{
    "info": {
        "nct_id": "NCT05717348",
        "official_title": "An Open-label, Multicenter, Dose-escalation and Cohort Expansion Phase 1 Clinical Study of ES014 Administered in Patients Locally Advanced or Metastatic Solid Tumours",
        "inclusion_criteria": "* 1. Unresectable locally advanced or metastatic solid tumour diagnosed by pathology or cytology and which meets the criteria of 1) disease progression has occurred despite receiving standard treatment and no other standard treatment is available; or 2) standard treatment has been proven to be ineffective, intolerant or considered unsuitable.\n\n  2. Provide tumor tissue samples.\n\n  3. At least one measurable lesion per RECIST v1.1.\n\n  4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1. Part 1: ECOG PS 0-1. Part 2: ECOG PS 0-2.\n\n  5. Life expectancy of at least 12 weeks.\n\n  6. Adequate hematologic, hepatic, renal and coagulation functions per protocol.\n\n  7. Male and female subjects of childbearing potential must be willing to completely abstain or agree to use a highly effective method of contraception.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* 1. Any prior therapy targeting CD39, CD73, adenosine A2A receptor, or TGF-β.\n\n  2. Receipt of any investigational agents or devices within 4 weeks prior to the first dose of study drug.\n\n  3. Prior treatment with the following therapies: 1) Anticancer therapy within 30 days or 5 half-lives of the drug prior to the first dose of study drug. At least 14 days must have elapsed between the last dose of prior anticancer agent and the first dose of study drug is administered with certain exceptions. 2) A wash out of at least 2 weeks before the start of study drug for radiation to the extremities and 4 weeks for radiation to the chest, brain, or visceral organs is required.\n\n  4. Prior allogeneic or autologous bone marrow transplantation or solid organ transplantation.\n\n  5. Toxicity from previous anticancer treatment per protocol.\n\n  6. Treatment with systemic immunosuppressive medications within 4 weeks prior to the first dose of study drug.\n\n  7. Subjects who received transfusion of blood products (including platelets or red blood cells), G-CSF, GM-CSF, recombinant erythropoietin, or recombinant thrombopoietin within 14 days prior to the first dose of study treatment.\n\n  8. Major surgery within 4 weeks prior to the first dose of study treatment.\n\n  9. Live vaccine therapies within 4 weeks prior to the first dose of study treatment.\n\n  10. Recent history of allergen desensitization therapy within 4 weeks prior to the first dose of study treatment.\n\n  11. Known allergies to CHO-produced antibodies, which in the opinion of the Investigator suggests an increased potential for an adverse hypersensitivity to ES014.\n\n  12. Invasive malignancy or history of invasive malignancy other than disease under study within the last two years per protocol.\n\n  13. CNS metastases.\n\n  14. Active autoimmune disease or documented history of autoimmune disease that required systemic steroids or other immunosuppressive medications per protocol.\n\n  15. Active interstitial lung disease (ILD) or pneumonitis or a history of ILD or pneumonitis requiring treatment with steroids or other immunosuppressive medications.\n\n  16. Active infection requiring systemic therapy, known human immunodeficiency virus (HIV) infection, or positive test for hepatitis B active infection (HBsAg) or hepatitis C active infection (hepatitis C antibody).\n\n  17. Current active liver or biliary disease with certain exceptions.\n\n  18. History or evidence of cardiac abnormalities per protocol.\n\n  19. History of bleeding tendency or a recent major bleeding event which, in the opinion of the investigator, indicates that the subject is at high risk of receiving study treatment.\n\n  20. Pregnant or nursing females.\n\n  21. Any known, documented, or suspected history of substance abuse that would preclude subject from participation with certain exceptions.\n\n  22. Any other disease or clinically significant abnormality in a laboratory parameter, including serious medical or psychiatric disease/condition, that in the opinion of the investigator may compromise the safety of the subject or the integrity of the study, interfere with the subject's participation in the trial or affect the purpose of the trial.\n\n  23. Those involved in the design and/or implementation of the study.\n\n  24. Those deemed by the investigator to be unable to comply with the steps, limitations and requirements of the study.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* 1. Unresectable locally advanced or metastatic solid tumour diagnosed by pathology or cytology and which meets the criteria of 1) disease progression has occurred despite receiving standard treatment and no other standard treatment is available; or 2) standard treatment has been proven to be ineffective, intolerant or considered unsuitable.",
            "criterions": [
                {
                    "exact_snippets": "Unresectable locally advanced or metastatic solid tumour diagnosed by pathology or cytology",
                    "criterion": "solid tumour",
                    "requirements": [
                        {
                            "requirement_type": "resectability",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "locally advanced",
                                "metastatic"
                            ]
                        },
                        {
                            "requirement_type": "diagnosis method",
                            "expected_value": [
                                "pathology",
                                "cytology"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "disease progression has occurred despite receiving standard treatment",
                    "criterion": "disease progression",
                    "requirements": [
                        {
                            "requirement_type": "treatment response",
                            "expected_value": "progression despite standard treatment"
                        }
                    ]
                },
                {
                    "exact_snippets": "no other standard treatment is available",
                    "criterion": "availability of standard treatment",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "standard treatment has been proven to be ineffective, intolerant or considered unsuitable",
                    "criterion": "standard treatment",
                    "requirements": [
                        {
                            "requirement_type": "effectiveness",
                            "expected_value": "ineffective"
                        },
                        {
                            "requirement_type": "tolerance",
                            "expected_value": "intolerant"
                        },
                        {
                            "requirement_type": "suitability",
                            "expected_value": "unsuitable"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Provide tumor tissue samples.",
            "criterions": [
                {
                    "exact_snippets": "tumor tissue samples",
                    "criterion": "tumor tissue samples",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. At least one measurable lesion per RECIST v1.1.",
            "criterions": [
                {
                    "exact_snippets": "At least one measurable lesion per RECIST v1.1.",
                    "criterion": "measurable lesion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "lesion"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1. Part 1: ECOG PS 0-1. Part 2: ECOG PS 0-2.",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1. Part 1: ECOG PS 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"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Part 2: ECOG PS 0-2.",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. 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": "6. Adequate hematologic, hepatic, renal and coagulation functions per protocol.",
            "criterions": [
                {
                    "exact_snippets": "Adequate hematologic ... functions per protocol.",
                    "criterion": "hematologic function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": "per protocol"
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate ... hepatic ... functions per protocol.",
                    "criterion": "hepatic function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": "per protocol"
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate ... renal ... functions per protocol.",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": "per protocol"
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate ... coagulation functions per protocol.",
                    "criterion": "coagulation function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": "per protocol"
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Male and female subjects of childbearing potential must be willing to completely abstain or agree to use a highly effective method of contraception.",
            "criterions": [
                {
                    "exact_snippets": "Male and female subjects of childbearing potential",
                    "criterion": "childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "willing to completely abstain or agree to use a highly effective method of contraception",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "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": "* 1. Any prior therapy targeting CD39, CD73, adenosine A2A receptor, or TGF-β.",
            "criterions": [
                {
                    "exact_snippets": "prior therapy targeting CD39",
                    "criterion": "prior therapy",
                    "requirements": [
                        {
                            "requirement_type": "target",
                            "expected_value": "CD39"
                        }
                    ]
                },
                {
                    "exact_snippets": "prior therapy targeting ... CD73",
                    "criterion": "prior therapy",
                    "requirements": [
                        {
                            "requirement_type": "target",
                            "expected_value": "CD73"
                        }
                    ]
                },
                {
                    "exact_snippets": "prior therapy targeting ... adenosine A2A receptor",
                    "criterion": "prior therapy",
                    "requirements": [
                        {
                            "requirement_type": "target",
                            "expected_value": "adenosine A2A receptor"
                        }
                    ]
                },
                {
                    "exact_snippets": "prior therapy targeting ... TGF-β",
                    "criterion": "prior therapy",
                    "requirements": [
                        {
                            "requirement_type": "target",
                            "expected_value": "TGF-β"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Receipt of any investigational agents or devices within 4 weeks prior to the first dose of study drug.",
            "criterions": [
                {
                    "exact_snippets": "Receipt of any investigational agents or devices within 4 weeks prior to the first dose of study drug.",
                    "criterion": "investigational agents or devices",
                    "requirements": [
                        {
                            "requirement_type": "receipt",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Prior treatment with the following therapies: 1) Anticancer therapy within 30 days or 5 half-lives of the drug prior to the first dose of study drug. At least 14 days must have elapsed between the last dose of prior anticancer agent and the first dose of study drug is administered with certain exceptions. 2) A wash out of at least 2 weeks before the start of study drug for radiation to the extremities and 4 weeks for radiation to the chest, brain, or visceral organs is required.",
            "criterions": [
                {
                    "exact_snippets": "Prior treatment with the following therapies: 1) Anticancer therapy within 30 days or 5 half-lives of the drug prior to the first dose of study drug.",
                    "criterion": "prior anticancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last dose",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 30,
                                        "unit": "days"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "time since last dose",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "half-lives"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "At least 14 days must have elapsed between the last dose of prior anticancer agent and the first dose of study drug is administered with certain exceptions.",
                    "criterion": "time elapsed since last anticancer agent",
                    "requirements": [
                        {
                            "requirement_type": "time elapsed",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 14,
                                        "unit": "days"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "A wash out of at least 2 weeks before the start of study drug for radiation to the extremities",
                    "criterion": "wash out period for radiation to extremities",
                    "requirements": [
                        {
                            "requirement_type": "time elapsed",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 2,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "A wash out of at least ... 4 weeks for radiation to the chest, brain, or visceral organs is required.",
                    "criterion": "wash out period for radiation to chest, brain, or visceral organs",
                    "requirements": [
                        {
                            "requirement_type": "time elapsed",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Prior allogeneic or autologous bone marrow transplantation or solid organ transplantation.",
            "criterions": [
                {
                    "exact_snippets": "Prior allogeneic or autologous bone marrow transplantation",
                    "criterion": "bone marrow transplantation",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "allogeneic",
                                "autologous"
                            ]
                        },
                        {
                            "requirement_type": "temporal",
                            "expected_value": "prior"
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior ... solid organ transplantation",
                    "criterion": "solid organ transplantation",
                    "requirements": [
                        {
                            "requirement_type": "temporal",
                            "expected_value": "prior"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Toxicity from previous anticancer treatment per protocol.",
            "criterions": [
                {
                    "exact_snippets": "Toxicity from previous anticancer treatment",
                    "criterion": "toxicity from previous anticancer treatment",
                    "requirements": [
                        {
                            "requirement_type": "per protocol",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Treatment with systemic immunosuppressive medications within 4 weeks prior to the first dose of study drug.",
            "criterions": [
                {
                    "exact_snippets": "Treatment with systemic immunosuppressive medications within 4 weeks prior to the first dose of study drug.",
                    "criterion": "systemic immunosuppressive medications",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Subjects who received transfusion of blood products (including platelets or red blood cells), G-CSF, GM-CSF, recombinant erythropoietin, or recombinant thrombopoietin within 14 days prior to the first dose of study treatment.",
            "criterions": [
                {
                    "exact_snippets": "transfusion of blood products (including platelets or red blood cells)",
                    "criterion": "transfusion of blood products",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 14,
                                "unit": "days prior to the first dose of study treatment"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "G-CSF",
                    "criterion": "G-CSF administration",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 14,
                                "unit": "days prior to the first dose of study treatment"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "GM-CSF",
                    "criterion": "GM-CSF administration",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 14,
                                "unit": "days prior to the first dose of study treatment"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "recombinant erythropoietin",
                    "criterion": "recombinant erythropoietin administration",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 14,
                                "unit": "days prior to the first dose of study treatment"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "recombinant thrombopoietin",
                    "criterion": "recombinant thrombopoietin administration",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 14,
                                "unit": "days prior to the first dose of study treatment"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Major surgery within 4 weeks prior to the first dose of study treatment.",
            "criterions": [
                {
                    "exact_snippets": "Major surgery within 4 weeks prior to the first dose of study treatment.",
                    "criterion": "major surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Live vaccine therapies within 4 weeks prior to the first dose of study treatment.",
            "criterions": [
                {
                    "exact_snippets": "Live vaccine therapies within 4 weeks prior to the first dose of study treatment.",
                    "criterion": "live vaccine therapies",
                    "requirements": [
                        {
                            "requirement_type": "time since administration",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Recent history of allergen desensitization therapy within 4 weeks prior to the first dose of study treatment.",
            "criterions": [
                {
                    "exact_snippets": "Recent history of allergen desensitization therapy within 4 weeks prior to the first dose of study treatment.",
                    "criterion": "allergen desensitization therapy",
                    "requirements": [
                        {
                            "requirement_type": "recency",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Known allergies to CHO-produced antibodies, which in the opinion of the Investigator suggests an increased potential for an adverse hypersensitivity to ES014.",
            "criterions": [
                {
                    "exact_snippets": "Known allergies to CHO-produced antibodies",
                    "criterion": "allergies to CHO-produced antibodies",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "increased potential for an adverse hypersensitivity to ES014",
                    "criterion": "potential for adverse hypersensitivity to ES014",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "increased"
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Invasive malignancy or history of invasive malignancy other than disease under study within the last two years per protocol.",
            "criterions": [
                {
                    "exact_snippets": "Invasive malignancy",
                    "criterion": "invasive malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "history of invasive malignancy other than disease under study within the last two years",
                    "criterion": "history of invasive malignancy",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. CNS metastases.",
            "criterions": [
                {
                    "exact_snippets": "CNS metastases",
                    "criterion": "CNS metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "14. Active autoimmune disease or documented history of autoimmune disease that required systemic steroids or other immunosuppressive medications per protocol.",
            "criterions": [
                {
                    "exact_snippets": "Active autoimmune disease",
                    "criterion": "autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "active"
                        }
                    ]
                },
                {
                    "exact_snippets": "documented history of autoimmune disease",
                    "criterion": "autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "required systemic steroids or other immunosuppressive medications",
                    "criterion": "autoimmune disease treatment",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": [
                                "systemic steroids",
                                "immunosuppressive medications"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "15. Active interstitial lung disease (ILD) or pneumonitis or a history of ILD or pneumonitis requiring treatment with steroids or other immunosuppressive medications.",
            "criterions": [
                {
                    "exact_snippets": "Active interstitial lung disease (ILD)",
                    "criterion": "interstitial lung disease (ILD)",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    ]
                },
                {
                    "exact_snippets": "Active ... pneumonitis",
                    "criterion": "pneumonitis",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    ]
                },
                {
                    "exact_snippets": "a history of ILD",
                    "criterion": "interstitial lung disease (ILD)",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "a history of ... pneumonitis",
                    "criterion": "pneumonitis",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "requiring treatment with steroids or other immunosuppressive medications",
                    "criterion": "treatment with steroids or other immunosuppressive medications",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "16. Active infection requiring systemic therapy, known human immunodeficiency virus (HIV) infection, or positive test for hepatitis B active infection (HBsAg) or hepatitis C active infection (hepatitis C antibody).",
            "criterions": [
                {
                    "exact_snippets": "Active infection requiring systemic therapy",
                    "criterion": "active infection",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "systemic therapy"
                        }
                    ]
                },
                {
                    "exact_snippets": "known human immunodeficiency virus (HIV) infection",
                    "criterion": "HIV infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "positive test for hepatitis B active infection (HBsAg)",
                    "criterion": "hepatitis B active infection",
                    "requirements": [
                        {
                            "requirement_type": "test result",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "positive test for ... hepatitis C active infection (hepatitis C antibody)",
                    "criterion": "hepatitis C active infection",
                    "requirements": [
                        {
                            "requirement_type": "test result",
                            "expected_value": "positive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "17. Current active liver or biliary disease with certain exceptions.",
            "criterions": [
                {
                    "exact_snippets": "Current active liver or biliary disease",
                    "criterion": "liver or biliary disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    ]
                }
            ]
        },
        {
            "line": "18. History or evidence of cardiac abnormalities per protocol.",
            "criterions": [
                {
                    "exact_snippets": "History or evidence of cardiac abnormalities",
                    "criterion": "cardiac abnormalities",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "19. History of bleeding tendency or a recent major bleeding event which, in the opinion of the investigator, indicates that the subject is at high risk of receiving study treatment.",
            "criterions": [
                {
                    "exact_snippets": "History of bleeding tendency",
                    "criterion": "bleeding tendency",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "recent major bleeding event",
                    "criterion": "major bleeding event",
                    "requirements": [
                        {
                            "requirement_type": "recency",
                            "expected_value": "recent"
                        }
                    ]
                },
                {
                    "exact_snippets": "in the opinion of the investigator, indicates that the subject is at high risk of receiving study treatment",
                    "criterion": "risk of receiving study treatment",
                    "requirements": [
                        {
                            "requirement_type": "risk assessment",
                            "expected_value": "high"
                        }
                    ]
                }
            ]
        },
        {
            "line": "20. Pregnant or nursing females.",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "nursing females",
                    "criterion": "nursing",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "21. Any known, documented, or suspected history of substance abuse that would preclude subject from participation with certain exceptions.",
            "criterions": [
                {
                    "exact_snippets": "Any known, documented, or suspected history of substance abuse",
                    "criterion": "substance abuse history",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "22. Any other disease or clinically significant abnormality in a laboratory parameter, including serious medical or psychiatric disease/condition, that in the opinion of the investigator may compromise the safety of the subject or the integrity of the study, interfere with the subject's participation in the trial or affect the purpose of the trial.",
            "criterions": [
                {
                    "exact_snippets": "Any other disease",
                    "criterion": "other disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "clinically significant abnormality in a laboratory parameter",
                    "criterion": "clinically significant abnormality in a laboratory parameter",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "serious medical or psychiatric disease/condition",
                    "criterion": "serious medical or psychiatric disease/condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "23. Those involved in the design and/or implementation of the study.",
            "criterions": [
                {
                    "exact_snippets": "involved in the design and/or implementation of the study",
                    "criterion": "involvement in study design/implementation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "24. Those deemed by the investigator to be unable to comply with the steps, limitations and requirements of the study.",
            "criterions": [
                {
                    "exact_snippets": "unable to comply with the steps, limitations and requirements of the study",
                    "criterion": "compliance with study protocol",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}