{
    "info": {
        "nct_id": "NCT05041972",
        "official_title": "A Global Phase 2 Study to Evaluate the Efficacy and Safety of ARX788 for Selected HER2-mutated or HER2-amplified/Overexpressed Solid Tumors",
        "inclusion_criteria": "* Age ≥ 18 years and older\n* Life expectancy > 3 months\n* Eastern Cooperative Oncology Performance Status ≤ 1\n* HER2 status must be determined from a local Clinical Laboratory Improvement Amendments (CLIA) or equivalent-certified laboratory.\n* Cohort 1, Cohort 2, and Explanatory Cohort A: HER2 mutated subjects with pre-specified HER2 activating mutation. Subjects with HER2 mutations in NSCLC (Cohort 1), breast cancer (Cohort 2), and other solid tumors (Cohort A) who have not received prior HER2 antibody drug conjugate (ADC) treatment are eligible.\n* Cohort 3: Subjects with HER2 amplifications in biliary tract cancers (BTC) who have not received prior HER2 ADC treatment are eligible.\n* Cohort 4: Subjects with HER2 amplifications in colorectal cancer (CRC), ovarian, endometrial, NSCLC and other solid tumors who have not received prior HER2 ADC treatment are eligible.\n* Cohort 5 HER2 mutation or HER2 amplification: subjects with HER2 mutated or amplified tumors and have been previously treated with HER2 ADC are eligible.\n* Subjects who are resistant or refractory to previous standard care of treatment.\n* Subjects with stable brain metastases.\n* Adequate organ functions.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "Any subject who meets any of the following criteria is excluded from the study:\n\n* For Cohort 4: breast and gastric/GEJ cancer are excluded.\n* Prior history of interstitial lung disease, pneumonitis, or other clinically significant lung disease within 12 months.\n* History of ocular events, any current ongoing active ocular infections, or any chronic corneal disease unless approved by Medical Monitor.\n* Exposure to any other investigational or commercial anticancer agents or therapies administered with the intention to treat malignancy within 14 days before the first dose of ARX788.\n* Clinically significant surgical intervention (excluding diagnostic biopsy) within 21 days of the first dose of ARX788.\n* Radiotherapy administered less than 21 days prior to the first dose of ARX788, or localized palliative radiotherapy administered less than 7 days prior to the first dose of ARX788, or radiotherapy-induced toxicity of Grade 2 or greater based on NCI-CTCAE v 5.0.\n\nThere are additional inclusion and exclusion criteria. The study center will determine if criteria for participation are met.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Age ≥ 18 years and older",
            "criterions": [
                {
                    "exact_snippets": "Age ≥ 18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Life expectancy > 3 months",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy > 3 months",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Eastern Cooperative Oncology Performance Status ≤ 1",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Performance Status ≤ 1",
                    "criterion": "Eastern Cooperative Oncology Performance Status",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* HER2 status must be determined from a local Clinical Laboratory Improvement Amendments (CLIA) or equivalent-certified laboratory.",
            "criterions": [
                {
                    "exact_snippets": "HER2 status must be determined",
                    "criterion": "HER2 status",
                    "requirements": [
                        {
                            "requirement_type": "determination",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "local Clinical Laboratory Improvement Amendments (CLIA) or equivalent-certified laboratory",
                    "criterion": "laboratory certification",
                    "requirements": [
                        {
                            "requirement_type": "certification",
                            "expected_value": [
                                "CLIA",
                                "equivalent"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Cohort 1, Cohort 2, and Explanatory Cohort A: HER2 mutated subjects with pre-specified HER2 activating mutation. Subjects with HER2 mutations in NSCLC (Cohort 1), breast cancer (Cohort 2), and other solid tumors (Cohort A) who have not received prior HER2 antibody drug conjugate (ADC) treatment are eligible.",
            "criterions": [
                {
                    "exact_snippets": "HER2 mutated subjects",
                    "criterion": "HER2 mutation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "pre-specified HER2 activating mutation",
                    "criterion": "HER2 activating mutation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "HER2 mutations in NSCLC (Cohort 1)",
                    "criterion": "NSCLC",
                    "requirements": [
                        {
                            "requirement_type": "HER2 mutation presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "HER2 mutations in ... breast cancer (Cohort 2)",
                    "criterion": "breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "HER2 mutation presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "HER2 mutations in ... other solid tumors (Cohort A)",
                    "criterion": "other solid tumors",
                    "requirements": [
                        {
                            "requirement_type": "HER2 mutation presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "who have not received prior HER2 antibody drug conjugate (ADC) treatment",
                    "criterion": "prior HER2 ADC treatment",
                    "requirements": [
                        {
                            "requirement_type": "absence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Cohort 3: Subjects with HER2 amplifications in biliary tract cancers (BTC) who have not received prior HER2 ADC treatment are eligible.",
            "criterions": [
                {
                    "exact_snippets": "HER2 amplifications",
                    "criterion": "HER2 amplification",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "biliary tract cancers (BTC)",
                    "criterion": "biliary tract cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "who have not received prior HER2 ADC treatment",
                    "criterion": "prior HER2 ADC treatment",
                    "requirements": [
                        {
                            "requirement_type": "absence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Cohort 4: Subjects with HER2 amplifications in colorectal cancer (CRC), ovarian, endometrial, NSCLC and other solid tumors who have not received prior HER2 ADC treatment are eligible.",
            "criterions": [
                {
                    "exact_snippets": "HER2 amplifications",
                    "criterion": "HER2 amplification",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "colorectal cancer (CRC), ovarian, endometrial, NSCLC and other solid tumors",
                    "criterion": "cancer type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "colorectal cancer",
                                "ovarian cancer",
                                "endometrial cancer",
                                "NSCLC",
                                "other solid tumors"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "who have not received prior HER2 ADC treatment",
                    "criterion": "prior HER2 ADC treatment",
                    "requirements": [
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Cohort 5 HER2 mutation or HER2 amplification: subjects with HER2 mutated or amplified tumors and have been previously treated with HER2 ADC are eligible.",
            "criterions": [
                {
                    "exact_snippets": "HER2 mutation",
                    "criterion": "HER2 mutation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "HER2 amplification",
                    "criterion": "HER2 amplification",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "previously treated with HER2 ADC",
                    "criterion": "treatment with HER2 ADC",
                    "requirements": [
                        {
                            "requirement_type": "previous treatment",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects who are resistant or refractory to previous standard care of treatment.",
            "criterions": [
                {
                    "exact_snippets": "Subjects who are resistant ... to previous standard care of treatment.",
                    "criterion": "resistance to previous standard care of treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Subjects who are ... refractory to previous standard care of treatment.",
                    "criterion": "refractoriness to previous standard care of treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects with stable brain metastases.",
            "criterions": [
                {
                    "exact_snippets": "stable brain metastases",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": "stable"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate organ functions.",
            "criterions": [
                {
                    "exact_snippets": "Adequate organ functions.",
                    "criterion": "organ functions",
                    "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": "* For Cohort 4: breast and gastric/GEJ cancer are excluded.",
            "criterions": [
                {
                    "exact_snippets": "breast ... are excluded",
                    "criterion": "breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "gastric/GEJ cancer are excluded",
                    "criterion": "gastric/GEJ cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior history of interstitial lung disease, pneumonitis, or other clinically significant lung disease within 12 months.",
            "criterions": [
                {
                    "exact_snippets": "Prior history of interstitial lung disease",
                    "criterion": "interstitial lung disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior history of ... pneumonitis",
                    "criterion": "pneumonitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior history of ... other clinically significant lung disease",
                    "criterion": "clinically significant lung disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of ocular events, any current ongoing active ocular infections, or any chronic corneal disease unless approved by Medical Monitor.",
            "criterions": [
                {
                    "exact_snippets": "History of ocular events",
                    "criterion": "ocular events",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "any current ongoing active ocular infections",
                    "criterion": "ocular infections",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "any chronic corneal disease",
                    "criterion": "chronic corneal disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Exposure to any other investigational or commercial anticancer agents or therapies administered with the intention to treat malignancy within 14 days before the first dose of ARX788.",
            "criterions": [
                {
                    "exact_snippets": "Exposure to any other investigational or commercial anticancer agents or therapies administered with the intention to treat malignancy within 14 days before the first dose of ARX788.",
                    "criterion": "exposure to anticancer agents or therapies",
                    "requirements": [
                        {
                            "requirement_type": "time since last exposure",
                            "expected_value": {
                                "operator": "<=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Clinically significant surgical intervention (excluding diagnostic biopsy) within 21 days of the first dose of ARX788.",
            "criterions": [
                {
                    "exact_snippets": "Clinically significant surgical intervention (excluding diagnostic biopsy) within 21 days of the first dose of ARX788.",
                    "criterion": "surgical intervention",
                    "requirements": [
                        {
                            "requirement_type": "significance",
                            "expected_value": "clinically significant"
                        },
                        {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<=",
                                "value": 21,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Radiotherapy administered less than 21 days prior to the first dose of ARX788, or localized palliative radiotherapy administered less than 7 days prior to the first dose of ARX788, or radiotherapy-induced toxicity of Grade 2 or greater based on NCI-CTCAE v 5.0.",
            "criterions": [
                {
                    "exact_snippets": "Radiotherapy administered less than 21 days prior to the first dose of ARX788",
                    "criterion": "radiotherapy administration",
                    "requirements": [
                        {
                            "requirement_type": "time since administration",
                            "expected_value": {
                                "operator": "<",
                                "value": 21,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "localized palliative radiotherapy administered less than 7 days prior to the first dose of ARX788",
                    "criterion": "localized palliative radiotherapy administration",
                    "requirements": [
                        {
                            "requirement_type": "time since administration",
                            "expected_value": {
                                "operator": "<",
                                "value": 7,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "radiotherapy-induced toxicity of Grade 2 or greater based on NCI-CTCAE v 5.0",
                    "criterion": "radiotherapy-induced toxicity",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "Grade"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "Any subject who meets any of the following criteria is excluded from the study:",
            "criterions": []
        },
        {
            "line": "There are additional inclusion and exclusion criteria. The study center will determine if criteria for participation are met.",
            "criterions": []
        }
    ],
    "failed_miscellaneous": []
}