{
    "info": {
        "nct_id": "NCT03596372",
        "official_title": "An Open-label, Phase 1, First-in-human, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Tumor Response Profile of the Anti-CEACAM6 Antibody BAY1834942 in Patients With Advanced Solid Tumors",
        "inclusion_criteria": "* Male or female patients aged ≥ 18 years\n* Patients with histologically confirmed advanced/ metastatic solid tumors: Dose escalation: solid tumor types with a expression of CEACAM6 (gastric/ GEJ cancer, esophageal cancer, NSCLC, CRC, pancreatic cancer, cervical cancer, breast cancer, bladder cancer, head and neck squamous cell cancer, bile duct cancer); Dose expansion: advanced adeno NSCLC, CRC and gastric/ GEJ adenocarcinoma.\n* ECOG-PS of 0 to 1.\n* Adequate organ function (bone marrow, liver, kidneys).\n* Adequate coagulation function.\n* Adequate cardiac function\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Patients with active symptomatic or untreated brain metastases; possible exceptions for patients with treated asymptomatic central nervous system metastases\n* Active autoimmune disease\n* History or evidence of active pulmonary fibrosis, organizing pneumonia, or pneumonitis.\n* Risk factors for bowel obstruction or bowel perforation\n* History of cardiac disease\n* Uncontrolled arterial hypertension despite optimal medical management\n* Clinically relevant findings in electrocardiogram\n* HIV infection\n* Active HBV or HCV infection",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Male or female patients aged ≥ 18 years",
            "criterions": [
                {
                    "exact_snippets": "Male or female patients",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "aged ≥ 18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with histologically confirmed advanced/ metastatic solid tumors: Dose escalation: solid tumor types with a expression of CEACAM6 (gastric/ GEJ cancer, esophageal cancer, NSCLC, CRC, pancreatic cancer, cervical cancer, breast cancer, bladder cancer, head and neck squamous cell cancer, bile duct cancer); Dose expansion: advanced adeno NSCLC, CRC and gastric/ GEJ adenocarcinoma.",
            "criterions": [
                {
                    "exact_snippets": "histologically confirmed advanced/ metastatic solid tumors",
                    "criterion": "solid tumors",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically confirmed"
                        },
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "advanced",
                                "metastatic"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "solid tumor types with a expression of CEACAM6",
                    "criterion": "CEACAM6 expression",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "gastric/ GEJ cancer, esophageal cancer, NSCLC, CRC, pancreatic cancer, cervical cancer, breast cancer, bladder cancer, head and neck squamous cell cancer, bile duct cancer",
                    "criterion": "solid tumor types",
                    "requirements": [
                        {
                            "requirement_type": "types",
                            "expected_value": [
                                "gastric/ GEJ cancer",
                                "esophageal cancer",
                                "NSCLC",
                                "CRC",
                                "pancreatic cancer",
                                "cervical cancer",
                                "breast cancer",
                                "bladder cancer",
                                "head and neck squamous cell cancer",
                                "bile duct cancer"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "advanced adeno NSCLC, CRC and gastric/ GEJ adenocarcinoma",
                    "criterion": "adenocarcinoma types",
                    "requirements": [
                        {
                            "requirement_type": "types",
                            "expected_value": [
                                "advanced adeno NSCLC",
                                "CRC",
                                "gastric/ GEJ adenocarcinoma"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ECOG-PS of 0 to 1.",
            "criterions": [
                {
                    "exact_snippets": "ECOG-PS of 0 to 1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate organ function (bone marrow, liver, kidneys).",
            "criterions": [
                {
                    "exact_snippets": "Adequate organ function (bone marrow",
                    "criterion": "bone marrow function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate organ function ... liver",
                    "criterion": "liver function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate organ function ... kidneys",
                    "criterion": "kidney function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate coagulation function.",
            "criterions": [
                {
                    "exact_snippets": "Adequate coagulation function.",
                    "criterion": "coagulation function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate cardiac function",
            "criterions": [
                {
                    "exact_snippets": "Adequate cardiac function",
                    "criterion": "cardiac function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Patients with active symptomatic or untreated brain metastases; possible exceptions for patients with treated asymptomatic central nervous system metastases",
            "criterions": [
                {
                    "exact_snippets": "active symptomatic or untreated brain metastases",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        },
                        {
                            "requirement_type": "symptom presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "untreated"
                        }
                    ]
                },
                {
                    "exact_snippets": "treated asymptomatic central nervous system metastases",
                    "criterion": "central nervous system metastases",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "treated"
                        },
                        {
                            "requirement_type": "symptom presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active autoimmune disease",
            "criterions": [
                {
                    "exact_snippets": "Active autoimmune disease",
                    "criterion": "autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "activity status",
                            "expected_value": "active"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History or evidence of active pulmonary fibrosis, organizing pneumonia, or pneumonitis.",
            "criterions": [
                {
                    "exact_snippets": "History or evidence of active pulmonary fibrosis",
                    "criterion": "pulmonary fibrosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History or evidence of ... organizing pneumonia",
                    "criterion": "organizing pneumonia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History or evidence of ... pneumonitis",
                    "criterion": "pneumonitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Risk factors for bowel obstruction or bowel perforation",
            "criterions": [
                {
                    "exact_snippets": "Risk factors for bowel obstruction",
                    "criterion": "bowel obstruction",
                    "requirements": [
                        {
                            "requirement_type": "risk factors",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Risk factors for ... bowel perforation",
                    "criterion": "bowel perforation",
                    "requirements": [
                        {
                            "requirement_type": "risk factors",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of cardiac disease",
            "criterions": [
                {
                    "exact_snippets": "History of cardiac disease",
                    "criterion": "cardiac disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Uncontrolled arterial hypertension despite optimal medical management",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled arterial hypertension",
                    "criterion": "arterial hypertension",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "despite optimal medical management",
                    "criterion": "medical management",
                    "requirements": [
                        {
                            "requirement_type": "effectiveness",
                            "expected_value": "optimal"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Clinically relevant findings in electrocardiogram",
            "criterions": [
                {
                    "exact_snippets": "Clinically relevant findings in electrocardiogram",
                    "criterion": "electrocardiogram",
                    "requirements": [
                        {
                            "requirement_type": "findings",
                            "expected_value": "clinically relevant"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* HIV infection",
            "criterions": [
                {
                    "exact_snippets": "HIV infection",
                    "criterion": "HIV infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active HBV or HCV infection",
            "criterions": [
                {
                    "exact_snippets": "Active HBV",
                    "criterion": "HBV infection",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "active"
                        }
                    ]
                },
                {
                    "exact_snippets": "Active ... HCV infection",
                    "criterion": "HCV infection",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "active"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}