{
    "info": {
        "nct_id": "NCT04965220",
        "official_title": "A Phase I Clinical Trial Evaluating the Safety, Tolerability, Pharmacokinetics, and Initial Efficacy of HLX208 (BRAF V600E Inhibitor) in Combination With Trametinib in Patients With Advanced Solid Tumors",
        "inclusion_criteria": "* 18Y≤Age≤75Y\n* Good Organ Function\n* Expected survival time ≥ 3 months\n* Metastatic/recurrent advanced BRAF+ solid tumors that have been diagnosed histologically and have failed standard treatment\n* Previous failure to standard treatment, intolerance to standard treatment, absence of standard treatment, or insuitability for standard treatment at this stage.\n* ECOG score 0-1;\n* Expected survival time of more than 3 months;\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
        "exclusion_criteria": "* Previous treatment with BRAF inhibitors or MEK inhibitors\n* Symptomatic brain or meningeal metastases (unless the patient has been on > treatment for 6 months, has no evidence of progress on imaging within 4 weeks prior to initial administration, and tumor-related clinical symptoms are stable).\n* Current or former patients with interstitial lung disease;\n* Active clinical severe infection;\n* A history of other malignancies within two years, except for cured carcinoma in situ of the cervix or basal cell carcinoma of the skin.\n* Other anti-tumor treatments, such as chemotherapy, targeted therapy, or radiation therapy (except palliative radiation therapy), may be given during the study period.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* 18Y≤Age≤75Y",
            "criterions": [
                {
                    "exact_snippets": "18Y≤Age≤75Y",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "Y"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 75,
                                        "unit": "Y"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Good Organ Function",
            "criterions": [
                {
                    "exact_snippets": "Good Organ Function",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "quality",
                            "expected_value": "good"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Expected survival time ≥ 3 months",
            "criterions": [
                {
                    "exact_snippets": "Expected survival time ≥ 3 months",
                    "criterion": "expected survival time",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Metastatic/recurrent advanced BRAF+ solid tumors that have been diagnosed histologically and have failed standard treatment",
            "criterions": [
                {
                    "exact_snippets": "Metastatic/recurrent advanced BRAF+ solid tumors",
                    "criterion": "BRAF+ solid tumors",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "metastatic",
                                "recurrent",
                                "advanced"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "diagnosed histologically",
                    "criterion": "diagnosis method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": "histologically"
                        }
                    ]
                },
                {
                    "exact_snippets": "failed standard treatment",
                    "criterion": "treatment response",
                    "requirements": [
                        {
                            "requirement_type": "response",
                            "expected_value": "failed"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Previous failure to standard treatment, intolerance to standard treatment, absence of standard treatment, or insuitability for standard treatment at this stage.",
            "criterions": [
                {
                    "exact_snippets": "Previous failure to standard treatment",
                    "criterion": "standard treatment",
                    "requirements": [
                        {
                            "requirement_type": "response",
                            "expected_value": "failure"
                        }
                    ]
                },
                {
                    "exact_snippets": "intolerance to standard treatment",
                    "criterion": "standard treatment",
                    "requirements": [
                        {
                            "requirement_type": "tolerance",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "absence of standard treatment",
                    "criterion": "standard treatment",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "insuitability for standard treatment at this stage",
                    "criterion": "standard treatment",
                    "requirements": [
                        {
                            "requirement_type": "suitability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ECOG score 0-1;",
            "criterions": [
                {
                    "exact_snippets": "ECOG score 0-1",
                    "criterion": "ECOG score",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Expected survival time of more than 3 months;",
            "criterions": [
                {
                    "exact_snippets": "Expected survival time of more than 3 months",
                    "criterion": "survival time",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 75 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 75 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 75,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Previous treatment with BRAF inhibitors or MEK inhibitors",
            "criterions": [
                {
                    "exact_snippets": "Previous treatment with BRAF inhibitors",
                    "criterion": "BRAF inhibitor treatment",
                    "requirements": [
                        {
                            "requirement_type": "previous treatment",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Previous treatment with ... MEK inhibitors",
                    "criterion": "MEK inhibitor treatment",
                    "requirements": [
                        {
                            "requirement_type": "previous treatment",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Symptomatic brain or meningeal metastases (unless the patient has been on > treatment for 6 months, has no evidence of progress on imaging within 4 weeks prior to initial administration, and tumor-related clinical symptoms are stable).",
            "criterions": [
                {
                    "exact_snippets": "Symptomatic brain or meningeal metastases",
                    "criterion": "brain or meningeal metastases",
                    "requirements": [
                        {
                            "requirement_type": "symptomatic",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "unless the patient has been on > treatment for 6 months",
                    "criterion": "treatment duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "no evidence of progress on imaging within 4 weeks prior to initial administration",
                    "criterion": "progress on imaging",
                    "requirements": [
                        {
                            "requirement_type": "evidence of progress",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "tumor-related clinical symptoms are stable",
                    "criterion": "tumor-related clinical symptoms",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": "stable"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Current or former patients with interstitial lung disease;",
            "criterions": [
                {
                    "exact_snippets": "Current or former patients with interstitial lung disease",
                    "criterion": "interstitial lung disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active clinical severe infection;",
            "criterions": [
                {
                    "exact_snippets": "Active clinical severe infection",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* A history of other malignancies within two years, except for cured carcinoma in situ of the cervix or basal cell carcinoma of the skin.",
            "criterions": [
                {
                    "exact_snippets": "A history of other malignancies within two years",
                    "criterion": "history of other malignancies",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "except for cured carcinoma in situ of the cervix",
                    "criterion": "cured carcinoma in situ of the cervix",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "except for ... basal cell carcinoma of the skin",
                    "criterion": "basal cell carcinoma of the skin",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Other anti-tumor treatments, such as chemotherapy, targeted therapy, or radiation therapy (except palliative radiation therapy), may be given during the study period.",
            "criterions": [
                {
                    "exact_snippets": "Other anti-tumor treatments, such as chemotherapy, targeted therapy, or radiation therapy (except palliative radiation therapy)",
                    "criterion": "anti-tumor treatments",
                    "requirements": [
                        {
                            "requirement_type": "types",
                            "expected_value": [
                                "chemotherapy",
                                "targeted therapy",
                                "radiation therapy"
                            ]
                        },
                        {
                            "requirement_type": "exclusion",
                            "expected_value": "palliative radiation therapy"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}