown, redness, swelling, necrosis, bleeding, etc., which affects the injection of study drugs;
- Systemic chemotherapy, targeted therapy, anti-tumor biologic therapy, or immunotherapy within 3 weeks prior to the first dose of study drug; Prior radiotherapy within 14 days prior to the first dose of study drug (with...
- Major surgery within 4 weeks prior to the first dose of study drug or unhealed wounds, ulcers, or fractures (except for minor surgeries performed within 1 week and full recovery);
- Untreated or with active brain metastases, spinal cord compression, carcinomatous meningitis, or other evidence that the subject's brain or spinal cord metastases have not been controlled (except for those who have been...
- Uncontrolled or poorly controlled hypertension (e.g., systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 100 mmHg);
- Uncontrolled tumor-related pain;
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage (once/month or more often);
- Active malignancy within 5 years prior to the first dose of study treatment, with the exception of non-melanoma skin cancer, localized prostate cancer, ductal carcinoma in situ or stage I uterine cancer, cervical...
- Vaccination with a live virus vaccine within 4 weeks prior to the first dose of study treatment; Note: Seasonal influenza vaccines for injection are usually inactivated influenza vaccines and are permitted; However...
- Those with a history of immunodeficiency, including human immunodeficiency virus (HIV) positive or other acquired, congenital immunodeficiency diseases, or a history of organ transplantation;
- Active hepatitis B virus (HBV) infection (HBV DNA quantification \>500 IU/mL), hepatitis C virus (HCV) infection (HCV antibody positive and polymerase chain reaction [PCR] of HCV ribonucleic acid [RNA] exceeds ULN)...
- Severe chronic or active infection (including tuberculosis infection, etc.) requiring systemic antibacterial, antifungal or antiviral therapy prior to the start of study treatment; Note: people with viral hepatitis are...
- History of severe cardiac insufficiency, stroke, or transient ischemic attack (TIA) within 6 months prior to enrollment. History of ventricular tachycardia or torsade de pointes. Any clinically important abnormalities...
- Have an active psychiatric disorder (schizophrenia, major depressive disorder, bipolar disorder, etc.);
- people who are known to be allergic or intolerant to the active ingredient or excipient of the study drug;
- Have participated in other treatment clinical studies within 3 weeks prior to the start of study treatment administration (calculated from the first day after the last dose of the previous study, except for those who...
- Other conditions judged by the investigator to be unsuitable for participation in this trial
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Hunan, Changsha, China
- Chongqing, Chongqing Municipality, China
- Fuzhou, Fujian, China
- Haikou, Hainan, China
- Heilongjiang, Harbin, China
- Shanghai, Shanghai Municipality, China
- Chengdu, Sichuan, China
- Henan, Zhengzhou, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Hunan, Changsha, China; Chongqing, Chongqing Municipality, China; Fuzhou, Fujian, China; Haikou, Hainan, China; Heilongjiang, Harbin, China and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.