{
    "info": {
        "nct_id": "NCT06667960",
        "official_title": "A Phase 1/2, Multicenter, Open Label, Dose Escalation & Dose Expansion Study of JK06, a 5T4 Antibody Drug Conjugate, in Patients with Unresectable Locally Advanced or Metastatic Cancer",
        "inclusion_criteria": "* 1. Age ≥ 18 years old. 2. Signed informed consent and willing and able to comply with study procedures and scheduled visits.\n\n  3. For Dose Escalation, patients with histologically diagnosed unresectable, locally advanced, or metastatic solid tumors.\n\n  4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1. 5. Life expectancy ≥ 12 weeks. 6. Measurable disease as per RECIST 1.1 criteria and documented by CT and/or MRI.\n\nNote: lesions treated previously with radiation must demonstrate clear evidence of radiographic progression since the completion of prior radiotherapy and prior to study enrollment.\n\n7. Acceptable laboratory parameters:\n\n* Albumin ≥ 2.8 g/dL.\n* Platelet count ≥ 100, 000.\n* Hemoglobin ≥ 9.0 g/dL.\n* Absolute neutrophil count ≥ 1,500/μL.\n* ALT/AST ≤ 3.0 times ULN.\n\n  - ALT/AST ≤ 5 × ULN for patients with liver metastases.\n* Total bilirubin ≤ 1.5 ULN or ≤ 3 x ULN for patients with Gilbert's disease.\n* Direct bilirubin ≤ 1.5 ULN for patients with total bilirubin > 1.5 ULN.\n* Creatinine ≤ 1.8 mg/dL.\n\n  * Or calculated/measured creatinine clearance > 30 mL/minute. 8. Identification of an archival tumor sample (i.e., tissue block (formalin-fixed paraffin-embedded [FFPE]) or a series of approximately 10-15 slides).\n\n    9. Consent to pre-treatment fresh tumor biopsy for patients enrolled in the back-fill part of Dose Escalation and all eligible patients enrolled in Cohort Expansion.\n\n    10. Women of childbearing potential (WOCBP) not surgically sterilized and between menarche and 1 year post menopause must have a negative serum or urine pregnancy test.\n\n    11. Treated central nervous system (CNS) metastases 12. Must be willing and able to comply with clinic visits and procedures outlined in the study protocol.\n\n    13. Concurrent use of hormones for breast cancer or for non-cancer related conditions (e.g., insulin for diabetes, hormone replacement therapy) is acceptable. Bisphosphonates or RANK-L inhibitors or analogues are permitted for supportive care of patients with bone metastases.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Patients with symptomatic or unstable CNS primary tumor or metastases and/or carcinomatous meningitis. Patients with documented treated CNS metastases stable for at least 4 weeks may be enrolled at the discretion of the investigator.\n2. Major surgery within 6 weeks from treatment initiation.\n3. Clinically significant cardiovascular/vascular disease ≤ 6 months before first dose.\n4. Clinically significant gastrointestinal disorders.\n5. Clinically significant pulmonary compromise requiring supplemental oxygen use.\n6. Grade 2 or greater peripheral neuropathy at time of study entry.\n7. Vaccination with any live virus vaccine within 4 weeks prior to the initiation of study drug administration. Inactivated annual influenza vaccination is allowed.\n8. Known hypersensitivity to JK06 or any excipient.\n9. Second primary invasive malignancy not in remission for ≥ 1 year. Exceptions include non-melanoma skin cancer, cervical carcinoma in situ, resected melanoma in situ, or any malignancy considered to be indolent and never required therapy.\n10. Any serious underlying medical or psychiatric condition that would preclude understanding and rendering of informed consent or impair the ability of the patient to receive or tolerate the planned treatment.\n11. Recent or ongoing serious infection.\n12. Prior systemic anti-cancer treatment:\n\n    * For cytotoxic chemotherapy, small molecule inhibitors, radiation, or similar investigational treatments, ≤ 2 weeks or 5 half-lives, whichever is shorter.\n    * For monoclonal antibodies or similar experimental therapies: ≤ 3 weeks or 5 half-lives, whichever is shorter.\n    * Antibody drug conjugates and radioimmunoconjugates or other similar experimental therapies ≤ 6 weeks or 5 half-lives, whichever is shorter.\n13. Ascites or pleural effusions requiring large volume para- or pleurocentesis within 4 weeks of treatment initiation.\n14. Pregnant or nursing.\n15. Therapeutic anticoagulation for a thromboembolic event that occurred within 3 months of dosing; prophylactic anticoagulation is permitted.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* 1. Age ≥ 18 years old. 2. Signed informed consent and willing and able to comply with study procedures and scheduled visits.",
            "criterions": [
                {
                    "exact_snippets": "Age ≥ 18 years old",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Signed informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "willing and able to comply with study procedures and scheduled visits",
                    "criterion": "compliance with study procedures and scheduled visits",
                    "requirements": [
                        {
                            "requirement_type": "willingness and ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. For Dose Escalation, patients with histologically diagnosed unresectable, locally advanced, or metastatic solid tumors.",
            "criterions": [
                {
                    "exact_snippets": "histologically diagnosed",
                    "criterion": "diagnosis method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": "histological"
                        }
                    ]
                },
                {
                    "exact_snippets": "unresectable",
                    "criterion": "tumor resectability",
                    "requirements": [
                        {
                            "requirement_type": "resectability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "locally advanced",
                    "criterion": "tumor stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "locally advanced"
                        }
                    ]
                },
                {
                    "exact_snippets": "metastatic solid tumors",
                    "criterion": "tumor type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "metastatic solid tumor"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1. 5. Life expectancy ≥ 12 weeks. 6. Measurable disease as per RECIST 1.1 criteria and documented by CT and/or MRI.",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "performance status",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Life expectancy ≥ 12 weeks",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Measurable disease as per RECIST 1.1 criteria and documented by CT and/or MRI",
                    "criterion": "measurable disease",
                    "requirements": [
                        {
                            "requirement_type": "criteria",
                            "expected_value": "RECIST 1.1"
                        },
                        {
                            "requirement_type": "documentation",
                            "expected_value": [
                                "CT",
                                "MRI"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "Note: lesions treated previously with radiation must demonstrate clear evidence of radiographic progression since the completion of prior radiotherapy and prior to study enrollment.",
            "criterions": [
                {
                    "exact_snippets": "lesions treated previously with radiation must demonstrate clear evidence of radiographic progression since the completion of prior radiotherapy",
                    "criterion": "lesions treated previously with radiation",
                    "requirements": [
                        {
                            "requirement_type": "radiographic progression",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Acceptable laboratory parameters:",
            "criterions": [
                {
                    "exact_snippets": "Acceptable laboratory parameters",
                    "criterion": "laboratory parameters",
                    "requirements": [
                        {
                            "requirement_type": "acceptability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Albumin ≥ 2.8 g/dL.",
            "criterions": [
                {
                    "exact_snippets": "Albumin ≥ 2.8 g/dL",
                    "criterion": "albumin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2.8,
                                "unit": "g/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Platelet count ≥ 100, 000.",
            "criterions": [
                {
                    "exact_snippets": "Platelet count ≥ 100, 000.",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": ""
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hemoglobin ≥ 9.0 g/dL.",
            "criterions": [
                {
                    "exact_snippets": "Hemoglobin ≥ 9.0 g/dL",
                    "criterion": "hemoglobin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 9.0,
                                "unit": "g/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Absolute neutrophil count ≥ 1,500/μL.",
            "criterions": [
                {
                    "exact_snippets": "Absolute neutrophil count ≥ 1,500/μL.",
                    "criterion": "absolute neutrophil count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "μL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ALT/AST ≤ 3.0 times ULN.",
            "criterions": [
                {
                    "exact_snippets": "ALT/AST ≤ 3.0 times ULN",
                    "criterion": "ALT/AST levels",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3.0,
                                "unit": "times ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "- ALT/AST ≤ 5 × ULN for patients with liver metastases.",
            "criterions": [
                {
                    "exact_snippets": "ALT/AST ≤ 5 × ULN for patients with liver metastases.",
                    "criterion": "ALT/AST levels",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "× ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Total bilirubin ≤ 1.5 ULN or ≤ 3 x ULN for patients with Gilbert's disease.",
            "criterions": [
                {
                    "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 x ULN for patients with Gilbert's disease",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Gilbert's disease",
                    "criterion": "Gilbert's disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Direct bilirubin ≤ 1.5 ULN for patients with total bilirubin > 1.5 ULN.",
            "criterions": [
                {
                    "exact_snippets": "Direct bilirubin ≤ 1.5 ULN",
                    "criterion": "direct bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "total bilirubin > 1.5 ULN",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.5,
                                "unit": "ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Creatinine ≤ 1.8 mg/dL.",
            "criterions": [
                {
                    "exact_snippets": "Creatinine ≤ 1.8 mg/dL",
                    "criterion": "creatinine level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.8,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Or calculated/measured creatinine clearance > 30 mL/minute. 8. Identification of an archival tumor sample (i.e., tissue block (formalin-fixed paraffin-embedded [FFPE]) or a series of approximately 10-15 slides).",
            "criterions": [
                {
                    "exact_snippets": "calculated/measured creatinine clearance > 30 mL/minute",
                    "criterion": "creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 30,
                                "unit": "mL/minute"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Identification of an archival tumor sample (i.e., tissue block (formalin-fixed paraffin-embedded [FFPE]) or a series of approximately 10-15 slides)",
                    "criterion": "archival tumor sample",
                    "requirements": [
                        {
                            "requirement_type": "identification",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Consent to pre-treatment fresh tumor biopsy for patients enrolled in the back-fill part of Dose Escalation and all eligible patients enrolled in Cohort Expansion.",
            "criterions": [
                {
                    "exact_snippets": "Consent to pre-treatment fresh tumor biopsy",
                    "criterion": "pre-treatment fresh tumor biopsy consent",
                    "requirements": [
                        {
                            "requirement_type": "consent",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Women of childbearing potential (WOCBP) not surgically sterilized and between menarche and 1 year post menopause must have a negative serum or urine pregnancy test.",
            "criterions": [
                {
                    "exact_snippets": "Women of childbearing potential (WOCBP) not surgically sterilized and between menarche and 1 year post menopause",
                    "criterion": "women of childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "surgical sterilization",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "age range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "year post menopause"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "must have a negative serum or urine pregnancy test",
                    "criterion": "pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Treated central nervous system (CNS) metastases 12. Must be willing and able to comply with clinic visits and procedures outlined in the study protocol.",
            "criterions": [
                {
                    "exact_snippets": "Treated central nervous system (CNS) metastases",
                    "criterion": "central nervous system (CNS) metastases",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "treated"
                        }
                    ]
                },
                {
                    "exact_snippets": "Must be willing and able to comply with clinic visits and procedures outlined in the study protocol",
                    "criterion": "compliance with clinic visits and procedures",
                    "requirements": [
                        {
                            "requirement_type": "willingness and ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. Concurrent use of hormones for breast cancer or for non-cancer related conditions (e.g., insulin for diabetes, hormone replacement therapy) is acceptable. Bisphosphonates or RANK-L inhibitors or analogues are permitted for supportive care of patients with bone metastases.",
            "criterions": [
                {
                    "exact_snippets": "Concurrent use of hormones for breast cancer ... is acceptable.",
                    "criterion": "hormone use for breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "acceptability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Concurrent use of hormones ... for non-cancer related conditions (e.g., insulin for diabetes, hormone replacement therapy) is acceptable.",
                    "criterion": "hormone use for non-cancer related conditions",
                    "requirements": [
                        {
                            "requirement_type": "acceptability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Bisphosphonates or RANK-L inhibitors or analogues are permitted for supportive care of patients with bone metastases.",
                    "criterion": "use of bisphosphonates or RANK-L inhibitors or analogues",
                    "requirements": [
                        {
                            "requirement_type": "acceptability",
                            "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. Patients with symptomatic or unstable CNS primary tumor or metastases and/or carcinomatous meningitis. Patients with documented treated CNS metastases stable for at least 4 weeks may be enrolled at the discretion of the investigator.",
            "criterions": [
                {
                    "exact_snippets": "symptomatic or unstable CNS primary tumor",
                    "criterion": "CNS primary tumor",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": "unstable"
                        },
                        {
                            "requirement_type": "symptoms",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "CNS ... metastases",
                    "criterion": "CNS metastases",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": "unstable"
                        },
                        {
                            "requirement_type": "symptoms",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "carcinomatous meningitis",
                    "criterion": "carcinomatous meningitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "documented treated CNS metastases stable for at least 4 weeks",
                    "criterion": "treated CNS metastases",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Major surgery within 6 weeks from treatment initiation.",
            "criterions": [
                {
                    "exact_snippets": "Major surgery within 6 weeks from treatment initiation.",
                    "criterion": "major surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Clinically significant cardiovascular/vascular disease ≤ 6 months before first dose.",
            "criterions": [
                {
                    "exact_snippets": "Clinically significant cardiovascular/vascular disease ≤ 6 months before first dose.",
                    "criterion": "cardiovascular/vascular disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "clinically significant"
                        },
                        {
                            "requirement_type": "time since diagnosis",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Clinically significant gastrointestinal disorders.",
            "criterions": [
                {
                    "exact_snippets": "Clinically significant gastrointestinal disorders",
                    "criterion": "gastrointestinal disorders",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "clinically significant"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Clinically significant pulmonary compromise requiring supplemental oxygen use.",
            "criterions": [
                {
                    "exact_snippets": "Clinically significant pulmonary compromise",
                    "criterion": "pulmonary compromise",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "clinically significant"
                        }
                    ]
                },
                {
                    "exact_snippets": "requiring supplemental oxygen use",
                    "criterion": "supplemental oxygen use",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Grade 2 or greater peripheral neuropathy at time of study entry.",
            "criterions": [
                {
                    "exact_snippets": "Grade 2 or greater peripheral neuropathy",
                    "criterion": "peripheral neuropathy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Vaccination with any live virus vaccine within 4 weeks prior to the initiation of study drug administration. Inactivated annual influenza vaccination is allowed.",
            "criterions": [
                {
                    "exact_snippets": "Vaccination with any live virus vaccine within 4 weeks prior to the initiation of study drug administration.",
                    "criterion": "live virus vaccine",
                    "requirements": [
                        {
                            "requirement_type": "time since vaccination",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Inactivated annual influenza vaccination is allowed.",
                    "criterion": "inactivated annual influenza vaccination",
                    "requirements": [
                        {
                            "requirement_type": "allowance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Known hypersensitivity to JK06 or any excipient.",
            "criterions": [
                {
                    "exact_snippets": "Known hypersensitivity to JK06",
                    "criterion": "hypersensitivity to JK06",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "hypersensitivity to ... any excipient",
                    "criterion": "hypersensitivity to any excipient",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Second primary invasive malignancy not in remission for ≥ 1 year. Exceptions include non-melanoma skin cancer, cervical carcinoma in situ, resected melanoma in situ, or any malignancy considered to be indolent and never required therapy.",
            "criterions": [
                {
                    "exact_snippets": "Second primary invasive malignancy not in remission for ≥ 1 year.",
                    "criterion": "second primary invasive malignancy",
                    "requirements": [
                        {
                            "requirement_type": "remission duration",
                            "expected_value": {
                                "operator": "<",
                                "value": 1,
                                "unit": "year"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Exceptions include non-melanoma skin cancer, cervical carcinoma in situ, resected melanoma in situ, or any malignancy considered to be indolent and never required therapy.",
                    "criterion": "exceptions to second primary invasive malignancy",
                    "requirements": [
                        {
                            "requirement_type": "types",
                            "expected_value": [
                                "non-melanoma skin cancer",
                                "cervical carcinoma in situ",
                                "resected melanoma in situ",
                                "any malignancy considered to be indolent and never required therapy"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Any serious underlying medical or psychiatric condition that would preclude understanding and rendering of informed consent or impair the ability of the patient to receive or tolerate the planned treatment.",
            "criterions": [
                {
                    "exact_snippets": "serious underlying medical or psychiatric condition",
                    "criterion": "underlying medical or psychiatric condition",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        }
                    ]
                },
                {
                    "exact_snippets": "preclude understanding and rendering of informed consent",
                    "criterion": "ability to understand and render informed consent",
                    "requirements": [
                        {
                            "requirement_type": "impairment",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "impair the ability of the patient to receive or tolerate the planned treatment",
                    "criterion": "ability to receive or tolerate the planned treatment",
                    "requirements": [
                        {
                            "requirement_type": "impairment",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Recent or ongoing serious infection.",
            "criterions": [
                {
                    "exact_snippets": "Recent or ongoing serious infection",
                    "criterion": "serious infection",
                    "requirements": [
                        {
                            "requirement_type": "recency",
                            "expected_value": "recent"
                        },
                        {
                            "requirement_type": "status",
                            "expected_value": "ongoing"
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Prior systemic anti-cancer treatment:",
            "criterions": [
                {
                    "exact_snippets": "Prior systemic anti-cancer treatment",
                    "criterion": "systemic anti-cancer treatment",
                    "requirements": [
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* For cytotoxic chemotherapy, small molecule inhibitors, radiation, or similar investigational treatments, ≤ 2 weeks or 5 half-lives, whichever is shorter.",
            "criterions": [
                {
                    "exact_snippets": "cytotoxic chemotherapy, small molecule inhibitors, radiation, or similar investigational treatments, ≤ 2 weeks or 5 half-lives, whichever is shorter.",
                    "criterion": "prior treatment",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "half-lives"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* For monoclonal antibodies or similar experimental therapies: ≤ 3 weeks or 5 half-lives, whichever is shorter.",
            "criterions": [
                {
                    "exact_snippets": "monoclonal antibodies or similar experimental therapies: ≤ 3 weeks or 5 half-lives, whichever is shorter.",
                    "criterion": "washout period for monoclonal antibodies or similar experimental therapies",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "half-lives"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Antibody drug conjugates and radioimmunoconjugates or other similar experimental therapies ≤ 6 weeks or 5 half-lives, whichever is shorter.",
            "criterions": [
                {
                    "exact_snippets": "Antibody drug conjugates and radioimmunoconjugates or other similar experimental therapies ≤ 6 weeks or 5 half-lives, whichever is shorter.",
                    "criterion": "prior experimental therapies",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 6,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "half-lives"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. Ascites or pleural effusions requiring large volume para- or pleurocentesis within 4 weeks of treatment initiation.",
            "criterions": [
                {
                    "exact_snippets": "Ascites",
                    "criterion": "ascites",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "requiring large volume paracentesis within 4 weeks of treatment initiation"
                        }
                    ]
                },
                {
                    "exact_snippets": "pleural effusions",
                    "criterion": "pleural effusions",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "requiring large volume pleurocentesis within 4 weeks of treatment initiation"
                        }
                    ]
                }
            ]
        },
        {
            "line": "14. Pregnant or nursing.",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "nursing",
                    "criterion": "nursing",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "15. Therapeutic anticoagulation for a thromboembolic event that occurred within 3 months of dosing; prophylactic anticoagulation is permitted.",
            "criterions": [
                {
                    "exact_snippets": "Therapeutic anticoagulation for a thromboembolic event that occurred within 3 months of dosing",
                    "criterion": "therapeutic anticoagulation for thromboembolic event",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "prophylactic anticoagulation is permitted",
                    "criterion": "prophylactic anticoagulation",
                    "requirements": [
                        {
                            "requirement_type": "permitted",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}