{
    "info": {
        "nct_id": "NCT05156866",
        "official_title": "A Phase 1, First in Human, Dose-Escalation Study of TORL-2-307-ADC in Participants With Advanced Cancer",
        "inclusion_criteria": "* Advanced solid tumor\n* Measurable disease, per RECIST v1.1\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1\n* Adequate organ function\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Has not recovered [recovery is defined as NCI CTCAE, version 5.0, grade ≤1] from the acute toxicities of previous therapy, except treatment-related alopecia or laboratory abnormalities otherwise meeting eligibility requirements\n* Received prior chemotherapeutic, investigational, or other therapies for the treatment of cancer within 14 days with small molecule and within 28 days with biologic before the first dose of TORL-2-307-ADC\n* Progressive or symptomatic brain metastases\n* Serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection\n* History of significant cardiac disease\n* History of myelodysplastic syndrome (MDS) or AML\n* History of another cancer within 3 years before Day 1 of study treatment, with the exception of basal or squamous cell carcinoma of the skin that has been definitively treated. A history of other malignancies with a low risk of recurrence, including appropriately treated ductal carcinoma in situ (DCIS) of the breast and prostate cancer with a Gleason score less than or equal to 6, are also not excluded\n* If female, is pregnant or breastfeeding",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "* Advanced solid tumor",
                "criterions": [
                    {
                        "exact_snippets": "Advanced solid tumor",
                        "criterion": "solid tumor",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": "advanced"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Advanced solid tumor",
                        "criterion": "solid tumor",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": "advanced"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Measurable disease, per RECIST v1.1",
                "criterions": [
                    {
                        "exact_snippets": "Measurable disease, per RECIST v1.1",
                        "criterion": "measurable disease",
                        "requirement": {
                            "requirement_type": "measurement standard",
                            "expected_value": "RECIST v1.1"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Measurable disease, per RECIST v1.1",
                        "criterion": "measurable disease",
                        "requirement": {
                            "requirement_type": "measurement standard",
                            "expected_value": "RECIST v1.1"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Eastern Cooperative Oncology Group (ECOG) performance status 0-1",
                "criterions": [
                    {
                        "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status 0-1",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status 0-1",
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                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Adequate organ function",
                "criterions": [
                    {
                        "exact_snippets": "Adequate organ function",
                        "criterion": "organ function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Adequate organ function",
                        "criterion": "organ function",
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                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Healthy volunteers allowed",
                "criterions": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
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                            "expected_value": "healthy"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have minimum age of 18 Years",
                "criterions": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "* Has not recovered [recovery is defined as NCI CTCAE, version 5.0, grade ≤1] from the acute toxicities of previous therapy, except treatment-related alopecia or laboratory abnormalities otherwise meeting eligibility requirements",
                "criterions": [
                    {
                        "exact_snippets": "Has not recovered ... from the acute toxicities of previous therapy",
                        "criterion": "recovery from acute toxicities of previous therapy",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "NCI CTCAE grade"
                            }
                        }
                    },
                    {
                        "exact_snippets": "treatment-related alopecia",
                        "criterion": "treatment-related alopecia",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "laboratory abnormalities otherwise meeting eligibility requirements",
                        "criterion": "laboratory abnormalities",
                        "requirement": {
                            "requirement_type": "eligibility",
                            "expected_value": "otherwise meeting eligibility requirements"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
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                            "and_criteria": [
                                {
                                    "exact_snippets": "Has not recovered ... from the acute toxicities of previous therapy",
                                    "criterion": "recovery from acute toxicities of previous therapy",
                                    "requirement": {
                                        "requirement_type": "severity",
                                        "expected_value": {
                                            "operator": "<=",
                                            "value": 1,
                                            "unit": "NCI CTCAE grade"
                                        }
                                    }
                                },
                                {
                                    "not_criteria": {
                                        "exact_snippets": "treatment-related alopecia",
                                        "criterion": "treatment-related alopecia",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    }
                                },
                                {
                                    "not_criteria": {
                                        "exact_snippets": "laboratory abnormalities otherwise meeting eligibility requirements",
                                        "criterion": "laboratory abnormalities",
                                        "requirement": {
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                                            "expected_value": "otherwise meeting eligibility requirements"
                                        }
                                    }
                                }
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Received prior chemotherapeutic, investigational, or other therapies for the treatment of cancer within 14 days with small molecule and within 28 days with biologic before the first dose of TORL-2-307-ADC",
                "criterions": [
                    {
                        "exact_snippets": "Received prior chemotherapeutic, investigational, or other therapies for the treatment of cancer within 14 days with small molecule",
                        "criterion": "prior small molecule therapy",
                        "requirement": {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Received prior chemotherapeutic, investigational, or other therapies for the treatment of cancer ... within 28 days with biologic",
                        "criterion": "prior biologic therapy",
                        "requirement": {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
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                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Received prior chemotherapeutic, investigational, or other therapies for the treatment of cancer within 14 days with small molecule",
                                "criterion": "prior small molecule therapy",
                                "requirement": {
                                    "requirement_type": "time since last treatment",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 14,
                                        "unit": "days"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Received prior chemotherapeutic, investigational, or other therapies for the treatment of cancer ... within 28 days with biologic",
                                "criterion": "prior biologic therapy",
                                "requirement": {
                                    "requirement_type": "time since last treatment",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 28,
                                        "unit": "days"
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
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                "line": "* Progressive or symptomatic brain metastases",
                "criterions": [
                    {
                        "exact_snippets": "Progressive ... brain metastases",
                        "criterion": "brain metastases",
                        "requirement": {
                            "requirement_type": "progression",
                            "expected_value": "progressive"
                        }
                    },
                    {
                        "exact_snippets": "symptomatic brain metastases",
                        "criterion": "brain metastases",
                        "requirement": {
                            "requirement_type": "symptoms",
                            "expected_value": "symptomatic"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Progressive ... brain metastases",
                        "criterion": "brain metastases",
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                            "requirement_type": "progression",
                            "expected_value": "progressive"
                        }
                    },
                    {
                        "exact_snippets": "symptomatic brain metastases",
                        "criterion": "brain metastases",
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                            "requirement_type": "symptoms",
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                        }
                    }
                ]
            }
        },
        {
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                "line": "* Serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection",
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                        "criterion": "medical disorder",
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                        }
                    },
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                            "expected_value": false
                        }
                    },
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                    },
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                            "expected_value": true
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                        "criterion": "infection",
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                            "requirement_type": "control",
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                        }
                    }
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                        "and_criteria": [
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                                "and_criteria": [
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                                        "exact_snippets": "Serious, uncontrolled medical disorder",
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                                        }
                                    }
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        },
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            "identified_line": {
                "line": "* History of significant cardiac disease",
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                        "exact_snippets": "History of significant cardiac disease",
                        "criterion": "cardiac disease",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "History of significant cardiac disease",
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                        }
                    }
                ]
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            "logical_structure": {
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                        "exact_snippets": "History of significant cardiac disease",
                        "criterion": "cardiac disease",
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                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "History of significant cardiac disease",
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                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* History of myelodysplastic syndrome (MDS) or AML",
                "criterions": [
                    {
                        "exact_snippets": "History of myelodysplastic syndrome (MDS)",
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                        }
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                    {
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                        "criterion": "acute myeloid leukemia (AML)",
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                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
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                    {
                        "exact_snippets": "History of myelodysplastic syndrome (MDS)",
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                            "expected_value": true
                        }
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                        "criterion": "acute myeloid leukemia (AML)",
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                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* History of another cancer within 3 years before Day 1 of study treatment, with the exception of basal or squamous cell carcinoma of the skin that has been definitively treated. A history of other malignancies with a low risk of recurrence, including appropriately treated ductal carcinoma in situ (DCIS) of the breast and prostate cancer with a Gleason score less than or equal to 6, are also not excluded",
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                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "years"
                            }
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                            "expected_value": "definitively treated"
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                        "exact_snippets": "appropriately treated ductal carcinoma in situ (DCIS) of the breast",
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                        "exact_snippets": "prostate cancer with a Gleason score less than or equal to 6",
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                        "requirement": {
                            "requirement_type": "Gleason score",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "N/A"
                            }
                        }
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                ]
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                                    "exact_snippets": "History of another cancer within 3 years before Day 1 of study treatment",
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                                        "expected_value": {
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                                                }
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                                            {
                                                "exact_snippets": "prostate cancer with a Gleason score less than or equal to 6",
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                                                "requirement": {
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                                                    "expected_value": {
                                                        "operator": "<=",
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                                                        "unit": "N/A"
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        },
        {
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                "line": "* If female, is pregnant or breastfeeding",
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                        "exact_snippets": "If female, is pregnant",
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                            "requirement_type": "status",
                            "expected_value": false
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                    },
                    {
                        "exact_snippets": "If female, ... breastfeeding",
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                ]
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            "logical_structure": {
                "condition": {
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                            "exact_snippets": "If female, is pregnant",
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                            }
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                            "exact_snippets": "If female, ... breastfeeding",
                            "criterion": "breastfeeding",
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                            }
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                },
                "else_criteria": null
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}