{
    "info": {
        "nct_id": "NCT05036291",
        "official_title": "A Phase 1, Open-label, Multicenter Study to Assess the Safety, Tolerability, and Pharmacokinetics of NB004 Administered As Monotherapy or Combination Therapy in Subjects with Advanced Solid Tumors",
        "inclusion_criteria": "1. males or females of any race>(=)18 years age.\n2. Histologically and/or cytologically confirmed diagnosis of advanced solid tumors that are without standard treatment options (part 1).\n\n   Pathologically confirmed locally advanced or metastatic solid tumors with KRAS G12C mutation as determined by a test that has been approved by FDA or local health authority (part 2&3).\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n4. Life expectancy>(=)12 weeks.\n5. Adequate organ and marrow function.\n6. Measurable or evaluable disease.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Prior anti-cancer therapy within 2 weeks or at least 5 half-lives, whichever is longer, up to a maximum of 3 weeks, before the first dose.\n2. Toxicities from previous anti-cancer therapy that have not recovered as required.\n3. Brain metastatic disease, spinal cord compression, or leptomeningeal carcinomatosis.\n4. Active infection including hepatitis B, hepatitis C, and human immunodeficiency virus (HIV):\n5. Female subjects who are pregnant, or breastfeeding, or planning to become pregnant while in this study or within 3 months after the last dose.\n6. Male subjects who plan to father a child while enrolled in the study or within 3 months after the last dose.\n7. Received prior treatment with a PIM kinase inhibitor.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. males or females of any race>(=)18 years age.",
            "criterions": [
                {
                    "exact_snippets": "males or females",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "allowed_values",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "any race",
                    "criterion": "race",
                    "requirements": [
                        {
                            "requirement_type": "allowed_values",
                            "expected_value": "any"
                        }
                    ]
                },
                {
                    "exact_snippets": "(=)18 years age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Histologically and/or cytologically confirmed diagnosis of advanced solid tumors that are without standard treatment options (part 1).",
            "criterions": [
                {
                    "exact_snippets": "Histologically and/or cytologically confirmed diagnosis",
                    "criterion": "diagnosis confirmation method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "advanced solid tumors",
                    "criterion": "tumor type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "advanced solid tumors"
                        }
                    ]
                },
                {
                    "exact_snippets": "without standard treatment options",
                    "criterion": "treatment options",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "Pathologically confirmed locally advanced or metastatic solid tumors with KRAS G12C mutation as determined by a test that has been approved by FDA or local health authority (part 2&3).",
            "criterions": [
                {
                    "exact_snippets": "Pathologically confirmed locally advanced or metastatic solid tumors",
                    "criterion": "solid tumors",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "pathologically confirmed"
                        },
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "locally advanced",
                                "metastatic"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "KRAS G12C mutation",
                    "criterion": "KRAS mutation",
                    "requirements": [
                        {
                            "requirement_type": "mutation type",
                            "expected_value": "G12C"
                        }
                    ]
                },
                {
                    "exact_snippets": "as determined by a test that has been approved by FDA or local health authority",
                    "criterion": "test approval",
                    "requirements": [
                        {
                            "requirement_type": "approval",
                            "expected_value": [
                                "FDA",
                                "local health authority"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. 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": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Life expectancy>(=)12 weeks.",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy>(=)12 weeks.",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Adequate organ and marrow function.",
            "criterions": [
                {
                    "exact_snippets": "Adequate organ and marrow function.",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate organ and marrow function.",
                    "criterion": "marrow function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Measurable or evaluable disease.",
            "criterions": [
                {
                    "exact_snippets": "Measurable or evaluable disease",
                    "criterion": "disease",
                    "requirements": [
                        {
                            "requirement_type": "measurability",
                            "expected_value": [
                                "measurable",
                                "evaluable"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "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. Prior anti-cancer therapy within 2 weeks or at least 5 half-lives, whichever is longer, up to a maximum of 3 weeks, before the first dose.",
            "criterions": [
                {
                    "exact_snippets": "Prior anti-cancer therapy within 2 weeks or at least 5 half-lives, whichever is longer, up to a maximum of 3 weeks, before the first dose.",
                    "criterion": "prior anti-cancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last therapy",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 2,
                                        "unit": "weeks"
                                    },
                                    {
                                        "operator": ">=",
                                        "value": 5,
                                        "unit": "half-lives"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Toxicities from previous anti-cancer therapy that have not recovered as required.",
            "criterions": [
                {
                    "exact_snippets": "Toxicities from previous anti-cancer therapy that have not recovered",
                    "criterion": "toxicities from previous anti-cancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "recovery",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Brain metastatic disease, spinal cord compression, or leptomeningeal carcinomatosis.",
            "criterions": [
                {
                    "exact_snippets": "Brain metastatic disease",
                    "criterion": "brain metastatic disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "spinal cord compression",
                    "criterion": "spinal cord compression",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "leptomeningeal carcinomatosis",
                    "criterion": "leptomeningeal carcinomatosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Active infection including hepatitis B, hepatitis C, and human immunodeficiency virus (HIV):",
            "criterions": [
                {
                    "exact_snippets": "Active infection including hepatitis B",
                    "criterion": "hepatitis B infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Active infection including ... hepatitis C",
                    "criterion": "hepatitis C infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Active infection including ... human immunodeficiency virus (HIV)",
                    "criterion": "HIV infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Female subjects who are pregnant, or breastfeeding, or planning to become pregnant while in this study or within 3 months after the last dose.",
            "criterions": [
                {
                    "exact_snippets": "Female subjects who are pregnant",
                    "criterion": "pregnancy status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breastfeeding",
                    "criterion": "breastfeeding status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "planning to become pregnant while in this study or within 3 months after the last dose",
                    "criterion": "pregnancy planning",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Male subjects who plan to father a child while enrolled in the study or within 3 months after the last dose.",
            "criterions": [
                {
                    "exact_snippets": "Male subjects",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "male"
                        }
                    ]
                },
                {
                    "exact_snippets": "plan to father a child while enrolled in the study or within 3 months after the last dose",
                    "criterion": "reproductive plans",
                    "requirements": [
                        {
                            "requirement_type": "intention",
                            "expected_value": "plan to father a child"
                        },
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "while enrolled in the study or within 3 months after the last dose"
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Received prior treatment with a PIM kinase inhibitor.",
            "criterions": [
                {
                    "exact_snippets": "Received prior treatment with a PIM kinase inhibitor",
                    "criterion": "prior treatment with a PIM kinase inhibitor",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}