{
    "info": {
        "nct_id": "NCT05001282",
        "official_title": "Dose Escalation and Expansion Clinical Study to Evaluate the Safety and Efficacy of ELU001 in Subjects Who Have Advanced, Recurrent or Refractory FRα Overexpressing Tumors",
        "inclusion_criteria": "Patients must meet the following criteria to enroll in this study:\n\n* Part 1 Documented diagnosis of ovarian cancer, endometrial cancer, colorectal cancer, gastric cancer, gastroesophageal junction cancer, triple negative breast cancer, non-small cell lung cancer, or cholangiocarcinoma\n* Part 2 Ovarian Cancer or Endometrial Cancer\n* No other meaningful life-prolonging therapy option available\n* Must provide archival tumor tissue or a newly obtained tumor biopsy specimen prior to the first dose of ELU001 for folate receptor alpha (FRα) expression analysis. Previous FRα expression test results may be used in certain circumstances\n* Adequate organ function\n* Measurable disease, or in the absence of measurable disease, non-measurable disease as per Response evaluation criteria in solid tumors (RECIST) v1.1\n* Part 1: Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2; Part 2: ECOG performance status of 0 or 1.\n* Recovered from previous surgeries\n* Agree to highly effective contraception, not to get pregnant, or for men, not father a child during study participation\n\nKey\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "Patients who meet any of the following are not eligible to enroll in this study:\n\n* Clinically significant eye disorders\n* Taken any treatments that use the protein folate receptor alpha or FRα to work\n* Taken any other experimental treatments\n* History of significant cardiac issues or other cancers within 3 years.\n* Significant anemia, significant neutropenia, or significant thrombocytopenia (e.g., not enough platelets in your blood - platelets held stop bleeding in your body)\n* Detectable viral load for HIV (human immunodeficiency virus), hepatitis B or C.\n* If you are pregnant.\n* Part 1: Cannot have active autoimmune diseases such as rheumatoid arthritis, SLE (systemic lupus erythematosus), ulcerative colitis, Crohn's Disease, MS (multiple sclerosis), ankylosing spondylitis, thyroiditis that require treatments that suppress your immune system.\n* Part 1: if your cancer has spread to your brain.\n* Part 2: You can have cancer that has spread to your brain but there are exceptions. The cancer in your brain cannot be causing any symptoms, it cannot be larger than 3 cm, there can be no evidence on a scan that shows your brain tissue has shifted from its expected position inside the skull (called \"herniation\") or be bleeding in the skull or brain itself (called \"hemorrhage\").",
        "miscellaneous_criteria": "Key"
    },
    "inclusion_lines": [
        {
            "line": "* Part 2 Ovarian Cancer or Endometrial Cancer",
            "criterions": [
                {
                    "exact_snippets": "Ovarian Cancer",
                    "criterion": "Ovarian Cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Endometrial Cancer",
                    "criterion": "Endometrial Cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No other meaningful life-prolonging therapy option available",
            "criterions": [
                {
                    "exact_snippets": "No other meaningful life-prolonging therapy option available",
                    "criterion": "life-prolonging therapy option",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Must provide archival tumor tissue or a newly obtained tumor biopsy specimen prior to the first dose of ELU001 for folate receptor alpha (FRα) expression analysis. Previous FRα expression test results may be used in certain circumstances",
            "criterions": [
                {
                    "exact_snippets": "Must provide archival tumor tissue or a newly obtained tumor biopsy specimen",
                    "criterion": "tumor tissue or biopsy specimen",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "folate receptor alpha (FRα) expression analysis",
                    "criterion": "folate receptor alpha (FRα) expression",
                    "requirements": [
                        {
                            "requirement_type": "analysis",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate organ function",
            "criterions": [
                {
                    "exact_snippets": "Adequate organ function",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": "adequate"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Measurable disease, or in the absence of measurable disease, non-measurable disease as per Response evaluation criteria in solid tumors (RECIST) v1.1",
            "criterions": [
                {
                    "exact_snippets": "Measurable disease",
                    "criterion": "disease measurability",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "measurable"
                        }
                    ]
                },
                {
                    "exact_snippets": "absence of measurable disease, non-measurable disease",
                    "criterion": "disease measurability",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "non-measurable"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Part 1: Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2; Part 2: ECOG performance status of 0 or 1.",
            "criterions": [
                {
                    "exact_snippets": "Part 1: Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1",
                                "2"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Part 2: ECOG performance status of 0 or 1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Recovered from previous surgeries",
            "criterions": [
                {
                    "exact_snippets": "Recovered from previous surgeries",
                    "criterion": "recovery from previous surgeries",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "recovered"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Agree to highly effective contraception, not to get pregnant, or for men, not father a child during study participation",
            "criterions": [
                {
                    "exact_snippets": "Agree to highly effective contraception",
                    "criterion": "contraception",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "not to get pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "condition",
                            "expected_value": "not pregnant"
                        }
                    ]
                },
                {
                    "exact_snippets": "for men, not father a child",
                    "criterion": "fathering a child",
                    "requirements": [
                        {
                            "requirement_type": "condition",
                            "expected_value": "not father a child"
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Clinically significant eye disorders",
            "criterions": [
                {
                    "exact_snippets": "Clinically significant eye disorders",
                    "criterion": "eye disorders",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "clinically significant"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Taken any treatments that use the protein folate receptor alpha or FRα to work",
            "criterions": [
                {
                    "exact_snippets": "Taken any treatments that use the protein folate receptor alpha or FRα to work",
                    "criterion": "treatment using folate receptor alpha",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Taken any other experimental treatments",
            "criterions": [
                {
                    "exact_snippets": "Taken any other experimental treatments",
                    "criterion": "experimental treatments",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of significant cardiac issues or other cancers within 3 years.",
            "criterions": [
                {
                    "exact_snippets": "History of significant cardiac issues",
                    "criterion": "cardiac issues",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "significance",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "other cancers within 3 years",
                    "criterion": "other cancers",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Significant anemia, significant neutropenia, or significant thrombocytopenia (e.g., not enough platelets in your blood - platelets held stop bleeding in your body)",
            "criterions": [
                {
                    "exact_snippets": "Significant anemia",
                    "criterion": "anemia",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        }
                    ]
                },
                {
                    "exact_snippets": "significant neutropenia",
                    "criterion": "neutropenia",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        }
                    ]
                },
                {
                    "exact_snippets": "significant thrombocytopenia",
                    "criterion": "thrombocytopenia",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* If you are pregnant.",
            "criterions": [
                {
                    "exact_snippets": "If you are pregnant.",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Part 1: Cannot have active autoimmune diseases such as rheumatoid arthritis, SLE (systemic lupus erythematosus), ulcerative colitis, Crohn's Disease, MS (multiple sclerosis), ankylosing spondylitis, thyroiditis that require treatments that suppress your immune system.",
            "criterions": [
                {
                    "exact_snippets": "Cannot have active autoimmune diseases such as rheumatoid arthritis, SLE (systemic lupus erythematosus), ulcerative colitis, Crohn's Disease, MS (multiple sclerosis), ankylosing spondylitis, thyroiditis",
                    "criterion": "active autoimmune diseases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "require treatments that suppress your immune system",
                    "criterion": "treatments that suppress immune system",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Part 1: if your cancer has spread to your brain.",
            "criterions": [
                {
                    "exact_snippets": "cancer has spread to your brain",
                    "criterion": "cancer metastasis to brain",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "Patients must meet the following criteria to enroll in this study:",
            "criterions": []
        },
        {
            "line": "* Part 1 Documented diagnosis of ovarian cancer, endometrial cancer, colorectal cancer, gastric cancer, gastroesophageal junction cancer, triple negative breast cancer, non-small cell lung cancer, or cholangiocarcinoma",
            "criterions": [
                {
                    "exact_snippets": "Documented diagnosis of ovarian cancer",
                    "criterion": "ovarian cancer",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Documented diagnosis of endometrial cancer",
                    "criterion": "endometrial cancer",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Documented diagnosis of colorectal cancer",
                    "criterion": "colorectal cancer",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Documented diagnosis of gastric cancer",
                    "criterion": "gastric cancer",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Documented diagnosis of gastroesophageal junction cancer",
                    "criterion": "gastroesophageal junction cancer",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Documented diagnosis of triple negative breast cancer",
                    "criterion": "triple negative breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Documented diagnosis of non-small cell lung cancer",
                    "criterion": "non-small cell lung cancer",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Documented diagnosis of cholangiocarcinoma",
                    "criterion": "cholangiocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Key",
            "criterions": [
                {
                    "exact_snippets": "Tissue from tumor must be available",
                    "criterion": "tumor tissue",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Tissue from tumor ... > 2 cm in diameter.",
                    "criterion": "tumor tissue",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "cm"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "failed_exclusion": [
        {
            "line": "Patients who meet any of the following are not eligible to enroll in this study:",
            "criterions": []
        },
        {
            "line": "* Detectable viral load for HIV (human immunodeficiency virus), hepatitis B or C.",
            "criterions": [
                {
                    "exact_snippets": "Detectable viral load for HIV (human immunodeficiency virus)",
                    "criterion": "HIV viral load",
                    "requirements": [
                        {
                            "requirement_type": "detectability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Detectable viral load for hepatitis B",
                    "criterion": "hepatitis B viral load",
                    "requirements": [
                        {
                            "requirement_type": "detectability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Detectable viral load for ... hepatitis C",
                    "criterion": "hepatitis C viral load",
                    "requirements": [
                        {
                            "requirement_type": "detectability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Part 2: You can have cancer that has spread to your brain but there are exceptions. The cancer in your brain cannot be causing any symptoms, it cannot be larger than 3 cm, there can be no evidence on a scan that shows your brain tissue has shifted from its expected position inside the skull (called \"herniation\") or be bleeding in the skull or brain itself (called \"hemorrhage\").",
            "criterions": [
                {
                    "exact_snippets": "cancer that has spread to your brain",
                    "criterion": "cancer metastasis to brain",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "cancer in your brain cannot be causing any symptoms",
                    "criterion": "symptoms from brain metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "cancer in your brain cannot be larger than 3 cm",
                    "criterion": "size of brain metastasis",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "cm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "no evidence on a scan that shows your brain tissue has shifted from its expected position inside the skull (called \"herniation\")",
                    "criterion": "brain tissue herniation",
                    "requirements": [
                        {
                            "requirement_type": "evidence on scan",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "be bleeding in the skull or brain itself (called \"hemorrhage\")",
                    "criterion": "intracranial hemorrhage",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "failed_miscellaneous": [
        {
            "line": "Key",
            "criterions": [
                {
                    "exact_snippets": "Tissue from tumor must be available",
                    "criterion": "tumor tissue",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Tissue from tumor ... > 2 cm in diameter.",
                    "criterion": "tumor tissue",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "cm"
                            }
                        }
                    ]
                }
            ]
        }
    ]
}