{
    "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": [
        {
            "line": "* Advanced solid tumor",
            "criterions": [
                {
                    "exact_snippets": "Advanced solid tumor",
                    "criterion": "solid tumor",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "advanced"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Measurable disease, per RECIST v1.1",
            "criterions": [
                {
                    "exact_snippets": "Measurable disease, per RECIST v1.1",
                    "criterion": "measurable disease",
                    "requirements": [
                        {
                            "requirement_type": "measurement standard",
                            "expected_value": "RECIST v1.1"
                        }
                    ]
                }
            ]
        },
        {
            "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",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate organ function",
            "criterions": [
                {
                    "exact_snippets": "Adequate organ function",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "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": "* 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",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "NCI CTCAE grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "treatment-related alopecia",
                    "criterion": "treatment-related alopecia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "laboratory abnormalities otherwise meeting eligibility requirements",
                    "criterion": "laboratory abnormalities",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": "otherwise meeting eligibility requirements"
                        }
                    ]
                }
            ]
        },
        {
            "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",
                    "requirements": [
                        {
                            "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",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Progressive or symptomatic brain metastases",
            "criterions": [
                {
                    "exact_snippets": "Progressive ... brain metastases",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "progression",
                            "expected_value": "progressive"
                        }
                    ]
                },
                {
                    "exact_snippets": "symptomatic brain metastases",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "symptoms",
                            "expected_value": "symptomatic"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection",
            "criterions": [
                {
                    "exact_snippets": "Serious, uncontrolled medical disorder",
                    "criterion": "medical disorder",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        },
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "nonmalignant systemic disease",
                    "criterion": "systemic disease",
                    "requirements": [
                        {
                            "requirement_type": "malignancy",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "active, uncontrolled infection",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of significant cardiac disease",
            "criterions": [
                {
                    "exact_snippets": "History of significant cardiac disease",
                    "criterion": "cardiac disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of myelodysplastic syndrome (MDS) or AML",
            "criterions": [
                {
                    "exact_snippets": "History of myelodysplastic syndrome (MDS)",
                    "criterion": "myelodysplastic syndrome (MDS)",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of ... AML",
                    "criterion": "acute myeloid leukemia (AML)",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "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",
            "criterions": [
                {
                    "exact_snippets": "History of another cancer within 3 years before Day 1 of study treatment",
                    "criterion": "history of another cancer",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "basal or squamous cell carcinoma of the skin that has been definitively treated",
                    "criterion": "basal or squamous cell carcinoma of the skin",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "definitively treated"
                        }
                    ]
                },
                {
                    "exact_snippets": "history of other malignancies with a low risk of recurrence",
                    "criterion": "history of other malignancies",
                    "requirements": [
                        {
                            "requirement_type": "risk of recurrence",
                            "expected_value": "low"
                        }
                    ]
                },
                {
                    "exact_snippets": "appropriately treated ductal carcinoma in situ (DCIS) of the breast",
                    "criterion": "ductal carcinoma in situ (DCIS) of the breast",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "appropriately treated"
                        }
                    ]
                },
                {
                    "exact_snippets": "prostate cancer with a Gleason score less than or equal to 6",
                    "criterion": "prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "Gleason score",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* If female, is pregnant or breastfeeding",
            "criterions": [
                {
                    "exact_snippets": "If female, is pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "If female, ... breastfeeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}