{
    "info": {
        "nct_id": "NCT05010694",
        "official_title": "A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Antitumor Activity of GH35 Tablets in Patients Harboring With G12C Mutation in Advanced Solid Tumors",
        "inclusion_criteria": "1. Male or female subjects greater than or equal to 18 years old.\n2. Histologically or cytologically confirmed diagnosis of advanced/metastatic solid tumor with KRAS mutation identified.\n3. Expected survival time ≥12 weeks.\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n5. Must have at least one measureable lesion per Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1.\n6. Have documented disease progression or intolerance after first-line treatment.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Gastrointestinal (GI) tract disease causing the inability to take oral medication.\n2. Previous accept with KRAS G12C inhibitor.\n3. Uncontrollable general infection.\n4. Serious cardiovascular disease.\n5. Left ventricular ejection fraction (LVEF) <50 %.\n6. Known history of hypersensitivity to any of the excipients of GH35 tablets\n7. Pregnant or nursing (lactating) women.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Male or female subjects greater than or equal to 18 years old.",
            "criterions": [
                {
                    "exact_snippets": "Male or female subjects",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "greater than or equal to 18 years old",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Histologically or cytologically confirmed diagnosis of advanced/metastatic solid tumor with KRAS mutation identified.",
            "criterions": [
                {
                    "exact_snippets": "Histologically or cytologically confirmed diagnosis",
                    "criterion": "diagnosis confirmation",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "advanced/metastatic solid tumor",
                    "criterion": "tumor type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "advanced/metastatic solid tumor"
                        }
                    ]
                },
                {
                    "exact_snippets": "KRAS mutation identified",
                    "criterion": "KRAS mutation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Expected survival time ≥12 weeks.",
            "criterions": [
                {
                    "exact_snippets": "Expected survival time ≥12 weeks.",
                    "criterion": "survival time",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Must have at least one measureable lesion per Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1.",
            "criterions": [
                {
                    "exact_snippets": "at least one measureable lesion",
                    "criterion": "measurable lesion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "lesion"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Have documented disease progression or intolerance after first-line treatment.",
            "criterions": [
                {
                    "exact_snippets": "documented disease progression",
                    "criterion": "disease progression",
                    "requirements": [
                        {
                            "requirement_type": "documentation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "intolerance after first-line treatment",
                    "criterion": "treatment intolerance",
                    "requirements": [
                        {
                            "requirement_type": "treatment line",
                            "expected_value": "first-line"
                        }
                    ]
                }
            ]
        },
        {
            "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. Gastrointestinal (GI) tract disease causing the inability to take oral medication.",
            "criterions": [
                {
                    "exact_snippets": "Gastrointestinal (GI) tract disease",
                    "criterion": "Gastrointestinal (GI) tract disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "causing the inability to take oral medication",
                    "criterion": "inability to take oral medication",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Previous accept with KRAS G12C inhibitor.",
            "criterions": [
                {
                    "exact_snippets": "Previous accept with KRAS G12C inhibitor",
                    "criterion": "KRAS G12C inhibitor",
                    "requirements": [
                        {
                            "requirement_type": "previous acceptance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Uncontrollable general infection.",
            "criterions": [
                {
                    "exact_snippets": "Uncontrollable general infection",
                    "criterion": "general infection",
                    "requirements": [
                        {
                            "requirement_type": "controllability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Serious cardiovascular disease.",
            "criterions": [
                {
                    "exact_snippets": "Serious cardiovascular disease",
                    "criterion": "cardiovascular disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Left ventricular ejection fraction (LVEF) <50 %.",
            "criterions": [
                {
                    "exact_snippets": "Left ventricular ejection fraction (LVEF) <50 %",
                    "criterion": "left ventricular ejection fraction (LVEF)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 50,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Known history of hypersensitivity to any of the excipients of GH35 tablets",
            "criterions": [
                {
                    "exact_snippets": "Known history of hypersensitivity to any of the excipients of GH35 tablets",
                    "criterion": "hypersensitivity to excipients of GH35 tablets",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Pregnant or nursing (lactating) women.",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "nursing (lactating)",
                    "criterion": "nursing",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}