{
    "info": {
        "nct_id": "NCT05048160",
        "official_title": "Phase I/II Clinical Trial of 6MW3211 Injection to Evaluate Safety, Tolerability, PK/PD, Immunogenicity and Preliminary Efficacy in Subjects With Advanced Malignant Neoplasm.(Only Phase I Has Been Submitted to US FDA)",
        "inclusion_criteria": "* 1. Men or women, age ≥18.\n* 2.Subjects with advanced malignancy histopathologically and/or cytologically, with at least one evaluable tumor lesion.\n* 3.ECOG PS is 0 or 1.\n* 4.Survival expectation of at least 3 months.\n* 5.Adequate organs and hematopoietic functions\n* 6.Voluntarily signing of informed consent\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* 1.Subjects with brain metastases of clinically active central nervous system (CNS).\n* 2.Subjects that require to take anticoagulants and/or aspirin.\n* 3.Blood transfusion within 2 weeks prior to the first administration of study treatment.\n* 4.Inadequately controlled body cavity effusions.\n* 5.Subjects with active, or have a history and possible recurrence of autoimmune diseases .\n* 6.Have uncontrolled systemic diseases.\n* 7.Subjects who had received anticancer therapy or radiotherapy within 4 weeks or 5 half-lives (whichever is shorter) before enrollment.\n* 8.Subjects are known to have previously experienced severe allergic reactions to large molecular protein formulations/monoclonal antibodies.\n* 9.Pregnant or lactating women.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* 1. Men or women, age ≥18.",
            "criterions": [
                {
                    "exact_snippets": "Men or women",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "age ≥18",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 2.Subjects with advanced malignancy histopathologically and/or cytologically, with at least one evaluable tumor lesion.",
            "criterions": [
                {
                    "exact_snippets": "advanced malignancy histopathologically and/or cytologically",
                    "criterion": "advanced malignancy",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histopathologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "at least one evaluable tumor lesion",
                    "criterion": "evaluable tumor lesion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "lesion"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 3.ECOG PS is 0 or 1.",
            "criterions": [
                {
                    "exact_snippets": "ECOG PS is 0 or 1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 4.Survival expectation of at least 3 months.",
            "criterions": [
                {
                    "exact_snippets": "Survival expectation of at least 3 months.",
                    "criterion": "survival expectation",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 5.Adequate organs and hematopoietic functions",
            "criterions": [
                {
                    "exact_snippets": "Adequate organs",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hematopoietic functions",
                    "criterion": "hematopoietic function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 6.Voluntarily signing of informed consent",
            "criterions": [
                {
                    "exact_snippets": "Voluntarily signing of informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "voluntariness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "signing",
                            "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.Subjects with brain metastases of clinically active central nervous system (CNS).",
            "criterions": [
                {
                    "exact_snippets": "brain metastases",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "clinically active central nervous system (CNS)",
                    "criterion": "clinically active CNS",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "active"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 2.Subjects that require to take anticoagulants and/or aspirin.",
            "criterions": [
                {
                    "exact_snippets": "Subjects that require to take anticoagulants",
                    "criterion": "anticoagulant requirement",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Subjects that require to take ... aspirin",
                    "criterion": "aspirin requirement",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 3.Blood transfusion within 2 weeks prior to the first administration of study treatment.",
            "criterions": [
                {
                    "exact_snippets": "Blood transfusion within 2 weeks prior to the first administration of study treatment.",
                    "criterion": "blood transfusion",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 2 weeks prior to the first administration of study treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 4.Inadequately controlled body cavity effusions.",
            "criterions": [
                {
                    "exact_snippets": "Inadequately controlled body cavity effusions",
                    "criterion": "body cavity effusions",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 5.Subjects with active, or have a history and possible recurrence of autoimmune diseases .",
            "criterions": [
                {
                    "exact_snippets": "active, or have a history and possible recurrence of autoimmune diseases",
                    "criterion": "autoimmune diseases",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "active",
                                "history",
                                "possible recurrence"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 6.Have uncontrolled systemic diseases.",
            "criterions": [
                {
                    "exact_snippets": "uncontrolled systemic diseases",
                    "criterion": "systemic diseases",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 7.Subjects who had received anticancer therapy or radiotherapy within 4 weeks or 5 half-lives (whichever is shorter) before enrollment.",
            "criterions": [
                {
                    "exact_snippets": "Subjects who had received anticancer therapy ... within 4 weeks or 5 half-lives (whichever is shorter) before enrollment.",
                    "criterion": "anticancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Subjects who had received ... radiotherapy within 4 weeks or 5 half-lives (whichever is shorter) before enrollment.",
                    "criterion": "radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 8.Subjects are known to have previously experienced severe allergic reactions to large molecular protein formulations/monoclonal antibodies.",
            "criterions": [
                {
                    "exact_snippets": "previously experienced severe allergic reactions to large molecular protein formulations/monoclonal antibodies",
                    "criterion": "allergic reactions to large molecular protein formulations/monoclonal antibodies",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 9.Pregnant or lactating women.",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "lactating women",
                    "criterion": "lactation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}