{
    "info": {
        "nct_id": "NCT05304962",
        "official_title": "First-in-Human, Escalating Oral Dose Study of RGT-419B Given Alone and With Endocrine Therapy in Subjects With Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative Advanced/Metastatic Breast Cancer",
        "inclusion_criteria": "1. Male or female >/= 18 years old\n2. ECOG Performance Status 0 to 1\n3. Subjects must have histologically or cytologically confirmed diagnosis of ER+, HER2- ABC consistent with ASCO CAP guidelines that is locally advanced and unresectable (Stage III) or metastatic (Stage IV) BC.\n4. Measurable AND evaluable lesions at baseline per RECIST v1.1.\n5. Eligible subjects must meet all of the following criteria:\n\n   * Progression after receiving 1 line of prior cyclin-dependent kinase 4 and 6 inhibitor (CDK4/6i) therapy combined with HT in the MBC setting (up to 1 additional line of CDK4/6i is permitted in the post-surgical adjuvant setting);\n\n     * Subjects must have received therapy for ≥3 months in the MBC setting, or for ≥6 months in the adjuvant setting, prior to progression\n   * Progression after ≤3 lines of prior HT therapy (regardless of whether it is HT alone or in combination with other therapies)\n\n     * Prior HT combination agents, including SERD, SERM or AI, must have received formal approval by regulatory agency.\n   * ≤ 1 prior line of chemotherapy in the metastatic setting\n6. Adequate organ function\n7. Ability to understand and the willingness to sign a written informed consent document\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Presence of visceral metastases with severe organ dysfunction as evidence by signs and symptoms, laboratory studies, lymphangitic spread and/or rapid progression of disease\n2. Pregnant or planning to become pregnant\n3. Prior irradiation to >25% of the bone marrow and/or inadequate bone marrow function or evidence of clinically significant end-organ damage\n4. Major surgery, chemotherapy, targeted therapy, experimental agents, or radiation within 14-28 days prior to Cycle 1, Day 1\n5. Active, serious medical condition that is not well controlled with locally approved medications allowed by the protocol\n6. History of allergic reactions attributed to compounds of similar chemical or biologic composition to the drugs used in the study",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Male or female >/= 18 years old",
            "criterions": [
                {
                    "exact_snippets": "Male or female",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": ">/= 18 years old",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. ECOG Performance Status 0 to 1",
            "criterions": [
                {
                    "exact_snippets": "ECOG Performance Status 0 to 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": "3. Subjects must have histologically or cytologically confirmed diagnosis of ER+, HER2- ABC consistent with ASCO CAP guidelines that is locally advanced and unresectable (Stage III) or metastatic (Stage IV) BC.",
            "criterions": [
                {
                    "exact_snippets": "histologically or cytologically confirmed diagnosis",
                    "criterion": "diagnosis confirmation method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "ER+",
                    "criterion": "ER status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "HER2-",
                    "criterion": "HER2 status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "ABC consistent with ASCO CAP guidelines",
                    "criterion": "ABC consistency",
                    "requirements": [
                        {
                            "requirement_type": "guideline consistency",
                            "expected_value": "ASCO CAP"
                        }
                    ]
                },
                {
                    "exact_snippets": "locally advanced and unresectable (Stage III)",
                    "criterion": "cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "Stage III"
                        }
                    ]
                },
                {
                    "exact_snippets": "metastatic (Stage IV)",
                    "criterion": "cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "Stage IV"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Measurable AND evaluable lesions at baseline per RECIST v1.1.",
            "criterions": [
                {
                    "exact_snippets": "Measurable ... lesions at baseline per RECIST v1.1.",
                    "criterion": "lesions",
                    "requirements": [
                        {
                            "requirement_type": "measurability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "evaluable lesions at baseline per RECIST v1.1.",
                    "criterion": "lesions",
                    "requirements": [
                        {
                            "requirement_type": "evaluability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Progression after receiving 1 line of prior cyclin-dependent kinase 4 and 6 inhibitor (CDK4/6i) therapy combined with HT in the MBC setting (up to 1 additional line of CDK4/6i is permitted in the post-surgical adjuvant setting);",
            "criterions": [
                {
                    "exact_snippets": "Progression after receiving 1 line of prior cyclin-dependent kinase 4 and 6 inhibitor (CDK4/6i) therapy",
                    "criterion": "progression after CDK4/6i therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "1 line of prior cyclin-dependent kinase 4 and 6 inhibitor (CDK4/6i) therapy",
                    "criterion": "prior CDK4/6i therapy",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "=",
                                "value": 1,
                                "unit": "line"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "combined with HT in the MBC setting",
                    "criterion": "combination with HT in MBC setting",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "up to 1 additional line of CDK4/6i is permitted in the post-surgical adjuvant setting",
                    "criterion": "additional line of CDK4/6i in post-surgical adjuvant setting",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "line"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects must have received therapy for ≥3 months in the MBC setting, or for ≥6 months in the adjuvant setting, prior to progression",
            "criterions": [
                {
                    "exact_snippets": "received therapy for ≥3 months in the MBC setting",
                    "criterion": "therapy duration in MBC setting",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "received therapy for ... ≥6 months in the adjuvant setting",
                    "criterion": "therapy duration in adjuvant setting",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Progression after ≤3 lines of prior HT therapy (regardless of whether it is HT alone or in combination with other therapies)",
            "criterions": [
                {
                    "exact_snippets": "Progression after ≤3 lines of prior HT therapy",
                    "criterion": "prior HT therapy",
                    "requirements": [
                        {
                            "requirement_type": "progression",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "lines",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior HT combination agents, including SERD, SERM or AI, must have received formal approval by regulatory agency.",
            "criterions": [
                {
                    "exact_snippets": "Prior HT combination agents, including SERD, SERM or AI",
                    "criterion": "HT combination agents",
                    "requirements": [
                        {
                            "requirement_type": "prior use",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "must have received formal approval by regulatory agency",
                    "criterion": "regulatory approval",
                    "requirements": [
                        {
                            "requirement_type": "approval status",
                            "expected_value": "approved"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ≤ 1 prior line of chemotherapy in the metastatic setting",
            "criterions": [
                {
                    "exact_snippets": "≤ 1 prior line of chemotherapy in the metastatic setting",
                    "criterion": "prior lines of chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "lines"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Adequate organ function",
            "criterions": [
                {
                    "exact_snippets": "Adequate organ function",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Ability to understand and the willingness to sign a written informed consent document",
            "criterions": [
                {
                    "exact_snippets": "Ability to understand",
                    "criterion": "cognitive ability",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "willingness to sign a written informed consent document",
                    "criterion": "willingness to consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Presence of visceral metastases with severe organ dysfunction as evidence by signs and symptoms, laboratory studies, lymphangitic spread and/or rapid progression of disease",
            "criterions": [
                {
                    "exact_snippets": "Presence of visceral metastases",
                    "criterion": "visceral metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "severe organ dysfunction",
                    "criterion": "organ dysfunction",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                },
                {
                    "exact_snippets": "evidence by signs and symptoms",
                    "criterion": "signs and symptoms",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "evidence by ... laboratory studies",
                    "criterion": "laboratory studies",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "evidence by ... lymphangitic spread",
                    "criterion": "lymphangitic spread",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "evidence by ... rapid progression of disease",
                    "criterion": "rapid progression of disease",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Pregnant or planning to become pregnant",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "planning to become pregnant",
                    "criterion": "pregnancy intention",
                    "requirements": [
                        {
                            "requirement_type": "intention",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Prior irradiation to >25% of the bone marrow and/or inadequate bone marrow function or evidence of clinically significant end-organ damage",
            "criterions": [
                {
                    "exact_snippets": "Prior irradiation to >25% of the bone marrow",
                    "criterion": "bone marrow irradiation",
                    "requirements": [
                        {
                            "requirement_type": "extent",
                            "expected_value": {
                                "operator": ">",
                                "value": 25,
                                "unit": "% of the bone marrow"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "inadequate bone marrow function",
                    "criterion": "bone marrow function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "evidence of clinically significant end-organ damage",
                    "criterion": "end-organ damage",
                    "requirements": [
                        {
                            "requirement_type": "clinical significance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Major surgery, chemotherapy, targeted therapy, experimental agents, or radiation within 14-28 days prior to Cycle 1, Day 1",
            "criterions": [
                {
                    "exact_snippets": "Major surgery ... within 14-28 days prior to Cycle 1, Day 1",
                    "criterion": "major surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since procedure",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 14,
                                        "unit": "days"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 28,
                                        "unit": "days"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "chemotherapy ... within 14-28 days prior to Cycle 1, Day 1",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 14,
                                        "unit": "days"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 28,
                                        "unit": "days"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "targeted therapy ... within 14-28 days prior to Cycle 1, Day 1",
                    "criterion": "targeted therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 14,
                                        "unit": "days"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 28,
                                        "unit": "days"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "experimental agents ... within 14-28 days prior to Cycle 1, Day 1",
                    "criterion": "experimental agents",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 14,
                                        "unit": "days"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 28,
                                        "unit": "days"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "radiation within 14-28 days prior to Cycle 1, Day 1",
                    "criterion": "radiation",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 14,
                                        "unit": "days"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 28,
                                        "unit": "days"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Active, serious medical condition that is not well controlled with locally approved medications allowed by the protocol",
            "criterions": [
                {
                    "exact_snippets": "Active, serious medical condition",
                    "criterion": "medical condition",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "active"
                        },
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        }
                    ]
                },
                {
                    "exact_snippets": "not well controlled with locally approved medications",
                    "criterion": "control of medical condition",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "not well controlled"
                        },
                        {
                            "requirement_type": "medication approval",
                            "expected_value": "locally approved"
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. History of allergic reactions attributed to compounds of similar chemical or biologic composition to the drugs used in the study",
            "criterions": [
                {
                    "exact_snippets": "History of allergic reactions attributed to compounds of similar chemical or biologic composition to the drugs used in the study",
                    "criterion": "allergic reactions to similar compounds",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "5. Eligible subjects must meet all of the following criteria:",
            "criterions": []
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}