{
    "info": {
        "nct_id": "NCT05867420",
        "official_title": "A Phase 1 Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ASKG915 as a Single Agent in Patients With Selected Advanced Solid Tumors.",
        "inclusion_criteria": "1. Histologically or cytologically confirmed advanced malignant tumor that is refractory to or intolerant of all standard therapy or for which no standard therapy is available.\n2. ECOG performance status of ≤ 2.\n3. Life expectancy of ≥ 3 months.\n4. The results of the laboratory tests must meet all criteria.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Patients have received antitumor therapy during the first 4 weeks before study drug use.\n2. Received a live attenuated vaccine within 4 weeks prior to C1D1.\n3. Known cerebral parenchymal metastasis or meningeal metastasis.\n4. History of serious cardiovascular or cerebrovascular diseases.\n5. Active or recurrent autoimmune diseases.\n6. History of ascites or pleural effusion requiring drainage.\n7. Pregnant or lactating or planning to become pregnant at any time during the study, including the Follow-up Period.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Histologically or cytologically confirmed advanced malignant tumor that is refractory to or intolerant of all standard therapy or for which no standard therapy is available.",
            "criterions": [
                {
                    "exact_snippets": "Histologically or cytologically confirmed advanced malignant tumor",
                    "criterion": "advanced malignant tumor",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "refractory to or intolerant of all standard therapy",
                    "criterion": "standard therapy",
                    "requirements": [
                        {
                            "requirement_type": "response",
                            "expected_value": [
                                "refractory",
                                "intolerant"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "for which no standard therapy is available",
                    "criterion": "standard therapy",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. ECOG performance status of ≤ 2.",
            "criterions": [
                {
                    "exact_snippets": "ECOG performance status of ≤ 2",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Life expectancy of ≥ 3 months.",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy of ≥ 3 months.",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. The results of the laboratory tests must meet all criteria.",
            "criterions": [
                {
                    "exact_snippets": "results of the laboratory tests",
                    "criterion": "laboratory test results",
                    "requirements": [
                        {
                            "requirement_type": "criteria",
                            "expected_value": "must meet all criteria"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Patients have received antitumor therapy during the first 4 weeks before study drug use.",
            "criterions": [
                {
                    "exact_snippets": "Patients have received antitumor therapy",
                    "criterion": "antitumor therapy",
                    "requirements": [
                        {
                            "requirement_type": "receipt",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "during the first 4 weeks before study drug use",
                    "criterion": "time since last antitumor therapy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Received a live attenuated vaccine within 4 weeks prior to C1D1.",
            "criterions": [
                {
                    "exact_snippets": "Received a live attenuated vaccine within 4 weeks prior to C1D1.",
                    "criterion": "live attenuated vaccine",
                    "requirements": [
                        {
                            "requirement_type": "receipt",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Known cerebral parenchymal metastasis or meningeal metastasis.",
            "criterions": [
                {
                    "exact_snippets": "Known cerebral parenchymal metastasis",
                    "criterion": "cerebral parenchymal metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "meningeal metastasis",
                    "criterion": "meningeal metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. History of serious cardiovascular or cerebrovascular diseases.",
            "criterions": [
                {
                    "exact_snippets": "History of serious cardiovascular ... diseases.",
                    "criterion": "cardiovascular diseases",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        },
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of serious ... cerebrovascular diseases.",
                    "criterion": "cerebrovascular diseases",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        },
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Active or recurrent autoimmune diseases.",
            "criterions": [
                {
                    "exact_snippets": "Active or recurrent autoimmune diseases",
                    "criterion": "autoimmune diseases",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "active",
                                "recurrent"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. History of ascites or pleural effusion requiring drainage.",
            "criterions": [
                {
                    "exact_snippets": "History of ascites",
                    "criterion": "ascites",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "severity",
                            "expected_value": "requiring drainage"
                        }
                    ]
                },
                {
                    "exact_snippets": "History of ... pleural effusion requiring drainage",
                    "criterion": "pleural effusion",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "severity",
                            "expected_value": "requiring drainage"
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Pregnant or lactating or planning to become pregnant at any time during the study, including the Follow-up Period.",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "lactating",
                    "criterion": "lactation status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "planning to become pregnant",
                    "criterion": "pregnancy planning",
                    "requirements": [
                        {
                            "requirement_type": "intention",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}