{
    "info": {
        "nct_id": "NCT04640480",
        "official_title": "A Phase I, Open-Label, Dose-finding Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Intravenously Infused SNB-101(as SN-38) in Patients With Advanced Solid Tumors",
        "inclusion_criteria": "* Patients with a histologically or cytologically confirmed, locally advanced or metastatic disease, has progressed after systemic standard of care treatment for advanced disease and is not suitable for complete surgical resection.\n* Patients with measurable or evaluable disease consistent with Response Evaluation Criteria in Solid Tumors version 1.1.\n* Patients ambulatory with an Eastern Cooperative Oncology Group performance score of 0 or 1.\n* Patients with adequate hematological, renal, and liver function(CTCAE V5.0 grade 1 or lower).\n* Patients with the life expectancy of 3 months or longer.\nHealthy volunteers allowed\nMust have minimum age of 19 Years",
        "exclusion_criteria": "* Patients homozygous for UGT1A1*28 or UGT1A1*6 alleles.\n* Patients known or suspected intolerance or hypersensitivity to main ingredient or any of the excipients of SNB-101.\n* Patients with unintentional weight loss >10% within 3 months prior to screening.\n* Patients who are on dialysis.\n* Patients who are positive for HIVs.\n* Patients with a QT interval with Fridericia's correction outside of normal.\n* Patients with intestinal palsy or bowel obstruction.\n* Patients with chronic inflammatory bowel disease.\n* Patients who may require administration of neuromuscular blockers, peripheral muscle relaxants, etc. during the study.\n* Patients who may require lapatinib during the study.\n* Patients who may require attenuated vaccine during the study.\n* Patients who are taking any medication that in the judgement of the investigator could have an effect on the action of SNB-101.\n* Patients unable to participate in the study as judged by the investigator.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Patients with a histologically or cytologically confirmed, locally advanced or metastatic disease, has progressed after systemic standard of care treatment for advanced disease and is not suitable for complete surgical resection.",
            "criterions": [
                {
                    "exact_snippets": "histologically or cytologically confirmed",
                    "criterion": "disease confirmation",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "locally advanced or metastatic disease",
                    "criterion": "disease stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "locally advanced",
                                "metastatic"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "has progressed after systemic standard of care treatment for advanced disease",
                    "criterion": "disease progression",
                    "requirements": [
                        {
                            "requirement_type": "progression",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "is not suitable for complete surgical resection",
                    "criterion": "surgical resection suitability",
                    "requirements": [
                        {
                            "requirement_type": "suitability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with measurable or evaluable disease consistent with Response Evaluation Criteria in Solid Tumors version 1.1.",
            "criterions": [
                {
                    "exact_snippets": "measurable or evaluable disease",
                    "criterion": "disease measurability",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "measurable",
                                "evaluable"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "consistent with Response Evaluation Criteria in Solid Tumors version 1.1",
                    "criterion": "consistency with RECIST 1.1",
                    "requirements": [
                        {
                            "requirement_type": "consistency",
                            "expected_value": "RECIST 1.1"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients ambulatory with an Eastern Cooperative Oncology Group performance score of 0 or 1.",
            "criterions": [
                {
                    "exact_snippets": "ambulatory",
                    "criterion": "ambulatory status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group performance score of 0 or 1",
                    "criterion": "ECOG performance score",
                    "requirements": [
                        {
                            "requirement_type": "score",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with the life expectancy of 3 months or longer.",
            "criterions": [
                {
                    "exact_snippets": "life expectancy of 3 months or longer",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 19 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 19 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 19,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Patients homozygous for UGT1A1*28 or UGT1A1*6 alleles.",
            "criterions": [
                {
                    "exact_snippets": "Patients homozygous for UGT1A1*28",
                    "criterion": "UGT1A1*28 allele",
                    "requirements": [
                        {
                            "requirement_type": "homozygosity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients homozygous for ... UGT1A1*6 alleles",
                    "criterion": "UGT1A1*6 allele",
                    "requirements": [
                        {
                            "requirement_type": "homozygosity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients known or suspected intolerance or hypersensitivity to main ingredient or any of the excipients of SNB-101.",
            "criterions": [
                {
                    "exact_snippets": "intolerance or hypersensitivity to main ingredient",
                    "criterion": "intolerance or hypersensitivity to main ingredient",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "intolerance or hypersensitivity to ... any of the excipients of SNB-101",
                    "criterion": "intolerance or hypersensitivity to excipients of SNB-101",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with unintentional weight loss >10% within 3 months prior to screening.",
            "criterions": [
                {
                    "exact_snippets": "unintentional weight loss >10% within 3 months prior to screening",
                    "criterion": "unintentional weight loss",
                    "requirements": [
                        {
                            "requirement_type": "percentage",
                            "expected_value": {
                                "operator": ">",
                                "value": 10,
                                "unit": "%"
                            }
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 3 months prior to screening"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who are on dialysis.",
            "criterions": [
                {
                    "exact_snippets": "Patients who are on dialysis.",
                    "criterion": "dialysis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who are positive for HIVs.",
            "criterions": [
                {
                    "exact_snippets": "positive for HIVs",
                    "criterion": "HIV status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with a QT interval with Fridericia's correction outside of normal.",
            "criterions": [
                {
                    "exact_snippets": "QT interval with Fridericia's correction outside of normal",
                    "criterion": "QT interval with Fridericia's correction",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": "outside of normal"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with intestinal palsy or bowel obstruction.",
            "criterions": [
                {
                    "exact_snippets": "Patients with intestinal palsy",
                    "criterion": "intestinal palsy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "bowel obstruction",
                    "criterion": "bowel obstruction",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with chronic inflammatory bowel disease.",
            "criterions": [
                {
                    "exact_snippets": "chronic inflammatory bowel disease",
                    "criterion": "chronic inflammatory bowel disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who may require administration of neuromuscular blockers, peripheral muscle relaxants, etc. during the study.",
            "criterions": [
                {
                    "exact_snippets": "Patients who may require administration of neuromuscular blockers",
                    "criterion": "requirement for neuromuscular blockers",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients who may require administration of ... peripheral muscle relaxants",
                    "criterion": "requirement for peripheral muscle relaxants",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who may require lapatinib during the study.",
            "criterions": [
                {
                    "exact_snippets": "Patients who may require lapatinib during the study.",
                    "criterion": "lapatinib requirement",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who may require attenuated vaccine during the study.",
            "criterions": [
                {
                    "exact_snippets": "Patients who may require attenuated vaccine during the study.",
                    "criterion": "attenuated vaccine requirement",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who are taking any medication that in the judgement of the investigator could have an effect on the action of SNB-101.",
            "criterions": [
                {
                    "exact_snippets": "Patients who are taking any medication",
                    "criterion": "medication use",
                    "requirements": [
                        {
                            "requirement_type": "effect on SNB-101",
                            "expected_value": "could have an effect"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients unable to participate in the study as judged by the investigator.",
            "criterions": [
                {
                    "exact_snippets": "Patients unable to participate in the study as judged by the investigator.",
                    "criterion": "ability to participate",
                    "requirements": [
                        {
                            "requirement_type": "judgment",
                            "expected_value": "investigator's discretion"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "* Patients with adequate hematological, renal, and liver function(CTCAE V5.0 grade 1 or lower).",
            "criterions": [
                {
                    "exact_snippets": "adequate hematological ... (CTCAE V5.0 grade 1 or lower)",
                    "criterion": "hematological function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": "CTCAE V5.0 grade 1 or lower"
                        }
                    ]
                },
                {
                    "exact_snippets": "adequate ... renal function(CTCAE V5.0 grade 1 or lower)",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": "CTCAE V5.0 grade 1 or lower"
                        }
                    ]
                },
                {
                    "exact_snippets": "adequate ... liver function(CTCAE V5.0 grade 1 or lower)",
                    "criterion": "liver function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": "CTCAE V5.0 grade 1 or lower"
                        }
                    ]
                }
            ]
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}