{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"91.22","value":"2869.50"},{"groupId":"OG001","spread":"7915.82","value":"7485.00"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"3"}],"units":"Participants"}],"description":"This secondary outcome measure focuses on assessing the pharmacokinetic (PK) profile of CNSI-Fe(II) in patients with advanced solid tumors.\n\nAssessment Details:\n\nPK Parameters Assessment: This assessment involves the analysis of the drug's absorption, distribution, metabolism, and excretion (ADME) in patients. It will provide insights into how CNSI-Fe(II) behaves in the human body. The fifth assessed parameter is serum iron concentration.\n\nSerum iron concentration at 15 min of first dosage: The number of patients receiving the second dose in the 30 mg, 60 mg, 90 mg, 120 mg, and 150 mg dose groups was: 1, 2, 3, 1, and 0, respectively. Due to the requirement for mean ± SD data presentation, the number of evaluable subjects in 30 mg, 120 mg, 150 mg groups was fewer than two, making SD calculation impossible.\n\nUnits of Measure:\n\nNanograms per milliliter (ng/mL) (serum iron ion concentrations changes from baseline)","dispersionType":"Standard Deviation","groups":[{"description":"60 mg\n\nCNSI-Fe(II) 60 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.","id":"OG000","title":"CNSI-Fe(II) 60 mg"},{"description":"90 mg\n\nCNSI-Fe(II) 90 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.","id":"OG001","title":"CNSI-Fe(II) 90 mg"}],"paramType":"MEAN","populationDescription":"The number of patients receiving the second dose in the 30 mg, 60 mg, 90 mg, 120 mg, and 150 mg dose groups was: 1, 2, 3, 1, and 0, respectively.","reportingStatus":"POSTED","timeFrame":"at 15 min (of a time frame of 72 h) of second dosage (22~35 days after first dosing. For patient in 30 mg group, 23 days; for patients in 60 mg group, 26 and 22 days; for patients in 90 mg group, 23, 35 and 28 days; for patient in 120 mg group, 28 days.)","title":"PK Parameters Assessment: Serum Iron Concentration at 15 Min of Second Dosage","type":"SECONDARY","unitOfMeasure":"concentration (ng/mL)"}