{
    "info": {
        "nct_id": "NCT06289894",
        "official_title": "A Phase I, Open-label, Single Arm Study to Evaluate the Safety, Tolerability, and Antitumor Activity of BRY805 in Participants With Advanced Solid Tumors",
        "inclusion_criteria": "* 1. Willing and able to provide signed informed and to comply with all study procedures; 2. Male or female ≥ 18 years; 3. Advanced malignant solid tumor patients who have experienced treatment failure using established therapeutic methods, have no viable standard treatment options available, or are unable to tolerate standard therapy; 4. ECOG score ≤ 1; 5. Life expectancy ≥ 3 months; 6. Considering that the phase I trial mainly evaluates the safety and tolerability of the drug, subjects who cannot measure the lesion can be enrolled in the dose escalation phase to obtain more safety, pharmacokinetic and pharmacodynamic results. Enrolled subjects who may have been expanded at 1-3 doses that may have been selected in the early period, have at least one measurable lesion in the baseline period according to RECIST v1.1; 7. Recovery, to Grade 0-1, from adverse events related to prior anticancer therapy except alopecia, < Grade 2 sensory neuropathy and endocrinopathies controlled with hormone replacement therapy; 8. Sufficient organ and bone marrow function; 9. Female subjects of childbearing age must have a negative serum pregnancy test result when they enter this study (tested within 1 week before the first dose); Female subjects of childbearing potential or male subjects whose sexual partner is a female of childbearing age, who are willing to use appropriate and effective contraceptive measures such as abstinence and double barrier methods (such as condoms plus contraceptive diaphragms), oral contraceptives, intrauterine device insertion, etc., during the study period and within 6 months after the last dose.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* 1. Hypersensitivity to study drug or components of its formulation; or have had a severe allergic reaction to other monoclonal antibodies; 2. Prior treatment with NKG2A-targeted agents; 3. Participants will be excluded if they meet any of the following criteria:\n\n  * Major surgery within 4 weeks prior to the first dose, or anticipated major surgery during the study, minor surgery within 2 weeks prior to the first dose;\n\n    * Use of immunosuppressive medications within 2 weeks prior to the first dose; nasal and inhaled corticosteroids or physiologic doses of systemic steroids (i.e., no more than 10 mg/day of prednisone or equivalent pharmacophysiological doses of other corticosteroids) are allowed in the absence of active autoimmune disease;\n\n      * Live vaccine administration within 4 weeks prior to the first dose, at any time during the study, or within 1 month after the last dose; ④ Received anti-tumor therapy (including chemotherapy, radiotherapy, immunotherapy, endocrine therapy, targeted therapy, biological therapy, or tumor embolization) within 5 half-lives or 4 weeks (whichever is shorter) prior to the first dose, or used therapeutic radiopharmaceuticals (strontium, samarium, etc.) within 8 weeks prior to the first dose; ⑤ Participation in other clinical trials within 4 weeks prior to the first dose.\n\n        4. Active autoimmune disease or history of autoimmune disease that may recur, including but not limited to systemic lupus erythematosus, psoriasis, rheumatoid arthritis, inflammatory bowel disease, Hashimoto's thyroiditis, etc. Except for conditions that require only alternative therapy (e.g., residual hypothyroidism due to autoimmune thyroiditis); 5. Symptomatic central nervous system metastases. Asymptomatic patients with CNS metastases who are radiographically and neurologically stable ≥for 4 weeks after CNS-directed therapy and are on stable or reduced doses of corticosteroids are eligible for study entry; 6. History of any malignancy within the past 5 years, with the exception of cured cervical carcinoma in situbasal, basal cell or squamous epithelial cell carcinoma of the skin, localized prostate cancer, ductal carcinoma in situ of the breast, or other malignancies that have been previously treated and judged by the investigator to have stable disease status; 7. Active HIV, hepatitis B or hepatitis C virus. A positive TP specific antibody test requires testing for syphilis non-specific antibodies; 8. Severe cardiovascular disease, including CVA, TIA, myocardial infarction, or unstable angina within 6 months of study entry; NYHA class III or IV heart failure within 6 months of study entry; Uncontrolled arrhythmia within 6 months of study entry; 9. QTcF interval ≥ 470 ms; 10. Uncontrolled hypertension (systolic blood pressure >160 mmHg and diastolic blood pressure >100 mmHg), a history of hypertension crisis, or a history of hypertensive encephalopathy; 11. Active infection requiring intravenous therapy within 2 weeks prior to the first dose; 12. Active tuberculosis, or anti-tuberculosis therapy within 1 year prior to screening; 13. Interstitial lung disease, such as interstitial pneumonia, pulmonary fibrosis, etc., or non-infectious pneumonia; 14. Diseases affecting intravenous infusion and venous blood collection; 15. Has bleeding tendencies or is receiving thrombolytic or anticoagulant therapy; 16. History of allogeneic organ or stem cell transplantation; 17. History of prior grade 3-4 immune-related adverse events or immune-related adverse events requiring discontinuation of treatment; 18. Has a known or suspected condition that is incapable of complying with the study protocol (such as a history of psychotropic substance abuse, alcohol dependence, psychological disorder, or drug abuse); 19. Participants considered unsuitable for inclusion or who may not be able to complete the study for other reasons by the investigator.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "Healthy volunteers allowed",
                "criterions": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have minimum age of 18 Years",
                "criterions": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "* 1. Hypersensitivity to study drug or components of its formulation; or have had a severe allergic reaction to other monoclonal antibodies; 2. Prior treatment with NKG2A-targeted agents; 3. Participants will be excluded if they meet any of the following criteria:",
                "criterions": [
                    {
                        "exact_snippets": "Hypersensitivity to study drug or components of its formulation",
                        "criterion": "hypersensitivity",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "severe allergic reaction to other monoclonal antibodies",
                        "criterion": "severe allergic reaction to monoclonal antibodies",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Prior treatment with NKG2A-targeted agents",
                        "criterion": "prior treatment with NKG2A-targeted agents",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "Hypersensitivity to study drug or components of its formulation",
                                "criterion": "hypersensitivity",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "severe allergic reaction to other monoclonal antibodies",
                                "criterion": "severe allergic reaction to monoclonal antibodies",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "Prior treatment with NKG2A-targeted agents",
                        "criterion": "prior treatment with NKG2A-targeted agents",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Use of immunosuppressive medications within 2 weeks prior to the first dose; nasal and inhaled corticosteroids or physiologic doses of systemic steroids (i.e., no more than 10 mg/day of prednisone or equivalent pharmacophysiological doses of other corticosteroids) are allowed in the absence of active autoimmune disease;",
                "criterions": [
                    {
                        "exact_snippets": "Use of immunosuppressive medications within 2 weeks prior to the first dose",
                        "criterion": "use of immunosuppressive medications",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": "within 2 weeks prior to the first dose"
                        }
                    },
                    {
                        "exact_snippets": "nasal and inhaled corticosteroids or physiologic doses of systemic steroids ... are allowed",
                        "criterion": "use of nasal and inhaled corticosteroids or physiologic doses of systemic steroids",
                        "requirement": {
                            "requirement_type": "allowance",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "no more than 10 mg/day of prednisone or equivalent pharmacophysiological doses of other corticosteroids",
                        "criterion": "dose of systemic steroids",
                        "requirement": {
                            "requirement_type": "maximum dose",
                            "expected_value": {
                                "operator": "<=",
                                "value": 10,
                                "unit": "mg/day"
                            }
                        }
                    },
                    {
                        "exact_snippets": "in the absence of active autoimmune disease",
                        "criterion": "active autoimmune disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "not_criteria": {
                            "and_criteria": [
                                {
                                    "exact_snippets": "Use of immunosuppressive medications within 2 weeks prior to the first dose",
                                    "criterion": "use of immunosuppressive medications",
                                    "requirement": {
                                        "requirement_type": "time frame",
                                        "expected_value": "within 2 weeks prior to the first dose"
                                    }
                                },
                                {
                                    "not_criteria": {
                                        "exact_snippets": "nasal and inhaled corticosteroids or physiologic doses of systemic steroids ... are allowed",
                                        "criterion": "use of nasal and inhaled corticosteroids or physiologic doses of systemic steroids",
                                        "requirement": {
                                            "requirement_type": "allowance",
                                            "expected_value": true
                                        }
                                    }
                                },
                                {
                                    "not_criteria": {
                                        "exact_snippets": "no more than 10 mg/day of prednisone or equivalent pharmacophysiological doses of other corticosteroids",
                                        "criterion": "dose of systemic steroids",
                                        "requirement": {
                                            "requirement_type": "maximum dose",
                                            "expected_value": {
                                                "operator": "<=",
                                                "value": 10,
                                                "unit": "mg/day"
                                            }
                                        }
                                    }
                                },
                                {
                                    "not_criteria": {
                                        "exact_snippets": "in the absence of active autoimmune disease",
                                        "criterion": "active autoimmune disease",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": false
                                        }
                                    }
                                }
                            ]
                        }
                    }
                ]
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "identified_line": {
                "line": "* 1. Willing and able to provide signed informed and to comply with all study procedures; 2. Male or female ≥ 18 years; 3. Advanced malignant solid tumor patients who have experienced treatment failure using established therapeutic methods, have no viable standard treatment options available, or are unable to tolerate standard therapy; 4. ECOG score ≤ 1; 5. Life expectancy ≥ 3 months; 6. Considering that the phase I trial mainly evaluates the safety and tolerability of the drug, subjects who cannot measure the lesion can be enrolled in the dose escalation phase to obtain more safety, pharmacokinetic and pharmacodynamic results. Enrolled subjects who may have been expanded at 1-3 doses that may have been selected in the early period, have at least one measurable lesion in the baseline period according to RECIST v1.1; 7. Recovery, to Grade 0-1, from adverse events related to prior anticancer therapy except alopecia, < Grade 2 sensory neuropathy and endocrinopathies controlled with hormone replacement therapy; 8. Sufficient organ and bone marrow function; 9. Female subjects of childbearing age must have a negative serum pregnancy test result when they enter this study (tested within 1 week before the first dose); Female subjects of childbearing potential or male subjects whose sexual partner is a female of childbearing age, who are willing to use appropriate and effective contraceptive measures such as abstinence and double barrier methods (such as condoms plus contraceptive diaphragms), oral contraceptives, intrauterine device insertion, etc., during the study period and within 6 months after the last dose.",
                "criterions": [
                    {
                        "exact_snippets": "Willing and able to provide signed informed",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Willing and able to provide signed informed",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "comply with all study procedures",
                        "criterion": "compliance with study procedures",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Male or female ≥ 18 years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Advanced malignant solid tumor patients",
                        "criterion": "advanced malignant solid tumor",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "treatment failure using established therapeutic methods",
                        "criterion": "treatment failure",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "failure"
                        }
                    },
                    {
                        "exact_snippets": "no viable standard treatment options available",
                        "criterion": "viable standard treatment options",
                        "requirement": {
                            "requirement_type": "availability",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "unable to tolerate standard therapy",
                        "criterion": "tolerance to standard therapy",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "ECOG score ≤ 1",
                        "criterion": "ECOG score",
                        "requirement": {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Life expectancy ≥ 3 months",
                        "criterion": "life expectancy",
                        "requirement": {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    },
                    {
                        "exact_snippets": "subjects who cannot measure the lesion can be enrolled in the dose escalation phase",
                        "criterion": "measurable lesion",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "at least one measurable lesion in the baseline period according to RECIST v1.1",
                        "criterion": "measurable lesion",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Recovery, to Grade 0-1, from adverse events related to prior anticancer therapy",
                        "criterion": "recovery from adverse events",
                        "requirement": {
                            "requirement_type": "grade",
                            "expected_value": {
                                "operator": "=",
                                "value": 0,
                                "unit": "N/A"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Recovery, to Grade 0-1, from adverse events related to prior anticancer therapy",
                        "criterion": "recovery from adverse events",
                        "requirement": {
                            "requirement_type": "grade",
                            "expected_value": {
                                "operator": "=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    },
                    {
                        "exact_snippets": "except alopecia, < Grade 2 sensory neuropathy and endocrinopathies controlled with hormone replacement therapy",
                        "criterion": "adverse events exceptions",
                        "requirement": {
                            "requirement_type": "exceptions",
                            "expected_value": [
                                "alopecia",
                                "< Grade 2 sensory neuropathy",
                                "endocrinopathies controlled with hormone replacement therapy"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "Sufficient organ and bone marrow function",
                        "criterion": "organ and bone marrow function",
                        "requirement": {
                            "requirement_type": "sufficiency",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Female subjects of childbearing age must have a negative serum pregnancy test result",
                        "criterion": "serum pregnancy test",
                        "requirement": {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    },
                    {
                        "exact_snippets": "Female subjects of childbearing potential or male subjects whose sexual partner is a female of childbearing age, who are willing to use appropriate and effective contraceptive measures",
                        "criterion": "contraceptive measures",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        }
    ],
    "failed_exclusion": [
        {
            "identified_line": {
                "line": "* Major surgery within 4 weeks prior to the first dose, or anticipated major surgery during the study, minor surgery within 2 weeks prior to the first dose;",
                "criterions": [
                    {
                        "exact_snippets": "Major surgery within 4 weeks prior to the first dose",
                        "criterion": "major surgery",
                        "requirement": {
                            "requirement_type": "time since surgery",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "anticipated major surgery during the study",
                        "criterion": "anticipated major surgery",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "minor surgery within 2 weeks prior to the first dose",
                        "criterion": "minor surgery",
                        "requirement": {
                            "requirement_type": "time since surgery",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Major surgery within 4 weeks prior to the first dose",
                                "criterion": "major surgery",
                                "requirement": {
                                    "requirement_type": "time since surgery",
                                    "expected_value": {
                                        "operator": "<",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "anticipated major surgery during the study",
                        "criterion": "anticipated major surgery",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "minor surgery within 2 weeks prior to the first dose",
                                "criterion": "minor surgery",
                                "requirement": {
                                    "requirement_type": "time since surgery",
                                    "expected_value": {
                                        "operator": "<",
                                        "value": 2,
                                        "unit": "weeks"
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Live vaccine administration within 4 weeks prior to the first dose, at any time during the study, or within 1 month after the last dose; ④ Received anti-tumor therapy (including chemotherapy, radiotherapy, immunotherapy, endocrine therapy, targeted therapy, biological therapy, or tumor embolization) within 5 half-lives or 4 weeks (whichever is shorter) prior to the first dose, or used therapeutic radiopharmaceuticals (strontium, samarium, etc.) within 8 weeks prior to the first dose; ⑤ Participation in other clinical trials within 4 weeks prior to the first dose.",
                "criterions": [
                    {
                        "exact_snippets": "Live vaccine administration within 4 weeks prior to the first dose, at any time during the study, or within 1 month after the last dose",
                        "criterion": "live vaccine administration",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": "within 4 weeks prior to the first dose, at any time during the study, or within 1 month after the last dose"
                        }
                    },
                    {
                        "exact_snippets": "Received anti-tumor therapy (including chemotherapy, radiotherapy, immunotherapy, endocrine therapy, targeted therapy, biological therapy, or tumor embolization) within 5 half-lives or 4 weeks (whichever is shorter) prior to the first dose",
                        "criterion": "anti-tumor therapy",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": "within 5 half-lives or 4 weeks (whichever is shorter) prior to the first dose"
                        }
                    },
                    {
                        "exact_snippets": "used therapeutic radiopharmaceuticals (strontium, samarium, etc.) within 8 weeks prior to the first dose",
                        "criterion": "therapeutic radiopharmaceuticals",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": "within 8 weeks prior to the first dose"
                        }
                    },
                    {
                        "exact_snippets": "Participation in other clinical trials within 4 weeks prior to the first dose",
                        "criterion": "participation in other clinical trials",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": "within 4 weeks prior to the first dose"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "or_criteria": [
                                    {
                                        "exact_snippets": "Live vaccine administration within 4 weeks prior to the first dose, at any time during the study, or within 1 month after the last dose",
                                        "criterion": "live vaccine administration",
                                        "requirement": {
                                            "requirement_type": "timing",
                                            "expected_value": "within 4 weeks prior to the first dose"
                                        }
                                    },
                                    {
                                        "exact_snippets": "Live vaccine administration within 4 weeks prior to the first dose, at any time during the study, or within 1 month after the last dose",
                                        "criterion": "live vaccine administration",
                                        "requirement": {
                                            "requirement_type": "timing",
                                            "expected_value": "at any time during the study"
                                        }
                                    },
                                    {
                                        "exact_snippets": "Live vaccine administration within 4 weeks prior to the first dose, at any time during the study, or within 1 month after the last dose",
                                        "criterion": "live vaccine administration",
                                        "requirement": {
                                            "requirement_type": "timing",
                                            "expected_value": "within 1 month after the last dose"
                                        }
                                    }
                                ]
                            },
                            {
                                "or_criteria": [
                                    {
                                        "exact_snippets": "Received anti-tumor therapy (including chemotherapy, radiotherapy, immunotherapy, endocrine therapy, targeted therapy, biological therapy, or tumor embolization) within 5 half-lives or 4 weeks (whichever is shorter) prior to the first dose",
                                        "criterion": "anti-tumor therapy",
                                        "requirement": {
                                            "requirement_type": "timing",
                                            "expected_value": "within 5 half-lives prior to the first dose"
                                        }
                                    },
                                    {
                                        "exact_snippets": "Received anti-tumor therapy (including chemotherapy, radiotherapy, immunotherapy, endocrine therapy, targeted therapy, biological therapy, or tumor embolization) within 5 half-lives or 4 weeks (whichever is shorter) prior to the first dose",
                                        "criterion": "anti-tumor therapy",
                                        "requirement": {
                                            "requirement_type": "timing",
                                            "expected_value": "within 4 weeks prior to the first dose"
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "used therapeutic radiopharmaceuticals (strontium, samarium, etc.) within 8 weeks prior to the first dose",
                                "criterion": "therapeutic radiopharmaceuticals",
                                "requirement": {
                                    "requirement_type": "timing",
                                    "expected_value": "within 8 weeks prior to the first dose"
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "Participation in other clinical trials within 4 weeks prior to the first dose",
                        "criterion": "participation in other clinical trials",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": "within 4 weeks prior to the first dose"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "4. Active autoimmune disease or history of autoimmune disease that may recur, including but not limited to systemic lupus erythematosus, psoriasis, rheumatoid arthritis, inflammatory bowel disease, Hashimoto's thyroiditis, etc. Except for conditions that require only alternative therapy (e.g., residual hypothyroidism due to autoimmune thyroiditis); 5. Symptomatic central nervous system metastases. Asymptomatic patients with CNS metastases who are radiographically and neurologically stable ≥for 4 weeks after CNS-directed therapy and are on stable or reduced doses of corticosteroids are eligible for study entry; 6. History of any malignancy within the past 5 years, with the exception of cured cervical carcinoma in situbasal, basal cell or squamous epithelial cell carcinoma of the skin, localized prostate cancer, ductal carcinoma in situ of the breast, or other malignancies that have been previously treated and judged by the investigator to have stable disease status; 7. Active HIV, hepatitis B or hepatitis C virus. A positive TP specific antibody test requires testing for syphilis non-specific antibodies; 8. Severe cardiovascular disease, including CVA, TIA, myocardial infarction, or unstable angina within 6 months of study entry; NYHA class III or IV heart failure within 6 months of study entry; Uncontrolled arrhythmia within 6 months of study entry; 9. QTcF interval ≥ 470 ms; 10. Uncontrolled hypertension (systolic blood pressure >160 mmHg and diastolic blood pressure >100 mmHg), a history of hypertension crisis, or a history of hypertensive encephalopathy; 11. Active infection requiring intravenous therapy within 2 weeks prior to the first dose; 12. Active tuberculosis, or anti-tuberculosis therapy within 1 year prior to screening; 13. Interstitial lung disease, such as interstitial pneumonia, pulmonary fibrosis, etc., or non-infectious pneumonia; 14. Diseases affecting intravenous infusion and venous blood collection; 15. Has bleeding tendencies or is receiving thrombolytic or anticoagulant therapy; 16. History of allogeneic organ or stem cell transplantation; 17. History of prior grade 3-4 immune-related adverse events or immune-related adverse events requiring discontinuation of treatment; 18. Has a known or suspected condition that is incapable of complying with the study protocol (such as a history of psychotropic substance abuse, alcohol dependence, psychological disorder, or drug abuse); 19. Participants considered unsuitable for inclusion or who may not be able to complete the study for other reasons by the investigator.",
                "criterions": [
                    {
                        "exact_snippets": "Active autoimmune disease or history of autoimmune disease that may recur",
                        "criterion": "autoimmune disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Symptomatic central nervous system metastases",
                        "criterion": "symptomatic CNS metastases",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Asymptomatic patients with CNS metastases who are radiographically and neurologically stable ≥for 4 weeks after CNS-directed therapy and are on stable or reduced doses of corticosteroids",
                        "criterion": "asymptomatic CNS metastases",
                        "requirement": {
                            "requirement_type": "stability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "History of any malignancy within the past 5 years",
                        "criterion": "malignancy history",
                        "requirement": {
                            "requirement_type": "time since last occurrence",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Active HIV, hepatitis B or hepatitis C virus",
                        "criterion": "active viral infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Severe cardiovascular disease, including CVA, TIA, myocardial infarction, or unstable angina within 6 months of study entry",
                        "criterion": "severe cardiovascular disease",
                        "requirement": {
                            "requirement_type": "time since last occurrence",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    },
                    {
                        "exact_snippets": "NYHA class III or IV heart failure within 6 months of study entry",
                        "criterion": "NYHA class III or IV heart failure",
                        "requirement": {
                            "requirement_type": "time since last occurrence",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Uncontrolled arrhythmia within 6 months of study entry",
                        "criterion": "uncontrolled arrhythmia",
                        "requirement": {
                            "requirement_type": "time since last occurrence",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    },
                    {
                        "exact_snippets": "QTcF interval ≥ 470 ms",
                        "criterion": "QTcF interval",
                        "requirement": {
                            "requirement_type": "length",
                            "expected_value": {
                                "operator": "<",
                                "value": 470,
                                "unit": "ms"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Uncontrolled hypertension (systolic blood pressure >160 mmHg and diastolic blood pressure >100 mmHg)",
                        "criterion": "uncontrolled hypertension",
                        "requirement": {
                            "requirement_type": "systolic blood pressure",
                            "expected_value": {
                                "operator": "<=",
                                "value": 160,
                                "unit": "mmHg"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Uncontrolled hypertension (systolic blood pressure >160 mmHg and diastolic blood pressure >100 mmHg)",
                        "criterion": "uncontrolled hypertension",
                        "requirement": {
                            "requirement_type": "diastolic blood pressure",
                            "expected_value": {
                                "operator": "<=",
                                "value": 100,
                                "unit": "mmHg"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Active infection requiring intravenous therapy within 2 weeks prior to the first dose",
                        "criterion": "active infection requiring IV therapy",
                        "requirement": {
                            "requirement_type": "time since last occurrence",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Active tuberculosis, or anti-tuberculosis therapy within 1 year prior to screening",
                        "criterion": "active tuberculosis or anti-tuberculosis therapy",
                        "requirement": {
                            "requirement_type": "time since last occurrence",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "year"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Interstitial lung disease, such as interstitial pneumonia, pulmonary fibrosis, etc., or non-infectious pneumonia",
                        "criterion": "interstitial lung disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Diseases affecting intravenous infusion and venous blood collection",
                        "criterion": "diseases affecting IV infusion and venous blood collection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Has bleeding tendencies or is receiving thrombolytic or anticoagulant therapy",
                        "criterion": "bleeding tendencies or anticoagulant therapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "History of allogeneic organ or stem cell transplantation",
                        "criterion": "allogeneic organ or stem cell transplantation",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "History of prior grade 3-4 immune-related adverse events or immune-related adverse events requiring discontinuation of treatment",
                        "criterion": "grade 3-4 immune-related adverse events",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Has a known or suspected condition that is incapable of complying with the study protocol (such as a history of psychotropic substance abuse, alcohol dependence, psychological disorder, or drug abuse)",
                        "criterion": "condition affecting compliance with study protocol",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Participants considered unsuitable for inclusion or who may not be able to complete the study for other reasons by the investigator",
                        "criterion": "suitability for study",
                        "requirement": {
                            "requirement_type": "judgment by investigator",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        }
    ],
    "failed_miscellaneous": []
}