Carbon Nanoparticle-Loaded Iron in the Treatment of Advanced Solid Tumor (NCT07433283) | Clinical Trial Compass
RecruitingPhase 1/2
Carbon Nanoparticle-Loaded Iron in the Treatment of Advanced Solid Tumor
China54 participantsStarted 2024-11-12
Plain-language summary
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.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. 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 effective standard treatment, such as soft tissue sarcoma, refractory thyroid cancer, colorectal cancer, pancreatic cancer, breast cancer, gastric cancer, cervical cancer, lung cancer, head and neck cancer, liver cancer, bile duct cancer, kidney cancer, prostate cancer, vulvar cancer, etc.; Note: Subjects with advanced solid tumors whose disease progresses due to no standard therapy for any reason, or advanced solid tumors whose disease has progressed after receiving the first course of standard therapy for tumor types that are not sensitive to existing standard therapies (e.g., pancreatic cancer, undifferentiated thyroid cancer, sarcoma, etc.) can be included.
✓. 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 7 days prior to screening;
✓. 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;
What they're measuring
1
Incidence and severity of participants with treatment-related adverse events as assessed by CTCAE v5.0
Timeframe: From enrollment to the end of treatment at 12 weeks
Trial details
NCT IDNCT07433283
SponsorSichuan Enray Pharmaceutical Sciences Company
✓. 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 (alopecia, grade 2 or below peripheral neurotoxicity, etc., except for toxicities judged by the investigator to be of low safety risk);
Exclusion criteria
✕. Previous or current diseases with abnormal iron metabolism (except for subjects 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 the exception of central nervous system \[CNS\] radiotherapy, which requires a washout period of ≥ 28 days); Received traditional Chinese medicine with anti-tumor indications within 2 weeks before the first dose of the study drug;
✕. 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 treated and have stable symptoms, have been stable for at least 4 weeks before the first dose on imaging tests, and have no evidence of cerebral edema, and do not require glucocorticoid therapy);
✕. Uncontrolled or poorly controlled hypertension (e.g., systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 100 mmHg);