{
    "info": {
        "nct_id": "NCT06345001",
        "official_title": "An Open-label Phase 1 Imaging Study to Evaluate the Biodistribution, Dosimetry, Safety and Pharmacokinetics of BAY 3630942, a 89Zr-labeled Monoclonal Antibody, With a Pre-infusion of BAY 3547922, a Monoclonal Antibody-chelator Conjugate, in Patients With Hepatocellular Carcinoma or Other Select Solid Tumors.",
        "inclusion_criteria": "* Participant (male or female) must be 18 years of age inclusive, at the time of signing the informed consent.\n* Histologically confirmed HCC or non-invasive diagnosis of HCC according to American Association for the Study of Liver Diseases (AASLD) criteria\n* Histologically or cytologically confirmed solid tumors\n* Child-Pugh class A and B7\n* Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1\n* Able to tolerate the study procedures, including 3 PET/CT scans\n* Adequate bone marrow, hepatic, and renal function\n* Agreed to take proper contraception measures\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Impaired cardiac function or clinically significant cardiac disease (i.e., congestive heart failure New York Heart Association [NYHA] Class II, III or IV).\n* Patients with arterial thrombotic or embolic events or venous pulmonary embolism within 3 months before the start of study intervention.\n* On-going systemic anticancer therapy except continued luteinizing hormone-releasing hormone (LHRH) agonist or antagonists in participants with prostate adenocarcinoma\n* Administered a radioisotope within 9 physical half-lives of that radioisotope (24 days for yttrium-90 or 90Y) before administration of the study interventions\n* Any local or locoregional therapy of intrahepatic tumor lesions, open biopsy or significant traumatic injury < 4 weeks before administration of the study interventions.\n* Known hypersensitivity to human monoclonal antibodies.\n* Any condition which, in the opinion of the Investigator, would preclude participation in this study.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Participant (male or female) must be 18 years of age inclusive, at the time of signing the informed consent.",
            "criterions": [
                {
                    "exact_snippets": "Participant (male or female) must be 18 years of age inclusive",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Histologically confirmed HCC or non-invasive diagnosis of HCC according to American Association for the Study of Liver Diseases (AASLD) criteria",
            "criterions": [
                {
                    "exact_snippets": "Histologically confirmed HCC",
                    "criterion": "HCC diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                },
                {
                    "exact_snippets": "non-invasive diagnosis of HCC according to American Association for the Study of Liver Diseases (AASLD) criteria",
                    "criterion": "HCC diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": "non-invasive according to AASLD criteria"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Histologically or cytologically confirmed solid tumors",
            "criterions": [
                {
                    "exact_snippets": "Histologically or cytologically confirmed solid tumors",
                    "criterion": "solid tumors",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Child-Pugh class A and B7",
            "criterions": [
                {
                    "exact_snippets": "Child-Pugh class A",
                    "criterion": "Child-Pugh class",
                    "requirements": [
                        {
                            "requirement_type": "classification",
                            "expected_value": "A"
                        }
                    ]
                },
                {
                    "exact_snippets": "Child-Pugh class ... B7",
                    "criterion": "Child-Pugh class",
                    "requirements": [
                        {
                            "requirement_type": "classification",
                            "expected_value": "B7"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1",
                    "criterion": "Eastern Cooperative Oncology Group performance status (ECOG PS)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Able to tolerate the study procedures, including 3 PET/CT scans",
            "criterions": [
                {
                    "exact_snippets": "Able to tolerate the study procedures, including 3 PET/CT scans",
                    "criterion": "tolerance to study procedures",
                    "requirements": [
                        {
                            "requirement_type": "tolerance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate bone marrow, hepatic, and renal function",
            "criterions": [
                {
                    "exact_snippets": "Adequate bone marrow",
                    "criterion": "bone marrow function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate ... hepatic",
                    "criterion": "hepatic function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate ... renal function",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Agreed to take proper contraception measures",
            "criterions": [
                {
                    "exact_snippets": "Agreed to take proper contraception measures",
                    "criterion": "contraception measures",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "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": "* Impaired cardiac function or clinically significant cardiac disease (i.e., congestive heart failure New York Heart Association [NYHA] Class II, III or IV).",
            "criterions": [
                {
                    "exact_snippets": "Impaired cardiac function",
                    "criterion": "cardiac function",
                    "requirements": [
                        {
                            "requirement_type": "impairment",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "clinically significant cardiac disease",
                    "criterion": "cardiac disease",
                    "requirements": [
                        {
                            "requirement_type": "clinical significance",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "congestive heart failure New York Heart Association [NYHA] Class II, III or IV",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "NYHA Class",
                            "expected_value": [
                                "II",
                                "III",
                                "IV"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with arterial thrombotic or embolic events or venous pulmonary embolism within 3 months before the start of study intervention.",
            "criterions": [
                {
                    "exact_snippets": "arterial thrombotic or embolic events",
                    "criterion": "arterial thrombotic or embolic events",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "venous pulmonary embolism",
                    "criterion": "venous pulmonary embolism",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "within 3 months before the start of study intervention",
                    "criterion": "time since event",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* On-going systemic anticancer therapy except continued luteinizing hormone-releasing hormone (LHRH) agonist or antagonists in participants with prostate adenocarcinoma",
            "criterions": [
                {
                    "exact_snippets": "On-going systemic anticancer therapy",
                    "criterion": "systemic anticancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "continued luteinizing hormone-releasing hormone (LHRH) agonist or antagonists",
                    "criterion": "LHRH agonist or antagonists",
                    "requirements": [
                        {
                            "requirement_type": "continuation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "prostate adenocarcinoma",
                    "criterion": "prostate adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Administered a radioisotope within 9 physical half-lives of that radioisotope (24 days for yttrium-90 or 90Y) before administration of the study interventions",
            "criterions": [
                {
                    "exact_snippets": "Administered a radioisotope within 9 physical half-lives of that radioisotope",
                    "criterion": "radioisotope administration",
                    "requirements": [
                        {
                            "requirement_type": "time since administration",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 9,
                                        "unit": "physical half-lives"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "(24 days for yttrium-90 or 90Y)",
                    "criterion": "yttrium-90 administration",
                    "requirements": [
                        {
                            "requirement_type": "time since administration",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 24,
                                        "unit": "days"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any local or locoregional therapy of intrahepatic tumor lesions, open biopsy or significant traumatic injury < 4 weeks before administration of the study interventions.",
            "criterions": [
                {
                    "exact_snippets": "Any local or locoregional therapy of intrahepatic tumor lesions",
                    "criterion": "local or locoregional therapy of intrahepatic tumor lesions",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "open biopsy",
                    "criterion": "open biopsy",
                    "requirements": [
                        {
                            "requirement_type": "time since procedure",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "significant traumatic injury",
                    "criterion": "significant traumatic injury",
                    "requirements": [
                        {
                            "requirement_type": "time since injury",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known hypersensitivity to human monoclonal antibodies.",
            "criterions": [
                {
                    "exact_snippets": "Known hypersensitivity to human monoclonal antibodies.",
                    "criterion": "hypersensitivity",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any condition which, in the opinion of the Investigator, would preclude participation in this study.",
            "criterions": [
                {
                    "exact_snippets": "Any condition which, in the opinion of the Investigator, would preclude participation in this study.",
                    "criterion": "condition precluding participation",
                    "requirements": [
                        {
                            "requirement_type": "opinion",
                            "expected_value": "Investigator's discretion"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}