{
    "info": {
        "nct_id": "NCT02829372",
        "official_title": "A Phase 1, First-in-man, Multicenter, Open-label, Dose-escalation Study of Single-agent GBR 1302 in Subjects With HER2 Positive Cancers",
        "inclusion_criteria": "1. Progressive HER2 positive solid tumours (immunohistochemistry [IHC] positive or equivocal) with no available standard or curative treatment.\n2. Eastern Cooperative Oncology Group (ECOG) performance score of 0-2.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Active infectious disease considered by the Investigator to be incompatible with the protocol.\n2. Patients not recovered from any therapy-related toxicities from previous therapies to at least CTCAE ≤ Grade 1 except in case of liver metastases or Gilbert's Syndrome or alopecia.\n3. Brain metastases that are symptomatic or untreated or that require current therapy.\n4. Previous treatment with immunotherapy within 8 weeks of starting study medication, chemotherapy, radiotherapy, molecular-targeted therapy, or biological therapies (including HER2 directed therapies) within 4 weeks of starting study medication, or hormone therapy within 2 weeks of starting study medication.\n5. Use of any investigational drug within the past 4 weeks before start of study medication or concomitantly with this study except for investigational immune-stimulatory therapy (e.g. checkpoint-regulator targeted treatment). The minimum washout period should be 8 weeks before starting the study medication.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Progressive HER2 positive solid tumours (immunohistochemistry [IHC] positive or equivocal) with no available standard or curative treatment.",
            "criterions": [
                {
                    "exact_snippets": "Progressive HER2 positive solid tumours",
                    "criterion": "HER2 status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "Progressive HER2 positive solid tumours",
                    "criterion": "tumour progression",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "progressive"
                        }
                    ]
                },
                {
                    "exact_snippets": "immunohistochemistry [IHC] positive or equivocal",
                    "criterion": "IHC status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "positive",
                                "equivocal"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "no available standard or curative treatment",
                    "criterion": "treatment availability",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Eastern Cooperative Oncology Group (ECOG) performance score of 0-2.",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance score of 0-2.",
                    "criterion": "ECOG performance score",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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. Active infectious disease considered by the Investigator to be incompatible with the protocol.",
            "criterions": [
                {
                    "exact_snippets": "Active infectious disease considered by the Investigator to be incompatible with the protocol.",
                    "criterion": "active infectious disease",
                    "requirements": [
                        {
                            "requirement_type": "compatibility with protocol",
                            "expected_value": "incompatible"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Patients not recovered from any therapy-related toxicities from previous therapies to at least CTCAE ≤ Grade 1 except in case of liver metastases or Gilbert's Syndrome or alopecia.",
            "criterions": [
                {
                    "exact_snippets": "Patients not recovered from any therapy-related toxicities ... to at least CTCAE ≤ Grade 1",
                    "criterion": "recovery from therapy-related toxicities",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "CTCAE Grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "liver metastases",
                    "criterion": "liver metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Gilbert's Syndrome",
                    "criterion": "Gilbert's Syndrome",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "alopecia",
                    "criterion": "alopecia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Brain metastases that are symptomatic or untreated or that require current therapy.",
            "criterions": [
                {
                    "exact_snippets": "Brain metastases that are symptomatic",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "symptomatic",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Brain metastases that are ... untreated",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "untreated"
                        }
                    ]
                },
                {
                    "exact_snippets": "Brain metastases that ... require current therapy",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "current therapy requirement",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Previous treatment with immunotherapy within 8 weeks of starting study medication, chemotherapy, radiotherapy, molecular-targeted therapy, or biological therapies (including HER2 directed therapies) within 4 weeks of starting study medication, or hormone therapy within 2 weeks of starting study medication.",
            "criterions": [
                {
                    "exact_snippets": "Previous treatment with immunotherapy within 8 weeks of starting study medication",
                    "criterion": "previous immunotherapy treatment",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 8,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "chemotherapy, radiotherapy, molecular-targeted therapy, or biological therapies (including HER2 directed therapies) within 4 weeks of starting study medication",
                    "criterion": "previous chemotherapy, radiotherapy, molecular-targeted therapy, or biological therapies",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "hormone therapy within 2 weeks of starting study medication",
                    "criterion": "previous hormone therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Use of any investigational drug within the past 4 weeks before start of study medication or concomitantly with this study except for investigational immune-stimulatory therapy (e.g. checkpoint-regulator targeted treatment). The minimum washout period should be 8 weeks before starting the study medication.",
            "criterions": [
                {
                    "exact_snippets": "Use of any investigational drug within the past 4 weeks before start of study medication",
                    "criterion": "use of investigational drug",
                    "requirements": [
                        {
                            "requirement_type": "time since last use",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "concomitantly with this study",
                    "criterion": "use of investigational drug",
                    "requirements": [
                        {
                            "requirement_type": "concomitant use",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "except for investigational immune-stimulatory therapy (e.g. checkpoint-regulator targeted treatment)",
                    "criterion": "use of investigational immune-stimulatory therapy",
                    "requirements": [
                        {
                            "requirement_type": "exemption",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "The minimum washout period should be 8 weeks before starting the study medication",
                    "criterion": "washout period",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 8,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}