{
    "info": {
        "nct_id": "NCT06652529",
        "official_title": "First in Human Phase 1 Dose Escalation and Expansion Clinical Trial to Evaluate the Safety, Pharmacokinetics and Antitumor Activity of Intravenous AROG4-01 in Patients With Advanced Solid Tumors",
        "inclusion_criteria": "1. Male or female patients, 18 years or older, with a diagnosis (histology or citology) of advanced (unresectable or metastatic) solid tumor for which there is no curative therapy, has progressed on SOC treatment or for whom SOC is no longer an option. In part B patients will be included in different cohorts according to the histology (mesothelioma vs. non-mesothelioma).\n2. Evaluable (part A) or measurable disease (part B) as per RECIST v1.1 (part A) or mRECIST v1.1. (part B). Progressive disease to the on or following the last line of antitumor treatment.\n3. ECOG performance status ≤ 2.\n4. Life expectancy ≥12 weeks.\n5. Hematology and clinical chemistry laboratory parameters within acceptable ranges.\n6. Adequate organ function as defined below:\n\n   * Hemoglobin ≥9 g/dL\n   * Neutrophil count ≥1.000x10/mcL\n   * Platelets ≥100.000/mcL\n   * Total bilirubin ≤1,5 x Upper Limit of Normal (ULN) (unless Gilbert's Disease)\n   * AST (SGOT)/ALT (SGPT) ≤ 2,5 x institutional ULN (or ≤ 5X ULN in the presence of liver metastases)\n   * Creatinine ≤1.5 mg/dL and creatinine CL ≥40 mL/min (calculated using the Cockcroft-Gault formula)\n7. Adequate coagulation profile as defined below:\n\n   * INR≤ 1,5\n   * aPTT ≤ 1,5 x ULN\n   * Serum or urine negative pregnancy test for women with childbearing potential.\n8. No previous antitumor treatment (radiation therapy, systemic treatment, or surgery) in the previous 28 days and current adverse events from them ≤ grade 1.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Systemic anti-cancer therapy within 4 weeks prior to study admission.\n2. Radiation therapy within 4 weeks prior to study entry.\n3. Any major surgery within 4 weeks before first dose of study treatment No major surgery must be planned during the trial expected treatment. receiving study treatment. Participants with recent surgery with only local anesthesia may be included.\n4. Non-malignant systemic disease including cerebrovascular accident, myocardial infarction in the last 6 months, unstable angina pectoris, unstable cardiac arrhythmia, New York Heart Association (NYHA) Class III or IV heart failure, coagulation abnormalities and clinically significant pulmonary compromise, .\n5. Left ventricular ejection fraction below institutional normal limits.\n6. Patients with symptomatic central nervous system (CNS) primary tumor or metastases (including leptomeningeal carcinomatosis). Patients with documented treated CNS metastases stable for at least 4 weeks may be enrolled at the discretion of the investigator.\n7. Breast feeding, pregnancy or not willing to adopt safe contraceptive measures by the patient or the patient's partner, to become pregnant during treatment or within 6 months after the end of treatment.\n8. Patients with active uncontrolled infection or known to be serologically positive for human immunodeficiency virus (HIV), hepatitis B (except HbsAc after vaccination) or hepatitis C infection.\n9. Any other diseases or medical condition that may interfere with the planned treatment, compliance, or place the patient at risk if participating in the study, at investigator criteria.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "1. Male or female patients, 18 years or older, with a diagnosis (histology or citology) of advanced (unresectable or metastatic) solid tumor for which there is no curative therapy, has progressed on SOC treatment or for whom SOC is no longer an option. In part B patients will be included in different cohorts according to the histology (mesothelioma vs. non-mesothelioma).",
                "criterions": [
                    {
                        "exact_snippets": "Male or female patients",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "18 years or older",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    },
                    {
                        "exact_snippets": "diagnosis (histology or citology) of advanced (unresectable or metastatic) solid tumor",
                        "criterion": "diagnosis of advanced solid tumor",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "for which there is no curative therapy",
                        "criterion": "curative therapy availability",
                        "requirement": {
                            "requirement_type": "availability",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "has progressed on SOC treatment",
                        "criterion": "progression on SOC treatment",
                        "requirement": {
                            "requirement_type": "progression",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "for whom SOC is no longer an option",
                        "criterion": "SOC treatment option",
                        "requirement": {
                            "requirement_type": "availability",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "In part B patients will be included in different cohorts according to the histology (mesothelioma vs. non-mesothelioma)",
                        "criterion": "histology for cohort inclusion",
                        "requirement": {
                            "requirement_type": "categorization",
                            "expected_value": [
                                "mesothelioma",
                                "non-mesothelioma"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "Male or female patients",
                                "criterion": "gender",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": [
                                        "male",
                                        "female"
                                    ]
                                }
                            },
                            {
                                "exact_snippets": "18 years or older",
                                "criterion": "age",
                                "requirement": {
                                    "requirement_type": "minimum age",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "diagnosis (histology or citology) of advanced (unresectable or metastatic) solid tumor",
                        "criterion": "diagnosis of advanced solid tumor",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "for which there is no curative therapy",
                                "criterion": "curative therapy availability",
                                "requirement": {
                                    "requirement_type": "availability",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "has progressed on SOC treatment",
                                "criterion": "progression on SOC treatment",
                                "requirement": {
                                    "requirement_type": "progression",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "for whom SOC is no longer an option",
                                "criterion": "SOC treatment option",
                                "requirement": {
                                    "requirement_type": "availability",
                                    "expected_value": false
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "In part B patients will be included in different cohorts according to the histology (mesothelioma vs. non-mesothelioma)",
                        "criterion": "histology for cohort inclusion",
                        "requirement": {
                            "requirement_type": "categorization",
                            "expected_value": [
                                "mesothelioma",
                                "non-mesothelioma"
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "4. Life expectancy ≥12 weeks.",
                "criterions": [
                    {
                        "exact_snippets": "Life expectancy ≥12 weeks.",
                        "criterion": "life expectancy",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Life expectancy ≥12 weeks.",
                        "criterion": "life expectancy",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "5. Hematology and clinical chemistry laboratory parameters within acceptable ranges.",
                "criterions": [
                    {
                        "exact_snippets": "Hematology ... laboratory parameters within acceptable ranges.",
                        "criterion": "hematology laboratory parameters",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": "acceptable ranges"
                        }
                    },
                    {
                        "exact_snippets": "clinical chemistry laboratory parameters within acceptable ranges.",
                        "criterion": "clinical chemistry laboratory parameters",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": "acceptable ranges"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Hematology ... laboratory parameters within acceptable ranges.",
                        "criterion": "hematology laboratory parameters",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": "acceptable ranges"
                        }
                    },
                    {
                        "exact_snippets": "clinical chemistry laboratory parameters within acceptable ranges.",
                        "criterion": "clinical chemistry laboratory parameters",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": "acceptable ranges"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "6. Adequate organ function as defined below:",
                "criterions": [
                    {
                        "exact_snippets": "Adequate organ function",
                        "criterion": "organ function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Adequate organ function",
                        "criterion": "organ function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Hemoglobin ≥9 g/dL",
                "criterions": [
                    {
                        "exact_snippets": "Hemoglobin ≥9 g/dL",
                        "criterion": "hemoglobin",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 9,
                                "unit": "g/dL"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Hemoglobin ≥9 g/dL",
                        "criterion": "hemoglobin",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 9,
                                "unit": "g/dL"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Neutrophil count ≥1.000x10/mcL",
                "criterions": [
                    {
                        "exact_snippets": "Neutrophil count ≥1.000x10/mcL",
                        "criterion": "neutrophil count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.0,
                                "unit": "x10/mcL"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Neutrophil count ≥1.000x10/mcL",
                        "criterion": "neutrophil count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.0,
                                "unit": "x10/mcL"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Platelets ≥100.000/mcL",
                "criterions": [
                    {
                        "exact_snippets": "Platelets ≥100.000/mcL",
                        "criterion": "platelet count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "mcL"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Platelets ≥100.000/mcL",
                        "criterion": "platelet count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "mcL"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* AST (SGOT)/ALT (SGPT) ≤ 2,5 x institutional ULN (or ≤ 5X ULN in the presence of liver metastases)",
                "criterions": [
                    {
                        "exact_snippets": "AST (SGOT)/ALT (SGPT) ≤ 2,5 x institutional ULN",
                        "criterion": "AST (SGOT)/ALT (SGPT) levels",
                        "requirement": {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "x institutional ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "AST (SGOT)/ALT (SGPT) ... ≤ 5X ULN in the presence of liver metastases",
                        "criterion": "AST (SGOT)/ALT (SGPT) levels with liver metastases",
                        "requirement": {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "x ULN"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "in the presence of liver metastases",
                    "criterion": "liver metastases",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                },
                "then_criteria": {
                    "exact_snippets": "AST (SGOT)/ALT (SGPT) ... ≤ 5X ULN in the presence of liver metastases",
                    "criterion": "AST (SGOT)/ALT (SGPT) levels with liver metastases",
                    "requirement": {
                        "requirement_type": "comparison",
                        "expected_value": {
                            "operator": "<=",
                            "value": 5,
                            "unit": "x ULN"
                        }
                    }
                },
                "else_criteria": {
                    "exact_snippets": "AST (SGOT)/ALT (SGPT) ≤ 2,5 x institutional ULN",
                    "criterion": "AST (SGOT)/ALT (SGPT) levels",
                    "requirement": {
                        "requirement_type": "comparison",
                        "expected_value": {
                            "operator": "<=",
                            "value": 2.5,
                            "unit": "x institutional ULN"
                        }
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Creatinine ≤1.5 mg/dL and creatinine CL ≥40 mL/min (calculated using the Cockcroft-Gault formula)",
                "criterions": [
                    {
                        "exact_snippets": "Creatinine ≤1.5 mg/dL",
                        "criterion": "creatinine level",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "mg/dL"
                            }
                        }
                    },
                    {
                        "exact_snippets": "creatinine CL ≥40 mL/min (calculated using the Cockcroft-Gault formula)",
                        "criterion": "creatinine clearance",
                        "requirement": {
                            "requirement_type": "clearance",
                            "expected_value": {
                                "operator": ">=",
                                "value": 40,
                                "unit": "mL/min"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Creatinine ≤1.5 mg/dL",
                        "criterion": "creatinine level",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "mg/dL"
                            }
                        }
                    },
                    {
                        "exact_snippets": "creatinine CL ≥40 mL/min (calculated using the Cockcroft-Gault formula)",
                        "criterion": "creatinine clearance",
                        "requirement": {
                            "requirement_type": "clearance",
                            "expected_value": {
                                "operator": ">=",
                                "value": 40,
                                "unit": "mL/min"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "7. Adequate coagulation profile as defined below:",
                "criterions": [
                    {
                        "exact_snippets": "Adequate coagulation profile",
                        "criterion": "coagulation profile",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Adequate coagulation profile",
                        "criterion": "coagulation profile",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* INR≤ 1,5",
                "criterions": [
                    {
                        "exact_snippets": "INR≤ 1,5",
                        "criterion": "INR",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "N/A"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "INR≤ 1,5",
                        "criterion": "INR",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "N/A"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* aPTT ≤ 1,5 x ULN",
                "criterions": [
                    {
                        "exact_snippets": "aPTT ≤ 1,5 x ULN",
                        "criterion": "aPTT",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "aPTT ≤ 1,5 x ULN",
                        "criterion": "aPTT",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Serum or urine negative pregnancy test for women with childbearing potential.",
                "criterions": [
                    {
                        "exact_snippets": "Serum or urine negative pregnancy test",
                        "criterion": "pregnancy test",
                        "requirement": {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    },
                    {
                        "exact_snippets": "women with childbearing potential",
                        "criterion": "childbearing potential",
                        "requirement": {
                            "requirement_type": "gender",
                            "expected_value": "female"
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "women with childbearing potential",
                    "criterion": "childbearing potential",
                    "requirement": {
                        "requirement_type": "gender",
                        "expected_value": "female"
                    }
                },
                "then_criteria": {
                    "exact_snippets": "Serum or urine negative pregnancy test",
                    "criterion": "pregnancy test",
                    "requirement": {
                        "requirement_type": "result",
                        "expected_value": "negative"
                    }
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "8. No previous antitumor treatment (radiation therapy, systemic treatment, or surgery) in the previous 28 days and current adverse events from them ≤ grade 1.",
                "criterions": [
                    {
                        "exact_snippets": "No previous antitumor treatment (radiation therapy, systemic treatment, or surgery) in the previous 28 days",
                        "criterion": "previous antitumor treatment",
                        "requirement": {
                            "requirement_type": "absence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "current adverse events from them ≤ grade 1",
                        "criterion": "current adverse events from previous antitumor treatment",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "grade"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "No previous antitumor treatment (radiation therapy, systemic treatment, or surgery) in the previous 28 days",
                        "criterion": "previous antitumor treatment",
                        "requirement": {
                            "requirement_type": "absence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "current adverse events from them ≤ grade 1",
                        "criterion": "current adverse events from previous antitumor treatment",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "grade"
                            }
                        }
                    }
                ]
            }
        },
        {
            "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": {
                "and_criteria": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "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": {
                "and_criteria": [
                    {
                        "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. Systemic anti-cancer therapy within 4 weeks prior to study admission.",
                "criterions": [
                    {
                        "exact_snippets": "Systemic anti-cancer therapy within 4 weeks prior to study admission.",
                        "criterion": "systemic anti-cancer therapy",
                        "requirement": {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Systemic anti-cancer therapy within 4 weeks prior to study admission.",
                    "criterion": "systemic anti-cancer therapy",
                    "requirement": {
                        "requirement_type": "time since last treatment",
                        "expected_value": {
                            "operator": "<=",
                            "value": 4,
                            "unit": "weeks"
                        }
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "2. Radiation therapy within 4 weeks prior to study entry.",
                "criterions": [
                    {
                        "exact_snippets": "Radiation therapy within 4 weeks prior to study entry.",
                        "criterion": "radiation therapy",
                        "requirement": {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Radiation therapy within 4 weeks prior to study entry.",
                        "criterion": "radiation therapy",
                        "requirement": {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "3. Any major surgery within 4 weeks before first dose of study treatment No major surgery must be planned during the trial expected treatment. receiving study treatment. Participants with recent surgery with only local anesthesia may be included.",
                "criterions": [
                    {
                        "exact_snippets": "Any major surgery within 4 weeks before first dose of study treatment",
                        "criterion": "major surgery",
                        "requirement": {
                            "requirement_type": "time since surgery",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "No major surgery must be planned during the trial expected treatment",
                        "criterion": "planned major surgery",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Participants with recent surgery with only local anesthesia may be included",
                        "criterion": "recent surgery with only local anesthesia",
                        "requirement": {
                            "requirement_type": "inclusion",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "not_criteria": {
                            "and_criteria": [
                                {
                                    "exact_snippets": "Any major surgery within 4 weeks before first dose of study treatment",
                                    "criterion": "major surgery",
                                    "requirement": {
                                        "requirement_type": "time since surgery",
                                        "expected_value": {
                                            "operator": ">=",
                                            "value": 4,
                                            "unit": "weeks"
                                        }
                                    }
                                },
                                {
                                    "exact_snippets": "No major surgery must be planned during the trial expected treatment",
                                    "criterion": "planned major surgery",
                                    "requirement": {
                                        "requirement_type": "presence",
                                        "expected_value": false
                                    }
                                }
                            ]
                        }
                    },
                    {
                        "exact_snippets": "Participants with recent surgery with only local anesthesia may be included",
                        "criterion": "recent surgery with only local anesthesia",
                        "requirement": {
                            "requirement_type": "inclusion",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "4. Non-malignant systemic disease including cerebrovascular accident, myocardial infarction in the last 6 months, unstable angina pectoris, unstable cardiac arrhythmia, New York Heart Association (NYHA) Class III or IV heart failure, coagulation abnormalities and clinically significant pulmonary compromise, .",
                "criterions": [
                    {
                        "exact_snippets": "cerebrovascular accident",
                        "criterion": "cerebrovascular accident",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "myocardial infarction in the last 6 months",
                        "criterion": "myocardial infarction",
                        "requirement": {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    },
                    {
                        "exact_snippets": "unstable angina pectoris",
                        "criterion": "unstable angina pectoris",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "unstable cardiac arrhythmia",
                        "criterion": "unstable cardiac arrhythmia",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "New York Heart Association (NYHA) Class III or IV heart failure",
                        "criterion": "NYHA heart failure class",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": [
                                "Class III",
                                "Class IV"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "coagulation abnormalities",
                        "criterion": "coagulation abnormalities",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "clinically significant pulmonary compromise",
                        "criterion": "clinically significant pulmonary compromise",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "not_criteria": {
                            "exact_snippets": "cerebrovascular accident",
                            "criterion": "cerebrovascular accident",
                            "requirement": {
                                "requirement_type": "presence",
                                "expected_value": false
                            }
                        }
                    },
                    {
                        "not_criteria": {
                            "exact_snippets": "myocardial infarction in the last 6 months",
                            "criterion": "myocardial infarction",
                            "requirement": {
                                "requirement_type": "time since event",
                                "expected_value": {
                                    "operator": "<=",
                                    "value": 6,
                                    "unit": "months"
                                }
                            }
                        }
                    },
                    {
                        "not_criteria": {
                            "exact_snippets": "unstable angina pectoris",
                            "criterion": "unstable angina pectoris",
                            "requirement": {
                                "requirement_type": "presence",
                                "expected_value": false
                            }
                        }
                    },
                    {
                        "not_criteria": {
                            "exact_snippets": "unstable cardiac arrhythmia",
                            "criterion": "unstable cardiac arrhythmia",
                            "requirement": {
                                "requirement_type": "presence",
                                "expected_value": false
                            }
                        }
                    },
                    {
                        "exact_snippets": "New York Heart Association (NYHA) Class III or IV heart failure",
                        "criterion": "NYHA heart failure class",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": [
                                "Class III",
                                "Class IV"
                            ]
                        }
                    },
                    {
                        "not_criteria": {
                            "exact_snippets": "coagulation abnormalities",
                            "criterion": "coagulation abnormalities",
                            "requirement": {
                                "requirement_type": "presence",
                                "expected_value": false
                            }
                        }
                    },
                    {
                        "not_criteria": {
                            "exact_snippets": "clinically significant pulmonary compromise",
                            "criterion": "clinically significant pulmonary compromise",
                            "requirement": {
                                "requirement_type": "presence",
                                "expected_value": false
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "5. Left ventricular ejection fraction below institutional normal limits.",
                "criterions": [
                    {
                        "exact_snippets": "Left ventricular ejection fraction below institutional normal limits",
                        "criterion": "left ventricular ejection fraction",
                        "requirement": {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": "<",
                                "value": 0,
                                "unit": "institutional normal limits"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Left ventricular ejection fraction below institutional normal limits",
                        "criterion": "left ventricular ejection fraction",
                        "requirement": {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": "<",
                                "value": 0,
                                "unit": "institutional normal limits"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "6. Patients with symptomatic central nervous system (CNS) primary tumor or metastases (including leptomeningeal carcinomatosis). Patients with documented treated CNS metastases stable for at least 4 weeks may be enrolled at the discretion of the investigator.",
                "criterions": [
                    {
                        "exact_snippets": "symptomatic central nervous system (CNS) primary tumor",
                        "criterion": "symptomatic CNS primary tumor",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "symptomatic central nervous system (CNS) ... metastases",
                        "criterion": "symptomatic CNS metastases",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "leptomeningeal carcinomatosis",
                        "criterion": "leptomeningeal carcinomatosis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "documented treated CNS metastases stable for at least 4 weeks",
                        "criterion": "treated CNS metastases stability",
                        "requirement": {
                            "requirement_type": "stability duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "symptomatic central nervous system (CNS) primary tumor",
                                        "criterion": "symptomatic CNS primary tumor",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": false
                                        }
                                    },
                                    {
                                        "exact_snippets": "symptomatic central nervous system (CNS) ... metastases",
                                        "criterion": "symptomatic CNS metastases",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": false
                                        }
                                    },
                                    {
                                        "exact_snippets": "leptomeningeal carcinomatosis",
                                        "criterion": "leptomeningeal carcinomatosis",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": false
                                        }
                                    }
                                ]
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "documented treated CNS metastases stable for at least 4 weeks",
                                        "criterion": "treated CNS metastases stability",
                                        "requirement": {
                                            "requirement_type": "stability duration",
                                            "expected_value": {
                                                "operator": ">=",
                                                "value": 4,
                                                "unit": "weeks"
                                            }
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "7. Breast feeding, pregnancy or not willing to adopt safe contraceptive measures by the patient or the patient's partner, to become pregnant during treatment or within 6 months after the end of treatment.",
                "criterions": [
                    {
                        "exact_snippets": "Breast feeding",
                        "criterion": "breastfeeding",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "pregnancy",
                        "criterion": "pregnancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "not willing to adopt safe contraceptive measures",
                        "criterion": "willingness to adopt safe contraceptive measures",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "to become pregnant during treatment or within 6 months after the end of treatment",
                        "criterion": "pregnancy during or after treatment",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": "not during treatment or within 6 months after treatment"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Breast feeding",
                                "criterion": "breastfeeding",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "pregnancy",
                                "criterion": "pregnancy",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            }
                        ]
                    },
                    {
                        "not_criteria": {
                            "exact_snippets": "not willing to adopt safe contraceptive measures",
                            "criterion": "willingness to adopt safe contraceptive measures",
                            "requirement": {
                                "requirement_type": "willingness",
                                "expected_value": true
                            }
                        }
                    },
                    {
                        "exact_snippets": "to become pregnant during treatment or within 6 months after the end of treatment",
                        "criterion": "pregnancy during or after treatment",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": "not during treatment or within 6 months after treatment"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "8. Patients with active uncontrolled infection or known to be serologically positive for human immunodeficiency virus (HIV), hepatitis B (except HbsAc after vaccination) or hepatitis C infection.",
                "criterions": [
                    {
                        "exact_snippets": "active uncontrolled infection",
                        "criterion": "infection",
                        "requirement": {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    },
                    {
                        "exact_snippets": "active uncontrolled infection",
                        "criterion": "infection",
                        "requirement": {
                            "requirement_type": "activity status",
                            "expected_value": "active"
                        }
                    },
                    {
                        "exact_snippets": "serologically positive for human immunodeficiency virus (HIV)",
                        "criterion": "HIV status",
                        "requirement": {
                            "requirement_type": "serological status",
                            "expected_value": "positive"
                        }
                    },
                    {
                        "exact_snippets": "serologically positive for ... hepatitis B (except HbsAc after vaccination)",
                        "criterion": "hepatitis B status",
                        "requirement": {
                            "requirement_type": "serological status",
                            "expected_value": "positive"
                        }
                    },
                    {
                        "exact_snippets": "serologically positive for ... hepatitis B (except HbsAc after vaccination)",
                        "criterion": "hepatitis B status",
                        "requirement": {
                            "requirement_type": "vaccination status",
                            "expected_value": "not applicable if HbsAc after vaccination"
                        }
                    },
                    {
                        "exact_snippets": "serologically positive for ... hepatitis C infection",
                        "criterion": "hepatitis C status",
                        "requirement": {
                            "requirement_type": "serological status",
                            "expected_value": "positive"
                        }
                    }
                ]
            },
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                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "active uncontrolled infection",
                                "criterion": "infection",
                                "requirement": {
                                    "requirement_type": "control status",
                                    "expected_value": "uncontrolled"
                                }
                            },
                            {
                                "exact_snippets": "active uncontrolled infection",
                                "criterion": "infection",
                                "requirement": {
                                    "requirement_type": "activity status",
                                    "expected_value": "active"
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "serologically positive for human immunodeficiency virus (HIV)",
                        "criterion": "HIV status",
                        "requirement": {
                            "requirement_type": "serological status",
                            "expected_value": "positive"
                        }
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "serologically positive for ... hepatitis B (except HbsAc after vaccination)",
                                "criterion": "hepatitis B status",
                                "requirement": {
                                    "requirement_type": "serological status",
                                    "expected_value": "positive"
                                }
                            },
                            {
                                "not_criteria": {
                                    "exact_snippets": "serologically positive for ... hepatitis B (except HbsAc after vaccination)",
                                    "criterion": "hepatitis B status",
                                    "requirement": {
                                        "requirement_type": "vaccination status",
                                        "expected_value": "not applicable if HbsAc after vaccination"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "serologically positive for ... hepatitis C infection",
                        "criterion": "hepatitis C status",
                        "requirement": {
                            "requirement_type": "serological status",
                            "expected_value": "positive"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "9. Any other diseases or medical condition that may interfere with the planned treatment, compliance, or place the patient at risk if participating in the study, at investigator criteria.",
                "criterions": [
                    {
                        "exact_snippets": "Any other diseases or medical condition that may interfere with the planned treatment",
                        "criterion": "diseases or medical condition",
                        "requirement": {
                            "requirement_type": "interference with treatment",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Any other diseases or medical condition that may interfere with ... compliance",
                        "criterion": "diseases or medical condition",
                        "requirement": {
                            "requirement_type": "interference with compliance",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Any other diseases or medical condition that may ... place the patient at risk",
                        "criterion": "diseases or medical condition",
                        "requirement": {
                            "requirement_type": "risk to patient",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Any other diseases or medical condition that may interfere with the planned treatment",
                                        "criterion": "diseases or medical condition",
                                        "requirement": {
                                            "requirement_type": "interference with treatment",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "Any other diseases or medical condition that may interfere with ... compliance",
                                        "criterion": "diseases or medical condition",
                                        "requirement": {
                                            "requirement_type": "interference with compliance",
                                            "expected_value": true
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "Any other diseases or medical condition that may ... place the patient at risk",
                                "criterion": "diseases or medical condition",
                                "requirement": {
                                    "requirement_type": "risk to patient",
                                    "expected_value": true
                                }
                            }
                        ]
                    }
                ]
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "identified_line": {
                "line": "2. Evaluable (part A) or measurable disease (part B) as per RECIST v1.1 (part A) or mRECIST v1.1. (part B). Progressive disease to the on or following the last line of antitumor treatment.",
                "criterions": [
                    {
                        "exact_snippets": "Evaluable (part A) or measurable disease (part B) as per RECIST v1.1 (part A) or mRECIST v1.1. (part B)",
                        "criterion": "disease status",
                        "requirement": {
                            "requirement_type": "evaluation method",
                            "expected_value": [
                                "RECIST v1.1",
                                "mRECIST v1.1"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "Progressive disease to the on or following the last line of antitumor treatment",
                        "criterion": "disease progression",
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                            "requirement_type": "progression status",
                            "expected_value": "progressive"
                        }
                    }
                ]
            },
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                    {
                        "or_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Evaluable (part A) or measurable disease (part B) as per RECIST v1.1 (part A) or mRECIST v1.1. (part B)",
                                        "criterion": "disease status",
                                        "requirement": {
                                            "requirement_type": "evaluation method",
                                            "expected_value": "RECIST v1.1"
                                        }
                                    },
                                    {
                                        "exact_snippets": "Evaluable (part A) or measurable disease (part B) as per RECIST v1.1 (part A) or mRECIST v1.1. (part B)",
                                        "criterion": "disease status",
                                        "requirement": {
                                            "requirement_type": "evaluation method",
                                            "expected_value": "mRECIST v1.1"
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "Evaluable (part A) or measurable disease (part B) as per RECIST v1.1 (part A) or mRECIST v1.1. (part B)",
                                "criterion": "disease status",
                                "requirement": {
                                    "requirement_type": "evaluation method",
                                    "expected_value": "mRECIST v1.1"
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "Progressive disease to the on or following the last line of antitumor treatment",
                        "criterion": "disease progression",
                        "requirement": {
                            "requirement_type": "progression status",
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                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "3. ECOG performance status ≤ 2.",
                "criterions": [
                    {
                        "exact_snippets": "ECOG performance status ≤ 2",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "ECOG performance status \u0010 2",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Total bilirubin ≤1,5 x Upper Limit of Normal (ULN) (unless Gilbert's Disease)",
                "criterions": [
                    {
                        "exact_snippets": "Total bilirubin ≤1,5 x Upper Limit of Normal (ULN)",
                        "criterion": "total bilirubin",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "unless Gilbert's Disease",
                        "criterion": "Gilbert's Disease",
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                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "Gilbert's Disease",
                    "criterion": "Gilbert's Disease",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": false
                    }
                },
                "then_criteria": {
                    "exact_snippets": "Total bilirubin ≤1,5 x Upper Limit of Normal (ULN)",
                    "criterion": "total bilirubin",
                    "requirement": {
                        "requirement_type": "level",
                        "expected_value": {
                            "operator": "<=",
                            "value": 1.5,
                            "unit": "x ULN"
                        }
                    }
                },
                "else_criteria": null
            }
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}