{
    "info": {
        "nct_id": "NCT06832982",
        "official_title": "A Single-arm, Open Phase I Clinical Trial Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacokinetics, and Preliminary Efficacy of FS-8002 in Patients With Advanced Solid Tumors",
        "inclusion_criteria": "1. Patients with advanced solid tumors confirmed by histology or cytology who have failed or become intolerant to previous standard treatments, or who do not have a standard treatment regimen；\n2. At least one measurable lesion according to the RECIST V1.1 assessment criteria ；\n3. The subject has sufficient organ and bone marrow function；\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Patients who have previously received TGF-β inhibitor therapy；\n2. Have received any experimental drug treatment within 4 weeks prior to the first administration of the investigational drug；\n3. Have used any systemic anti-tumor therapy within 4 weeks or 5 half-lives (whichever is shorter) before the first administration of the study drug, including systemic chemotherapy, radiotherapy, immunotherapy, hormone therapy, targeted therapy (small molecule targeted drugs are within 2 weeks before the first administration), systemic immunomodulators (including but not limited to IFN, IL-2 and tumor necrosis factor [TNF]). Received Chinese herbal or proprietary Chinese medicines with anti-tumor effects within 2 weeks before the first administration;\n4. Have used or are currently using aspirin (≥ 325 mg/day) or other anti-platelet aggregation drugs such as clopidogrel, dipyridamole, ticlopidine, and cilostazole, or full-dose anticoagulants or thrombolytics within 2 weeks prior to the first administration of the study drug;\n5. Those who have received major surgical treatment or significant traumatic injury within 4 weeks before the first administration of the study drug, or those who have a history of fistula, gastrointestinal perforation, or tumor invasion of large blood vessels within 6 months before the first administration; or those who have intestinal obstruction during the screening period;",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Patients with advanced solid tumors confirmed by histology or cytology who have failed or become intolerant to previous standard treatments, or who do not have a standard treatment regimen；",
            "criterions": [
                {
                    "exact_snippets": "advanced solid tumors confirmed by histology or cytology",
                    "criterion": "solid tumors",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "advanced"
                        },
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histology",
                                "cytology"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "failed or become intolerant to previous standard treatments",
                    "criterion": "response to previous standard treatments",
                    "requirements": [
                        {
                            "requirement_type": "response",
                            "expected_value": [
                                "failed",
                                "intolerant"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "do not have a standard treatment regimen",
                    "criterion": "availability of standard treatment regimen",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. At least one measurable lesion according to the RECIST V1.1 assessment criteria ；",
            "criterions": [
                {
                    "exact_snippets": "At least one measurable lesion according to the RECIST V1.1 assessment criteria",
                    "criterion": "measurable lesion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        },
                        {
                            "requirement_type": "assessment criteria",
                            "expected_value": "RECIST V1.1"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. The subject has sufficient organ and bone marrow function；",
            "criterions": [
                {
                    "exact_snippets": "sufficient organ and bone marrow function",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "sufficiency",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "sufficient organ and bone marrow function",
                    "criterion": "bone marrow function",
                    "requirements": [
                        {
                            "requirement_type": "sufficiency",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Patients who have previously received TGF-β inhibitor therapy；",
            "criterions": [
                {
                    "exact_snippets": "Patients who have previously received TGF-β inhibitor therapy",
                    "criterion": "TGF-β inhibitor therapy",
                    "requirements": [
                        {
                            "requirement_type": "previous treatment",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Have received any experimental drug treatment within 4 weeks prior to the first administration of the investigational drug；",
            "criterions": [
                {
                    "exact_snippets": "Have received any experimental drug treatment within 4 weeks prior to the first administration of the investigational drug",
                    "criterion": "experimental drug treatment",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Have used any systemic anti-tumor therapy within 4 weeks or 5 half-lives (whichever is shorter) before the first administration of the study drug, including systemic chemotherapy, radiotherapy, immunotherapy, hormone therapy, targeted therapy (small molecule targeted drugs are within 2 weeks before the first administration), systemic immunomodulators (including but not limited to IFN, IL-2 and tumor necrosis factor [TNF]). Received Chinese herbal or proprietary Chinese medicines with anti-tumor effects within 2 weeks before the first administration;",
            "criterions": [
                {
                    "exact_snippets": "Have used any systemic anti-tumor therapy within 4 weeks or 5 half-lives (whichever is shorter) before the first administration of the study drug",
                    "criterion": "systemic anti-tumor therapy",
                    "requirements": [
                        {
                            "requirement_type": "usage",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "systemic chemotherapy",
                    "criterion": "systemic chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "usage",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "radiotherapy",
                    "criterion": "radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "usage",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "immunotherapy",
                    "criterion": "immunotherapy",
                    "requirements": [
                        {
                            "requirement_type": "usage",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "hormone therapy",
                    "criterion": "hormone therapy",
                    "requirements": [
                        {
                            "requirement_type": "usage",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "targeted therapy (small molecule targeted drugs are within 2 weeks before the first administration)",
                    "criterion": "targeted therapy",
                    "requirements": [
                        {
                            "requirement_type": "usage",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "systemic immunomodulators (including but not limited to IFN, IL-2 and tumor necrosis factor [TNF])",
                    "criterion": "systemic immunomodulators",
                    "requirements": [
                        {
                            "requirement_type": "usage",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Received Chinese herbal or proprietary Chinese medicines with anti-tumor effects within 2 weeks before the first administration",
                    "criterion": "Chinese herbal or proprietary Chinese medicines with anti-tumor effects",
                    "requirements": [
                        {
                            "requirement_type": "usage",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Have used or are currently using aspirin (≥ 325 mg/day) or other anti-platelet aggregation drugs such as clopidogrel, dipyridamole, ticlopidine, and cilostazole, or full-dose anticoagulants or thrombolytics within 2 weeks prior to the first administration of the study drug;",
            "criterions": [
                {
                    "exact_snippets": "Have used or are currently using aspirin (≥ 325 mg/day)",
                    "criterion": "aspirin usage",
                    "requirements": [
                        {
                            "requirement_type": "dosage",
                            "expected_value": {
                                "operator": ">=",
                                "value": 325,
                                "unit": "mg/day"
                            }
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 2 weeks prior to the first administration of the study drug"
                        }
                    ]
                },
                {
                    "exact_snippets": "Have used or are currently using ... anti-platelet aggregation drugs such as clopidogrel, dipyridamole, ticlopidine, and cilostazole",
                    "criterion": "anti-platelet aggregation drug usage",
                    "requirements": [
                        {
                            "requirement_type": "drug types",
                            "expected_value": [
                                "clopidogrel",
                                "dipyridamole",
                                "ticlopidine",
                                "cilostazole"
                            ]
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 2 weeks prior to the first administration of the study drug"
                        }
                    ]
                },
                {
                    "exact_snippets": "Have used or are currently using ... full-dose anticoagulants or thrombolytics",
                    "criterion": "full-dose anticoagulant or thrombolytic usage",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 2 weeks prior to the first administration of the study drug"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Those who have received major surgical treatment or significant traumatic injury within 4 weeks before the first administration of the study drug, or those who have a history of fistula, gastrointestinal perforation, or tumor invasion of large blood vessels within 6 months before the first administration; or those who have intestinal obstruction during the screening period;",
            "criterions": [
                {
                    "exact_snippets": "received major surgical treatment ... within 4 weeks before the first administration of the study drug",
                    "criterion": "major surgical treatment",
                    "requirements": [
                        {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "significant traumatic injury within 4 weeks before the first administration of the study drug",
                    "criterion": "significant traumatic injury",
                    "requirements": [
                        {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "history of fistula ... within 6 months before the first administration",
                    "criterion": "history of fistula",
                    "requirements": [
                        {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": "<",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "history of ... gastrointestinal perforation ... within 6 months before the first administration",
                    "criterion": "history of gastrointestinal perforation",
                    "requirements": [
                        {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": "<",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "history of ... tumor invasion of large blood vessels within 6 months before the first administration",
                    "criterion": "history of tumor invasion of large blood vessels",
                    "requirements": [
                        {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": "<",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "intestinal obstruction during the screening period",
                    "criterion": "intestinal obstruction",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}