{
    "info": {
        "nct_id": "NCT06047431",
        "official_title": "A Phase Ⅰ Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Efficacy of QL1706H in Advanced Solid Tumors",
        "inclusion_criteria": "* Subjects participate voluntarily and sign informed consent.\n* Patients with Pathologically confirmed metastatic or recurrent malignant solid tumors, failure or intolerance of at least first-line treatment and unsuitable for radical treatment such as surgery\n* Subject has at least one measurable lesion according to RECIST (V1.1) evaluation criteria.\n* Eastern Cooperative Oncology Group (ECOG) score was 0 or 1.\n* The extension of life is more than 3 months\n* Vital organs' function is adequate for enrolling\n* Subjects agree to use effective contraceptive measures.Women who have not been pregnant or breastfeeding.\n* Before the first use of the investigational drug, all the reversible toxicity of the previous antitumor therapy returned to ≤1 (according to CTCAE V5.0),Excluding any grade of hair loss and pigmentation, grade 2 or less peripheral sensory neuropathy, and other abnormalities that the investigator and/or sponsor assessed to outweigh the risk of toxicity.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Active autoimmune diseases that exist within 2 years prior to the first use of the investigational drug and require systemic treatment.\n* There are known past grade 3 or 4 immune-related adverse events associated with antitumor immunotherapy.\n* Symptomatic central nervous system (CNS) metastasis, pia metastasis or spinal cord compression due to metastasis prior to signing informed consent.\n* Subjects with any of the following cardiovascular diseases that seriously endanger the safety of the subjects or affect the completion of the study\n* Subjects with diseases that are planned to be treated with systemic corticosteroids or other immunosuppressive drugs during the study period\n* Prior treatment with cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) inhibitor combined with programmed cell death protein-1 (PD-1) inhibitor, or CTLA-4 inhibitor combined with PD-L1 inhibitor.\n* Had received chemotherapy, targeted therapy, biotherapy, endocrine therapy, immunotherapy and other anti-tumor treatments within 4 weeks before the first use of experimental drugs\n* Subjects with positive antibodies to HIV;Treponema pallidum antibody positive;HBsAg positive patients with VIRAL DEoxy ribonucleic acid (HBV DNA) >2000 IU/ mL or 10^4 copy number/mL should receive antiviral therapy according to local treatment guidelines and be willing to receive antiviral therapy throughout the study period.Hepatitis C virus antibody positive and viral ribonucleic acid (HCV RNA) positive",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Subjects participate voluntarily and sign informed consent.",
            "criterions": [
                {
                    "exact_snippets": "Subjects participate voluntarily",
                    "criterion": "voluntary participation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "sign informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with Pathologically confirmed metastatic or recurrent malignant solid tumors, failure or intolerance of at least first-line treatment and unsuitable for radical treatment such as surgery",
            "criterions": [
                {
                    "exact_snippets": "Pathologically confirmed metastatic or recurrent malignant solid tumors",
                    "criterion": "metastatic or recurrent malignant solid tumors",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "pathologically confirmed"
                        }
                    ]
                },
                {
                    "exact_snippets": "failure or intolerance of at least first-line treatment",
                    "criterion": "first-line treatment",
                    "requirements": [
                        {
                            "requirement_type": "response",
                            "expected_value": [
                                "failure",
                                "intolerance"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "unsuitable for radical treatment such as surgery",
                    "criterion": "radical treatment",
                    "requirements": [
                        {
                            "requirement_type": "suitability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subject has at least one measurable lesion according to RECIST (V1.1) evaluation criteria.",
            "criterions": [
                {
                    "exact_snippets": "at least one measurable lesion according to RECIST (V1.1) evaluation criteria",
                    "criterion": "measurable lesion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "lesion"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Eastern Cooperative Oncology Group (ECOG) score was 0 or 1.",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) score was 0 or 1.",
                    "criterion": "ECOG score",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The extension of life is more than 3 months",
            "criterions": [
                {
                    "exact_snippets": "The extension of life is more than 3 months",
                    "criterion": "extension of life",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Vital organs' function is adequate for enrolling",
            "criterions": [
                {
                    "exact_snippets": "Vital organs' function is adequate",
                    "criterion": "vital organs' function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects agree to use effective contraceptive measures.Women who have not been pregnant or breastfeeding.",
            "criterions": [
                {
                    "exact_snippets": "Subjects agree to use effective contraceptive measures",
                    "criterion": "contraceptive use",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Women who have not been pregnant",
                    "criterion": "pregnancy history",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": "not been pregnant"
                        }
                    ]
                },
                {
                    "exact_snippets": "Women who have not been ... breastfeeding",
                    "criterion": "breastfeeding history",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": "not been breastfeeding"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Before the first use of the investigational drug, all the reversible toxicity of the previous antitumor therapy returned to ≤1 (according to CTCAE V5.0),Excluding any grade of hair loss and pigmentation, grade 2 or less peripheral sensory neuropathy, and other abnormalities that the investigator and/or sponsor assessed to outweigh the risk of toxicity.",
            "criterions": [
                {
                    "exact_snippets": "all the reversible toxicity of the previous antitumor therapy returned to ≤1 (according to CTCAE V5.0)",
                    "criterion": "reversible toxicity of previous antitumor therapy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "CTCAE V5.0"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Excluding any grade of hair loss",
                    "criterion": "hair loss",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "any grade"
                        }
                    ]
                },
                {
                    "exact_snippets": "Excluding ... grade 2 or less peripheral sensory neuropathy",
                    "criterion": "peripheral sensory neuropathy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Excluding ... other abnormalities that the investigator and/or sponsor assessed to outweigh the risk of toxicity",
                    "criterion": "other abnormalities",
                    "requirements": [
                        {
                            "requirement_type": "assessment",
                            "expected_value": "outweigh the risk of toxicity"
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Active autoimmune diseases that exist within 2 years prior to the first use of the investigational drug and require systemic treatment.",
            "criterions": [
                {
                    "exact_snippets": "Active autoimmune diseases",
                    "criterion": "autoimmune diseases",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "exist within 2 years prior to the first use of the investigational drug",
                    "criterion": "autoimmune diseases",
                    "requirements": [
                        {
                            "requirement_type": "existence timeframe",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "require systemic treatment",
                    "criterion": "autoimmune diseases",
                    "requirements": [
                        {
                            "requirement_type": "treatment requirement",
                            "expected_value": "systemic treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* There are known past grade 3 or 4 immune-related adverse events associated with antitumor immunotherapy.",
            "criterions": [
                {
                    "exact_snippets": "known past grade 3 or 4 immune-related adverse events",
                    "criterion": "immune-related adverse events",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": [
                                "grade 3",
                                "grade 4"
                            ]
                        },
                        {
                            "requirement_type": "temporal",
                            "expected_value": "past"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Symptomatic central nervous system (CNS) metastasis, pia metastasis or spinal cord compression due to metastasis prior to signing informed consent.",
            "criterions": [
                {
                    "exact_snippets": "Symptomatic central nervous system (CNS) metastasis",
                    "criterion": "central nervous system (CNS) metastasis",
                    "requirements": [
                        {
                            "requirement_type": "symptomatic",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "pia metastasis",
                    "criterion": "pia metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "spinal cord compression due to metastasis",
                    "criterion": "spinal cord compression",
                    "requirements": [
                        {
                            "requirement_type": "cause",
                            "expected_value": "metastasis"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects with any of the following cardiovascular diseases that seriously endanger the safety of the subjects or affect the completion of the study",
            "criterions": [
                {
                    "exact_snippets": "any of the following cardiovascular diseases",
                    "criterion": "cardiovascular diseases",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "seriously endanger the safety of the subjects or affect the completion of the study"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects with diseases that are planned to be treated with systemic corticosteroids or other immunosuppressive drugs during the study period",
            "criterions": [
                {
                    "exact_snippets": "diseases that are planned to be treated with systemic corticosteroids",
                    "criterion": "treatment with systemic corticosteroids",
                    "requirements": [
                        {
                            "requirement_type": "planned treatment",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "diseases that are planned to be treated with ... other immunosuppressive drugs",
                    "criterion": "treatment with other immunosuppressive drugs",
                    "requirements": [
                        {
                            "requirement_type": "planned treatment",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior treatment with cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) inhibitor combined with programmed cell death protein-1 (PD-1) inhibitor, or CTLA-4 inhibitor combined with PD-L1 inhibitor.",
            "criterions": [
                {
                    "exact_snippets": "Prior treatment with cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) inhibitor combined with programmed cell death protein-1 (PD-1) inhibitor",
                    "criterion": "prior treatment with CTLA-4 inhibitor and PD-1 inhibitor",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior treatment with cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) inhibitor combined with ... PD-L1 inhibitor",
                    "criterion": "prior treatment with CTLA-4 inhibitor and PD-L1 inhibitor",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Had received chemotherapy, targeted therapy, biotherapy, endocrine therapy, immunotherapy and other anti-tumor treatments within 4 weeks before the first use of experimental drugs",
            "criterions": [
                {
                    "exact_snippets": "Had received chemotherapy ... within 4 weeks before the first use of experimental drugs",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "recency",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Had received ... targeted therapy ... within 4 weeks before the first use of experimental drugs",
                    "criterion": "targeted therapy",
                    "requirements": [
                        {
                            "requirement_type": "recency",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Had received ... biotherapy ... within 4 weeks before the first use of experimental drugs",
                    "criterion": "biotherapy",
                    "requirements": [
                        {
                            "requirement_type": "recency",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Had received ... endocrine therapy ... within 4 weeks before the first use of experimental drugs",
                    "criterion": "endocrine therapy",
                    "requirements": [
                        {
                            "requirement_type": "recency",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Had received ... immunotherapy ... within 4 weeks before the first use of experimental drugs",
                    "criterion": "immunotherapy",
                    "requirements": [
                        {
                            "requirement_type": "recency",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Had received ... other anti-tumor treatments within 4 weeks before the first use of experimental drugs",
                    "criterion": "other anti-tumor treatments",
                    "requirements": [
                        {
                            "requirement_type": "recency",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "* Subjects with positive antibodies to HIV;Treponema pallidum antibody positive;HBsAg positive patients with VIRAL DEoxy ribonucleic acid (HBV DNA) >2000 IU/ mL or 10^4 copy number/mL should receive antiviral therapy according to local treatment guidelines and be willing to receive antiviral therapy throughout the study period.Hepatitis C virus antibody positive and viral ribonucleic acid (HCV RNA) positive",
            "criterions": [
                {
                    "exact_snippets": "positive antibodies to HIV",
                    "criterion": "HIV antibodies",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Treponema pallidum antibody positive",
                    "criterion": "Treponema pallidum antibodies",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "HBsAg positive",
                    "criterion": "HBsAg",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "HBV DNA >2000 IU/ mL or 10^4 copy number/mL",
                    "criterion": "HBV DNA",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">",
                                        "value": 2000,
                                        "unit": "IU/mL"
                                    },
                                    {
                                        "operator": ">",
                                        "value": 10000,
                                        "unit": "copy number/mL"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Hepatitis C virus antibody positive",
                    "criterion": "Hepatitis C virus antibodies",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "HCV RNA positive",
                    "criterion": "HCV RNA",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}