{
    "info": {
        "nct_id": "NCT04840394",
        "official_title": "Phase 1 Open-Label Dose Escalation Study of BDB001 as a Single Agent and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors",
        "inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Has disease that is suitable for local therapy administered with curative intent.\n2. Prior exposure to TLR7 agonists, TLR8 agonists, TLR 7/8 dual agonists, and TLR9 agonists.\n\nOther protocol defined inclusion/exclusion criteria could apply",
        "miscellaneous_criteria": "Inclusion Criteria\n\n1. Histologically or cytologically confirmed advanced or metastatic solid tumors that have disease progression after treatment with all available therapies for metastatic disease that are known to confer clinical benefit, or are intolerant to treatment, or refuse standard treatment. Note: there is no limit to the number of prior treatment regimens\n2. Evidence of progressive disease (PD) within 3 months of signing the informed consent form.\n3. Have measurable disease"
    },
    "inclusion_lines": [
        {
            "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. Has disease that is suitable for local therapy administered with curative intent.",
            "criterions": [
                {
                    "exact_snippets": "disease that is suitable for local therapy",
                    "criterion": "disease suitability for local therapy",
                    "requirements": [
                        {
                            "requirement_type": "suitability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "local therapy administered with curative intent",
                    "criterion": "local therapy intent",
                    "requirements": [
                        {
                            "requirement_type": "intent",
                            "expected_value": "curative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Prior exposure to TLR7 agonists, TLR8 agonists, TLR 7/8 dual agonists, and TLR9 agonists.",
            "criterions": [
                {
                    "exact_snippets": "Prior exposure to TLR7 agonists",
                    "criterion": "TLR7 agonists",
                    "requirements": [
                        {
                            "requirement_type": "prior exposure",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior exposure to ... TLR8 agonists",
                    "criterion": "TLR8 agonists",
                    "requirements": [
                        {
                            "requirement_type": "prior exposure",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior exposure to ... TLR 7/8 dual agonists",
                    "criterion": "TLR 7/8 dual agonists",
                    "requirements": [
                        {
                            "requirement_type": "prior exposure",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior exposure to ... TLR9 agonists",
                    "criterion": "TLR9 agonists",
                    "requirements": [
                        {
                            "requirement_type": "prior exposure",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Other protocol defined inclusion/exclusion criteria could apply",
            "criterions": [
                {
                    "exact_snippets": "Other protocol defined inclusion/exclusion criteria",
                    "criterion": "protocol defined criteria",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [
        {
            "line": "1. Histologically or cytologically confirmed advanced or metastatic solid tumors that have disease progression after treatment with all available therapies for metastatic disease that are known to confer clinical benefit, or are intolerant to treatment, or refuse standard treatment. Note: there is no limit to the number of prior treatment regimens",
            "criterions": [
                {
                    "exact_snippets": "Histologically or cytologically confirmed advanced or metastatic solid tumors",
                    "criterion": "advanced or metastatic solid tumors",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "disease progression after treatment with all available therapies for metastatic disease that are known to confer clinical benefit",
                    "criterion": "disease progression after treatment",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "progression"
                        }
                    ]
                },
                {
                    "exact_snippets": "intolerant to treatment",
                    "criterion": "treatment intolerance",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "refuse standard treatment",
                    "criterion": "refusal of standard treatment",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Evidence of progressive disease (PD) within 3 months of signing the informed consent form.",
            "criterions": [
                {
                    "exact_snippets": "Evidence of progressive disease (PD)",
                    "criterion": "progressive disease",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "within 3 months of signing the informed consent form",
                    "criterion": "time since signing informed consent",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Have measurable disease",
            "criterions": [
                {
                    "exact_snippets": "measurable disease",
                    "criterion": "disease",
                    "requirements": [
                        {
                            "requirement_type": "measurability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "Inclusion Criteria",
            "criterions": []
        }
    ]
}