{
    "info": {
        "nct_id": "NCT05971862",
        "official_title": "An Open-label, Multi-center, Dose-escalation and Dose-finding, Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of SKI- G-801 as Monotherapy in Patients With Advanced Solid Tumors",
        "inclusion_criteria": "* Male and female adults aged 19 years and older\n* Subjects with histologically and/or cytologically confirmed, unresectable advanced or metastatic solid tumors that are confirmed as PD after the standard of care currently known to have clinical benefits, or for which no currently available standard therapies exist due to intolerance, ineligibility, refusal, etc.\n* At least 1 evaluable lesion based on RECIST version 1.1 (the irradiated area or biopsied lesion will be considered evaluable if PD is demonstrated).\n* The Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1\n* Life expectancy of at least 12 weeks\n* The last screening test results obtained within 7 days prior to the first dose of the IP (baseline) meet the following (with no administration of granulocyte colony-stimulating factor [G-CSF] or erythropoietin [EPO], or transfusion within 14 days prior to the laboratory tests)\n\n  1. Hematological function ANC ≥1,500/μL Hemoglobin ≥9 g/dL Platelet count ≥100,000/μL\n  2. Renal function: Creatinine clearance (CrCl) ≥45 mL/min (MDRD equation)\n  3. Hepatic function AST ≤2.0 × ULN ALT ≤2.0 × ULN (AST/ALT ≤5 × ULN, if hepatic metastasis is confirmed) Total bilirubin ≤1.5 × ULN (<3.0 × ULN, if Gilbert's syndrome is confirmed)\n  4. Blood coagulation function: prothrombin time (PT) (international normalized ratio [INR]) and activated partial thromboplastin time (aPTT) ≤1.5 × ULN (with an exception of PT or aPTT in the therapeutic range as per the purpose of anticoagulants if the subject is taking anticoagulants such as warfarin, heparin, or low molecular weight heparin)\n* Voluntary written consent to participate in this study\nHealthy volunteers allowed\nMust have minimum age of 19 Years",
        "exclusion_criteria": "* 7th line or greater palliative systemic anti-cancer therapy for advanced or metastatic solid tumors (postoperative adjuvant therapy is considered as a single line of therapy if the disease recurs within 6 months after the last treatment, while endocrine therapy is excluded from the line of therapy)\n* History of AXL inhibitors\n* Difficulty (e.g., problem swallowing) in oral administration of SKI-G-801 or disease (celiac disease, Crohn's disease, or intestinal resection which is clinically significant or impacts absorption) which impact absorption\n* Hypersensitivity to the active ingredient or excipients of SKI-G-801\n* Major surgery within 4 weeks prior to IP administration\n* Minor surgery within 2 weeks prior to IP administration\n* Women who have a positive pregnancy test or are pregnant or breastfeeding at screening, or female subjects of childbearing potential or male subjects who do not agree to remain abstinent or use effective methods of contraception** for at least 27 weeks (female subjects) or 14 weeks (male subjects) after the last dose of the IP\n\n  **Effective forms of contraception are defined as the following:\n  1. Hormonal contraceptives (implants, injectables, oral contraceptives, etc.)\n  2. Intrauterine device or intrauterine system (copper loop, hormone containing intrauterine system)\n  3. Surgical sterilization (vasectomy, tubal ligation, etc.) of a subject or spouse (or partner)\n  4. Double-barrier method with spermicide (including condom, diaphragm, vaginal sponge, or cervical cap; a male and a female condom must not be used together)\n* Toxicity associated with prior anti-cancer therapy that does not resolve to Grade ≤1 or baseline (with the exceptions of alopecia [any grade], Grade ≤2 neuropathy, and endocrinopathy that is not controlled by hormone replacement therapy)\n* History of using another investigational product/device within 4 weeks (or 5 half-lives, whichever is shorter) prior to IP administration\n* Ineligibility or inability to participate in the study at the judgement of the investigator",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Male and female adults aged 19 years and older",
            "criterions": [
                {
                    "exact_snippets": "Male and female",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "adults aged 19 years and older",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 19,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects with histologically and/or cytologically confirmed, unresectable advanced or metastatic solid tumors that are confirmed as PD after the standard of care currently known to have clinical benefits, or for which no currently available standard therapies exist due to intolerance, ineligibility, refusal, etc.",
            "criterions": [
                {
                    "exact_snippets": "histologically and/or cytologically confirmed",
                    "criterion": "tumor confirmation method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "unresectable advanced or metastatic solid tumors",
                    "criterion": "tumor resectability and stage",
                    "requirements": [
                        {
                            "requirement_type": "resectability",
                            "expected_value": "unresectable"
                        },
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "advanced",
                                "metastatic"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "confirmed as PD after the standard of care",
                    "criterion": "tumor progression",
                    "requirements": [
                        {
                            "requirement_type": "progression status",
                            "expected_value": "PD"
                        }
                    ]
                },
                {
                    "exact_snippets": "standard of care currently known to have clinical benefits, or for which no currently available standard therapies exist due to intolerance, ineligibility, refusal, etc.",
                    "criterion": "standard therapy availability and response",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "response",
                            "expected_value": [
                                "intolerance",
                                "ineligibility",
                                "refusal"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* At least 1 evaluable lesion based on RECIST version 1.1 (the irradiated area or biopsied lesion will be considered evaluable if PD is demonstrated).",
            "criterions": [
                {
                    "exact_snippets": "At least 1 evaluable lesion based on RECIST version 1.1",
                    "criterion": "evaluable lesion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        },
                        {
                            "requirement_type": "evaluation standard",
                            "expected_value": "RECIST version 1.1"
                        }
                    ]
                },
                {
                    "exact_snippets": "the irradiated area or biopsied lesion will be considered evaluable if PD is demonstrated",
                    "criterion": "irradiated area or biopsied lesion",
                    "requirements": [
                        {
                            "requirement_type": "evaluable condition",
                            "expected_value": "PD is demonstrated"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1",
            "criterions": [
                {
                    "exact_snippets": "The Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Life expectancy of at least 12 weeks",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy of at least 12 weeks",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The last screening test results obtained within 7 days prior to the first dose of the IP (baseline) meet the following (with no administration of granulocyte colony-stimulating factor [G-CSF] or erythropoietin [EPO], or transfusion within 14 days prior to the laboratory tests)",
            "criterions": [
                {
                    "exact_snippets": "The last screening test results obtained within 7 days prior to the first dose of the IP (baseline)",
                    "criterion": "screening test results timing",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<=",
                                "value": 7,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "no administration of granulocyte colony-stimulating factor [G-CSF]",
                    "criterion": "granulocyte colony-stimulating factor (G-CSF) administration",
                    "requirements": [
                        {
                            "requirement_type": "administration",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "no administration of ... erythropoietin [EPO]",
                    "criterion": "erythropoietin (EPO) administration",
                    "requirements": [
                        {
                            "requirement_type": "administration",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "no ... transfusion within 14 days prior to the laboratory tests",
                    "criterion": "transfusion",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": ">=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. Hematological function ANC ≥1,500/μL Hemoglobin ≥9 g/dL Platelet count ≥100,000/μL",
            "criterions": [
                {
                    "exact_snippets": "Hematological function ANC ≥1,500/μL",
                    "criterion": "ANC (Absolute Neutrophil Count)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "μL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Hematological function ... Hemoglobin ≥9 g/dL",
                    "criterion": "Hemoglobin",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 9,
                                "unit": "g/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Hematological function ... Platelet count ≥100,000/μL",
                    "criterion": "Platelet count",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "μL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Renal function: Creatinine clearance (CrCl) ≥45 mL/min (MDRD equation)",
            "criterions": [
                {
                    "exact_snippets": "Renal function: Creatinine clearance (CrCl) ≥45 mL/min",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "creatinine clearance",
                            "expected_value": {
                                "operator": ">=",
                                "value": 45,
                                "unit": "mL/min"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Hepatic function AST ≤2.0 × ULN ALT ≤2.0 × ULN (AST/ALT ≤5 × ULN, if hepatic metastasis is confirmed) Total bilirubin ≤1.5 × ULN (<3.0 × ULN, if Gilbert's syndrome is confirmed)",
            "criterions": [
                {
                    "exact_snippets": "Hepatic function AST ≤2.0 × ULN",
                    "criterion": "AST",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.0,
                                "unit": "× ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Hepatic function ... ALT ≤2.0 × ULN",
                    "criterion": "ALT",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.0,
                                "unit": "× ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "AST/ALT ≤5 × ULN, if hepatic metastasis is confirmed",
                    "criterion": "AST/ALT",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "× ULN"
                            }
                        },
                        {
                            "requirement_type": "condition",
                            "expected_value": "hepatic metastasis is confirmed"
                        }
                    ]
                },
                {
                    "exact_snippets": "Total bilirubin ≤1.5 × ULN",
                    "criterion": "Total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "× ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Total bilirubin ... <3.0 × ULN, if Gilbert's syndrome is confirmed",
                    "criterion": "Total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 3.0,
                                "unit": "× ULN"
                            }
                        },
                        {
                            "requirement_type": "condition",
                            "expected_value": "Gilbert's syndrome is confirmed"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Blood coagulation function: prothrombin time (PT) (international normalized ratio [INR]) and activated partial thromboplastin time (aPTT) ≤1.5 × ULN (with an exception of PT or aPTT in the therapeutic range as per the purpose of anticoagulants if the subject is taking anticoagulants such as warfarin, heparin, or low molecular weight heparin)",
            "criterions": [
                {
                    "exact_snippets": "Blood coagulation function: prothrombin time (PT) (international normalized ratio [INR]) ... ≤1.5 × ULN",
                    "criterion": "prothrombin time (PT) (international normalized ratio [INR])",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "× ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Blood coagulation function: ... activated partial thromboplastin time (aPTT) ≤1.5 × ULN",
                    "criterion": "activated partial thromboplastin time (aPTT)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "× ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "with an exception of PT or aPTT in the therapeutic range as per the purpose of anticoagulants if the subject is taking anticoagulants such as warfarin, heparin, or low molecular weight heparin",
                    "criterion": "anticoagulant use",
                    "requirements": [
                        {
                            "requirement_type": "medication",
                            "expected_value": [
                                "warfarin",
                                "heparin",
                                "low molecular weight heparin"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Voluntary written consent to participate in this study",
            "criterions": [
                {
                    "exact_snippets": "Voluntary written consent to participate in this study",
                    "criterion": "consent to participate",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "voluntary written"
                        }
                    ]
                }
            ]
        },
        {
            "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 19 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 19 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 19,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* 7th line or greater palliative systemic anti-cancer therapy for advanced or metastatic solid tumors (postoperative adjuvant therapy is considered as a single line of therapy if the disease recurs within 6 months after the last treatment, while endocrine therapy is excluded from the line of therapy)",
            "criterions": [
                {
                    "exact_snippets": "7th line or greater palliative systemic anti-cancer therapy",
                    "criterion": "line of palliative systemic anti-cancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 7,
                                "unit": "line"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "advanced or metastatic solid tumors",
                    "criterion": "tumor stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "advanced",
                                "metastatic"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "postoperative adjuvant therapy is considered as a single line of therapy if the disease recurs within 6 months after the last treatment",
                    "criterion": "postoperative adjuvant therapy",
                    "requirements": [
                        {
                            "requirement_type": "consideration as a line of therapy",
                            "expected_value": "single line if recurrence within 6 months"
                        }
                    ]
                },
                {
                    "exact_snippets": "endocrine therapy is excluded from the line of therapy",
                    "criterion": "endocrine therapy",
                    "requirements": [
                        {
                            "requirement_type": "inclusion in line of therapy count",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of AXL inhibitors",
            "criterions": [
                {
                    "exact_snippets": "History of AXL inhibitors",
                    "criterion": "AXL inhibitors",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Difficulty (e.g., problem swallowing) in oral administration of SKI-G-801 or disease (celiac disease, Crohn's disease, or intestinal resection which is clinically significant or impacts absorption) which impact absorption",
            "criterions": [
                {
                    "exact_snippets": "Difficulty (e.g., problem swallowing) in oral administration of SKI-G-801",
                    "criterion": "difficulty in oral administration",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "disease (celiac disease, Crohn's disease, or intestinal resection which is clinically significant or impacts absorption)",
                    "criterion": "disease impacting absorption",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "celiac disease",
                                "Crohn's disease",
                                "intestinal resection"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hypersensitivity to the active ingredient or excipients of SKI-G-801",
            "criterions": [
                {
                    "exact_snippets": "Hypersensitivity to the active ingredient",
                    "criterion": "hypersensitivity to active ingredient",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Hypersensitivity to ... excipients of SKI-G-801",
                    "criterion": "hypersensitivity to excipients of SKI-G-801",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Major surgery within 4 weeks prior to IP administration",
            "criterions": [
                {
                    "exact_snippets": "Major surgery within 4 weeks prior to IP administration",
                    "criterion": "major surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Minor surgery within 2 weeks prior to IP administration",
            "criterions": [
                {
                    "exact_snippets": "Minor surgery within 2 weeks prior to IP administration",
                    "criterion": "minor surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Women who have a positive pregnancy test or are pregnant or breastfeeding at screening, or female subjects of childbearing potential or male subjects who do not agree to remain abstinent or use effective methods of contraception** for at least 27 weeks (female subjects) or 14 weeks (male subjects) after the last dose of the IP",
            "criterions": [
                {
                    "exact_snippets": "Women who have a positive pregnancy test",
                    "criterion": "positive pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "breastfeeding at screening",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "female subjects of childbearing potential",
                    "criterion": "female subjects of childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "male subjects who do not agree to remain abstinent or use effective methods of contraception",
                    "criterion": "contraception agreement",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "female subjects ... use effective methods of contraception ... for at least 27 weeks ... after the last dose of the IP",
                    "criterion": "contraception duration (female)",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 27,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "male subjects ... use effective methods of contraception ... for at least ... 14 weeks ... after the last dose of the IP",
                    "criterion": "contraception duration (male)",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 14,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "**Effective forms of contraception are defined as the following:",
            "criterions": [
                {
                    "exact_snippets": "Effective forms of contraception",
                    "criterion": "contraception",
                    "requirements": [
                        {
                            "requirement_type": "effectiveness",
                            "expected_value": "effective"
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. Hormonal contraceptives (implants, injectables, oral contraceptives, etc.)",
            "criterions": [
                {
                    "exact_snippets": "Hormonal contraceptives (implants, injectables, oral contraceptives, etc.)",
                    "criterion": "hormonal contraceptives",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Intrauterine device or intrauterine system (copper loop, hormone containing intrauterine system)",
            "criterions": [
                {
                    "exact_snippets": "Intrauterine device or intrauterine system (copper loop, hormone containing intrauterine system)",
                    "criterion": "intrauterine device or intrauterine system",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Surgical sterilization (vasectomy, tubal ligation, etc.) of a subject or spouse (or partner)",
            "criterions": [
                {
                    "exact_snippets": "Surgical sterilization (vasectomy, tubal ligation, etc.)",
                    "criterion": "surgical sterilization",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "subject or spouse (or partner)",
                    "criterion": "subject or spouse (or partner)",
                    "requirements": [
                        {
                            "requirement_type": "applicability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Double-barrier method with spermicide (including condom, diaphragm, vaginal sponge, or cervical cap; a male and a female condom must not be used together)",
            "criterions": [
                {
                    "exact_snippets": "Double-barrier method with spermicide (including condom, diaphragm, vaginal sponge, or cervical cap; a male and a female condom must not be used together)",
                    "criterion": "contraceptive method",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "double-barrier method",
                                "spermicide"
                            ]
                        },
                        {
                            "requirement_type": "components",
                            "expected_value": [
                                "condom",
                                "diaphragm",
                                "vaginal sponge",
                                "cervical cap"
                            ]
                        },
                        {
                            "requirement_type": "restriction",
                            "expected_value": "a male and a female condom must not be used together"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Toxicity associated with prior anti-cancer therapy that does not resolve to Grade ≤1 or baseline (with the exceptions of alopecia [any grade], Grade ≤2 neuropathy, and endocrinopathy that is not controlled by hormone replacement therapy)",
            "criterions": [
                {
                    "exact_snippets": "Toxicity associated with prior anti-cancer therapy that does not resolve to Grade ≤1 or baseline",
                    "criterion": "toxicity from prior anti-cancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "Grade"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "alopecia [any grade]",
                    "criterion": "alopecia",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "any grade"
                        }
                    ]
                },
                {
                    "exact_snippets": "Grade ≤2 neuropathy",
                    "criterion": "neuropathy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "Grade"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "endocrinopathy that is not controlled by hormone replacement therapy",
                    "criterion": "endocrinopathy",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "not controlled by hormone replacement therapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of using another investigational product/device within 4 weeks (or 5 half-lives, whichever is shorter) prior to IP administration",
            "criterions": [
                {
                    "exact_snippets": "History of using another investigational product/device within 4 weeks (or 5 half-lives, whichever is shorter) prior to IP administration",
                    "criterion": "use of another investigational product/device",
                    "requirements": [
                        {
                            "requirement_type": "time since last use",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "time since last use",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "half-lives"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Ineligibility or inability to participate in the study at the judgement of the investigator",
            "criterions": [
                {
                    "exact_snippets": "Ineligibility or inability to participate in the study",
                    "criterion": "ability to participate in the study",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}