{
    "info": {
        "nct_id": "NCT03398720",
        "official_title": "A Two-Part, Phase 1, Open-Label, Multicenter, Non-Randomized, Dose Escalation/Expansion Study to Evaluate the Safety and Tolerability of HTI-1066 in Subjects With Advanced Solid Tumors",
        "inclusion_criteria": "1. Male or female ≥18 years of age\n2. Subject must have an advanced solid tumor\n3. ECOG Performance Status of 0 or 1\n4. Life expectancy ≥12 weeks\n5. Adequate laboratory parameters\n6. Female subjects agree not to be pregnant or lactating from beginning of the study screening until 4 months after receiving the last treatment; Male and female subjects and their sexual partners are willing and able to employ a highly effective method of birth control/contraception.\n7. Willing and able to comply with clinic visits and study-related procedures\n8. Provide signed informed consent\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Hypersensitivity to HTI-1066 or sensitivity to humanized monoclonal antibody products\n2. Any concurrent therapy for cancer, radiation, or surgery within 4 weeks, except for minor palliative intent (this is to be discussed with sponsor)\n3. Any concurrent use of anti-infective, anti-fungal, or anti-viral agent (exceptions are to be approved by the sponsor)\n4. Any other prohibited or restricted medication as described in the study protocol.\n5. Investigational therapy administered <5 half-lives before the first dose of HTI-1066\n6. Any anticancer therapy administered <5 half-lives before first dose of HTI-1066; any prior immune-oncology products administered within 4 weeks or 5 half-lives before the first dose of HTI-1066 as described above; or surgery or radiotherapy administered within 4 weeks before the first dose of HTI-1066.\n7. Active CNS metastases.\n8. Cardiac disease (NYHA classes II-IV) including myocardial infarction within 6 months before enrollment, or unstable angina, congestive heart failure, or cardiac arrhythmia requiring treatment.\n9. History or presence of an abnormal ECG, ECHO, or MUGA that is clinically meaningful.\n10. History of immunodeficiency including seropositivity for human immunodeficiency virus (HIV), or other acquired or congenital immune-deficient disease, or any active systemic viral infection requiring therapy (e.g., hepatitis B or C)\n11. Any other medical, psychiatric, or social condition deemed by the investigator to be likely to interfere with a subject's rights, safety, welfare or ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results\n12. Active infection or an unexplained fever >38.5°C during Screening or on the first scheduled day of dosing.\n13. Unresolved toxicities from previous anticancer therapy.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "2. Subject must have an advanced solid tumor",
                "criterions": [
                    {
                        "exact_snippets": "Subject must have an advanced solid tumor",
                        "criterion": "solid tumor",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": "advanced"
                        }
                    }
                ]
            },
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                "and_criteria": [
                    {
                        "exact_snippets": "Subject must have an advanced solid tumor",
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                            "expected_value": "advanced"
                        }
                    }
                ]
            }
        },
        {
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                "line": "3. ECOG Performance Status of 0 or 1",
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                    {
                        "exact_snippets": "ECOG Performance Status of 0 or 1",
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                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "ECOG Performance Status of 0 or 1",
                        "criterion": "ECOG Performance Status",
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                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "4. Life expectancy ≥12 weeks",
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                    {
                        "exact_snippets": "Life expectancy ≥12 weeks",
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                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
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                    {
                        "exact_snippets": "Life expectancy ≥12 weeks",
                        "criterion": "life expectancy",
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                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            }
        },
        {
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                "line": "5. Adequate laboratory parameters",
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                    {
                        "exact_snippets": "Adequate laboratory parameters",
                        "criterion": "laboratory parameters",
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                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    }
                ]
            },
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                    {
                        "exact_snippets": "Adequate laboratory parameters",
                        "criterion": "laboratory parameters",
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                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "6. Female subjects agree not to be pregnant or lactating from beginning of the study screening until 4 months after receiving the last treatment; Male and female subjects and their sexual partners are willing and able to employ a highly effective method of birth control/contraception.",
                "criterions": [
                    {
                        "exact_snippets": "Female subjects agree not to be pregnant",
                        "criterion": "pregnancy",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Female subjects agree not to be ... lactating",
                        "criterion": "lactation",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Male and female subjects and their sexual partners are willing and able to employ a highly effective method of birth control/contraception",
                        "criterion": "birth control/contraception",
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                            "expected_value": true
                        }
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                ]
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                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Female subjects agree not to be pregnant",
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                                        "requirement": {
                                            "requirement_type": "status",
                                            "expected_value": false
                                        }
                                    },
                                    {
                                        "exact_snippets": "Female subjects agree not to be ... lactating",
                                        "criterion": "lactation",
                                        "requirement": {
                                            "requirement_type": "status",
                                            "expected_value": false
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "Male and female subjects and their sexual partners are willing and able to employ a highly effective method of birth control/contraception",
                                "criterion": "birth control/contraception",
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                                    "requirement_type": "willingness and ability",
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                                }
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                ]
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        },
        {
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                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Willing and able to comply with clinic visits",
                        "criterion": "compliance with clinic visits",
                        "requirement": {
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                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Willing and able to comply with ... study-related procedures",
                        "criterion": "compliance with study-related procedures",
                        "requirement": {
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                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Willing and able to comply with ... study-related procedures",
                        "criterion": "compliance with study-related procedures",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Willing and able to comply with clinic visits",
                                "criterion": "compliance with clinic visits",
                                "requirement": {
                                    "requirement_type": "willingness",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "Willing and able to comply with clinic visits",
                                "criterion": "compliance with clinic visits",
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                                    "requirement_type": "ability",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Willing and able to comply with ... study-related procedures",
                                "criterion": "compliance with study-related procedures",
                                "requirement": {
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                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "Willing and able to comply with ... study-related procedures",
                                "criterion": "compliance with study-related procedures",
                                "requirement": {
                                    "requirement_type": "ability",
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                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
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                "line": "8. Provide signed informed consent",
                "criterions": [
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                        "exact_snippets": "Provide signed informed consent",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Provide signed informed consent",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Healthy volunteers allowed",
                "criterions": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            },
            "logical_structure": {
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                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
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                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have minimum age of 18 Years",
                "criterions": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
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                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "1. Hypersensitivity to HTI-1066 or sensitivity to humanized monoclonal antibody products",
                "criterions": [
                    {
                        "exact_snippets": "Hypersensitivity to HTI-1066",
                        "criterion": "hypersensitivity to HTI-1066",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "sensitivity to humanized monoclonal antibody products",
                        "criterion": "sensitivity to humanized monoclonal antibody products",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
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                    {
                        "exact_snippets": "Hypersensitivity to HTI-1066",
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                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "sensitivity to humanized monoclonal antibody products",
                        "criterion": "sensitivity to humanized monoclonal antibody products",
                        "requirement": {
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                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "2. Any concurrent therapy for cancer, radiation, or surgery within 4 weeks, except for minor palliative intent (this is to be discussed with sponsor)",
                "criterions": [
                    {
                        "exact_snippets": "Any concurrent therapy for cancer",
                        "criterion": "concurrent therapy for cancer",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "radiation, or surgery within 4 weeks",
                        "criterion": "radiation or surgery",
                        "requirement": {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
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                            "exact_snippets": "Any concurrent therapy for cancer",
                            "criterion": "concurrent therapy for cancer",
                            "requirement": {
                                "requirement_type": "presence",
                                "expected_value": false
                            }
                        }
                    },
                    {
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                                "exact_snippets": "radiation, or surgery within 4 weeks",
                                "criterion": "radiation or surgery",
                                "requirement": {
                                    "requirement_type": "time since last treatment",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                }
                            },
                            {
                                "not_criteria": {
                                    "exact_snippets": "except for minor palliative intent (this is to be discussed with sponsor)",
                                    "criterion": "minor palliative intent",
                                    "requirement": {
                                        "requirement_type": "exception",
                                        "expected_value": true
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "identified_line": {
                "line": "1. Male or female ≥18 years of age",
                "criterions": [
                    {
                        "exact_snippets": "Male or female",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "≥18 years of age",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
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                        "or_criteria": [
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                                "exact_snippets": "Male or female",
                                "criterion": "gender",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": "male"
                                }
                            },
                            {
                                "exact_snippets": "Male or female",
                                "criterion": "gender",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": "female"
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "≥18 years of age",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "failed_exclusion": [
        {
            "identified_line": {
                "line": "4. Any other prohibited or restricted medication as described in the study protocol.",
                "criterions": [
                    {
                        "exact_snippets": "Any other prohibited or restricted medication",
                        "criterion": "medication",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": [
                                "prohibited",
                                "restricted"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
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                }
            }
        },
        {
            "identified_line": {
                "line": "5. Investigational therapy administered <5 half-lives before the first dose of HTI-1066",
                "criterions": [
                    {
                        "exact_snippets": "Investigational therapy administered <5 half-lives before the first dose of HTI-1066",
                        "criterion": "investigational therapy",
                        "requirement": {
                            "requirement_type": "administration timing",
                            "expected_value": {
                                "operator": "<",
                                "value": 5,
                                "unit": "half-lives"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "6. Any anticancer therapy administered <5 half-lives before first dose of HTI-1066; any prior immune-oncology products administered within 4 weeks or 5 half-lives before the first dose of HTI-1066 as described above; or surgery or radiotherapy administered within 4 weeks before the first dose of HTI-1066.",
                "criterions": [
                    {
                        "exact_snippets": "Any anticancer therapy administered <5 half-lives before first dose of HTI-1066",
                        "criterion": "anticancer therapy",
                        "requirement": {
                            "requirement_type": "time since administration",
                            "expected_value": {
                                "operator": "<",
                                "value": 5,
                                "unit": "half-lives"
                            }
                        }
                    },
                    {
                        "exact_snippets": "any prior immune-oncology products administered within 4 weeks or 5 half-lives before the first dose of HTI-1066",
                        "criterion": "prior immune-oncology products",
                        "requirement": {
                            "requirement_type": "time since administration",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "weeks"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "half-lives"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "surgery or radiotherapy administered within 4 weeks before the first dose of HTI-1066",
                        "criterion": "surgery or radiotherapy",
                        "requirement": {
                            "requirement_type": "time since administration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
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            }
        },
        {
            "identified_line": {
                "line": "7. Active CNS metastases.",
                "criterions": [
                    {
                        "exact_snippets": "Active CNS metastases",
                        "criterion": "CNS metastases",
                        "requirement": {
                            "requirement_type": "activity",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "8. Cardiac disease (NYHA classes II-IV) including myocardial infarction within 6 months before enrollment, or unstable angina, congestive heart failure, or cardiac arrhythmia requiring treatment.",
                "criterions": [
                    {
                        "exact_snippets": "Cardiac disease (NYHA classes II-IV)",
                        "criterion": "cardiac disease",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": [
                                "NYHA class II",
                                "NYHA class III",
                                "NYHA class IV"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "myocardial infarction within 6 months before enrollment",
                        "criterion": "myocardial infarction",
                        "requirement": {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    },
                    {
                        "exact_snippets": "unstable angina",
                        "criterion": "unstable angina",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "congestive heart failure",
                        "criterion": "congestive heart failure",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "cardiac arrhythmia requiring treatment",
                        "criterion": "cardiac arrhythmia",
                        "requirement": {
                            "requirement_type": "treatment requirement",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
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                }
            }
        },
        {
            "identified_line": {
                "line": "9. History or presence of an abnormal ECG, ECHO, or MUGA that is clinically meaningful.",
                "criterions": [
                    {
                        "exact_snippets": "History or presence of an abnormal ECG",
                        "criterion": "ECG",
                        "requirement": {
                            "requirement_type": "abnormality",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "History or presence of an abnormal ECG",
                        "criterion": "ECG",
                        "requirement": {
                            "requirement_type": "clinical significance",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "History or presence of an abnormal ... ECHO",
                        "criterion": "ECHO",
                        "requirement": {
                            "requirement_type": "abnormality",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "History or presence of an abnormal ... ECHO",
                        "criterion": "ECHO",
                        "requirement": {
                            "requirement_type": "clinical significance",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "History or presence of an abnormal ... MUGA",
                        "criterion": "MUGA",
                        "requirement": {
                            "requirement_type": "abnormality",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "History or presence of an abnormal ... MUGA",
                        "criterion": "MUGA",
                        "requirement": {
                            "requirement_type": "clinical significance",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "10. History of immunodeficiency including seropositivity for human immunodeficiency virus (HIV), or other acquired or congenital immune-deficient disease, or any active systemic viral infection requiring therapy (e.g., hepatitis B or C)",
                "criterions": [
                    {
                        "exact_snippets": "History of immunodeficiency",
                        "criterion": "immunodeficiency",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "seropositivity for human immunodeficiency virus (HIV)",
                        "criterion": "HIV seropositivity",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "acquired or congenital immune-deficient disease",
                        "criterion": "immune-deficient disease",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": [
                                "acquired",
                                "congenital"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "active systemic viral infection requiring therapy",
                        "criterion": "systemic viral infection",
                        "requirement": {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    },
                    {
                        "exact_snippets": "active systemic viral infection requiring therapy",
                        "criterion": "systemic viral infection",
                        "requirement": {
                            "requirement_type": "treatment",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "hepatitis B or C",
                        "criterion": "hepatitis B or C",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "11. Any other medical, psychiatric, or social condition deemed by the investigator to be likely to interfere with a subject's rights, safety, welfare or ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results",
                "criterions": [
                    {
                        "exact_snippets": "Any other medical, psychiatric, or social condition",
                        "criterion": "medical, psychiatric, or social condition",
                        "requirement": {
                            "requirement_type": "interference with study",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "12. Active infection or an unexplained fever >38.5°C during Screening or on the first scheduled day of dosing.",
                "criterions": [
                    {
                        "exact_snippets": "Active infection",
                        "criterion": "infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "unexplained fever >38.5°C",
                        "criterion": "fever",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 38.5,
                                "unit": "°C"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "13. Unresolved toxicities from previous anticancer therapy.",
                "criterions": [
                    {
                        "exact_snippets": "Unresolved toxicities from previous anticancer therapy",
                        "criterion": "toxicities from previous anticancer therapy",
                        "requirement": {
                            "requirement_type": "resolution",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "3. Any concurrent use of anti-infective, anti-fungal, or anti-viral agent (exceptions are to be approved by the sponsor)",
                "criterions": [
                    {
                        "exact_snippets": "concurrent use of anti-infective",
                        "criterion": "concurrent use of anti-infective agent",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "concurrent use of anti-fungal",
                        "criterion": "concurrent use of anti-fungal agent",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "concurrent use of anti-viral agent",
                        "criterion": "concurrent use of anti-viral agent",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        }
    ],
    "failed_miscellaneous": []
}