{
    "info": {
        "nct_id": "NCT05380882",
        "official_title": "A Phase I Study of TQB2930 Injection in Patients With Advanced Cancers",
        "inclusion_criteria": "* 1 Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study;\n* 2 Male or female patient 18 to 75 years of age, an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1, and life expectancy ≥12 weeks;\n* 3 Histologically or cytologically confirmed, locally advanced tumors, Priority will be given to subjects with HER2 positive solid tumor;\n* 4 Malignant tumor that failed from standard treatment or had no standard treatment;\n* 5 According to the RECIST 1.1 standard, patient with at least one evaluable lesion;\n* 6 The main organs function well;\n* 7 Male or female patient had no plans to become pregnant and voluntarily took effective contraceptive measures from agree with the study to at least 6 months after the last dose of study drug.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
        "exclusion_criteria": "* 1 Concurrent secondary malignancy. or other malignancy with no evidence of disease for more than 3 years;\n* 2 History of uncontrolled intercurrent illness;\n* 3 Major surgical procedure, radiotherapy, chemotherapy, or immunotherapy within 4 weeks prior to first dose;\n* 4 Patients with known symptomatic brain metastases;\n* 5 Receiving any other investigational agent within 4 weeks before first dose;\n* 6 Unstable or serious concurrent medical conditions, as assessed by the Investigators, that would substantially increase the risk-benefit ratio of participating in the study.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* 1 Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study;",
            "criterions": [
                {
                    "exact_snippets": "Evidence of a personally signed and dated informed consent document",
                    "criterion": "informed consent document",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "indicating that the patient has been informed of all pertinent aspects of the study",
                    "criterion": "patient informed of study aspects",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 2 Male or female patient 18 to 75 years of age, an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1, and life expectancy ≥12 weeks;",
            "criterions": [
                {
                    "exact_snippets": "Male or female patient",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "18 to 75 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 75,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "life expectancy ≥12 weeks",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 3 Histologically or cytologically confirmed, locally advanced tumors, Priority will be given to subjects with HER2 positive solid tumor;",
            "criterions": [
                {
                    "exact_snippets": "Histologically or cytologically confirmed",
                    "criterion": "tumor confirmation method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "locally advanced tumors",
                    "criterion": "tumor stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "locally advanced"
                        }
                    ]
                },
                {
                    "exact_snippets": "HER2 positive solid tumor",
                    "criterion": "HER2 status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 4 Malignant tumor that failed from standard treatment or had no standard treatment;",
            "criterions": [
                {
                    "exact_snippets": "Malignant tumor",
                    "criterion": "malignant tumor",
                    "requirements": [
                        {
                            "requirement_type": "treatment response",
                            "expected_value": "failed from standard treatment or had no standard treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 5 According to the RECIST 1.1 standard, patient with at least one evaluable lesion;",
            "criterions": [
                {
                    "exact_snippets": "RECIST 1.1 standard, patient with at least one evaluable lesion",
                    "criterion": "evaluable lesion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "lesion"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 6 The main organs function well;",
            "criterions": [
                {
                    "exact_snippets": "main organs function well",
                    "criterion": "main organ function",
                    "requirements": [
                        {
                            "requirement_type": "functionality",
                            "expected_value": "well"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 7 Male or female patient had no plans to become pregnant and voluntarily took effective contraceptive measures from agree with the study to at least 6 months after the last dose of study drug.",
            "criterions": [
                {
                    "exact_snippets": "Male or female patient",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "no plans to become pregnant",
                    "criterion": "pregnancy plans",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "voluntarily took effective contraceptive measures",
                    "criterion": "contraceptive measures",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "from agree with the study to at least 6 months after the last dose of study drug",
                    "criterion": "duration of contraceptive measures",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "from agree with the study to at least 6 months after the last dose of study drug"
                        }
                    ]
                }
            ]
        },
        {
            "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"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 75 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 75 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 75,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* 1 Concurrent secondary malignancy. or other malignancy with no evidence of disease for more than 3 years;",
            "criterions": [
                {
                    "exact_snippets": "Concurrent secondary malignancy",
                    "criterion": "concurrent secondary malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "other malignancy with no evidence of disease for more than 3 years",
                    "criterion": "other malignancy",
                    "requirements": [
                        {
                            "requirement_type": "disease evidence",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "disease-free duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 2 History of uncontrolled intercurrent illness;",
            "criterions": [
                {
                    "exact_snippets": "History of uncontrolled intercurrent illness",
                    "criterion": "uncontrolled intercurrent illness",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 3 Major surgical procedure, radiotherapy, chemotherapy, or immunotherapy within 4 weeks prior to first dose;",
            "criterions": [
                {
                    "exact_snippets": "Major surgical procedure, radiotherapy, chemotherapy, or immunotherapy within 4 weeks prior to first dose",
                    "criterion": "major surgical procedure",
                    "requirements": [
                        {
                            "requirement_type": "time since procedure",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Major surgical procedure, radiotherapy, chemotherapy, or immunotherapy within 4 weeks prior to first dose",
                    "criterion": "radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Major surgical procedure, radiotherapy, chemotherapy, or immunotherapy within 4 weeks prior to first dose",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Major surgical procedure, radiotherapy, chemotherapy, or immunotherapy within 4 weeks prior to first dose",
                    "criterion": "immunotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 4 Patients with known symptomatic brain metastases;",
            "criterions": [
                {
                    "exact_snippets": "known symptomatic brain metastases",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "symptomatic",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "known",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 5 Receiving any other investigational agent within 4 weeks before first dose;",
            "criterions": [
                {
                    "exact_snippets": "Receiving any other investigational agent within 4 weeks before first dose",
                    "criterion": "investigational agent",
                    "requirements": [
                        {
                            "requirement_type": "time since last dose",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 6 Unstable or serious concurrent medical conditions, as assessed by the Investigators, that would substantially increase the risk-benefit ratio of participating in the study.",
            "criterions": [
                {
                    "exact_snippets": "Unstable or serious concurrent medical conditions",
                    "criterion": "concurrent medical conditions",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": [
                                "unstable",
                                "serious"
                            ]
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}