{
    "info": {
        "nct_id": "NCT06226766",
        "official_title": "Phase I/II Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of JSKN033 in Patients With Advanced or Metastatic Solid Malignant Tumors",
        "inclusion_criteria": "1. Be willing and able to provide written informed consent form (ICF) for the trial.\n2. Male or female, 18 years of age or older; willing and able to complete all required procedures of study.\n3. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1, and life expectancy ≥ 12 weeks.\n4. Must have a pathologically documented advanced unresectable or metastatic solid malignant tumor (gastrointestinal tumor for dose expansion phase) with HER2 expression (IHC ≥1+) that is refractory to or intolerable with standard treatment, or for which no effective standard treatment is available. HER2 mutation in patients with NSCLC is also regarded as HER2 expression.\n5. Baseline measurable disease according to RECIST 1.1. Target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.\n6. Adequate organ function assessed within 7 days prior to first trial treatment [had not received blood transfusion, erythropoietin (EPO), granulocyte colony stimulating factor (G-CSF) or other relevant medical support within 14 days before the administration of the investigational product].\n7. Have adequate treatment washout period before first dose.\n8. Have LVEF ≥50% by either echo cardiography (ECHO) or multiple-gated acquisition (MUGA) within 28 days prior to first dose.\n9. Female or male patients of childbearing potential should be willing to use a highly effective method of contraception (with a failure rate of less than 1.0% per year) from first study treatment to 180 days after completion of study treatment. Female of childbearing potential should have a negative pregnancy test within 7 days prior to first trial treatment (childbearing potential is defined as premenopausal females without documented tubal ligation or hysterectomy, or postmenopausal females within 1 year).\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Patients with untreated active brain metastases or meningeal or spinal cord metastases are excluded. If the subject has received treatment for brain metastases and the metastases are stable (as evidenced by brain imaging within 28 days prior to study treatment showing stable disease, no new lesions, and no new neurological symptoms, and no requirement for steroids for at least 14 days prior to study treatment), they may be eligible for enrollment.\n2. Concurrent malignancy within 5 years prior to first dose other than adequately treated cervical carcinoma-in-situ, localized squamous cell cancer of the skin, basal cell carcinoma, prostate cancer, thyroid cancer not requiring treatment, ductal carcinoma in situ of the breast, or < T1 urothelial carcinoma.\n3. Prior treatment with an antibody-drug conjugate (ADC) which consists of a topoisomerase I inhibitor derivative.\n4. History of uncontrolled concurrent illness.\n5. Has a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids or current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by image at screening.\n6. Previous severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) infection either suspected or confirmed within 4 weeks prior to screening. Acute symptoms will be excluded, or must have resolved and based on investigator assessment, there are no sequela that would place participant at a higher risk of receiving investigational treatment.\n7. Patients with ascites, pleural effusion, pericardial effusion which cannot be controlled by appropriate interventions.\n8. Have unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia, grade 2 hypoparathyroidism) related to prior anticancer therapy and stable anemia not yet resolved to grade ≤ 1 (NCI-CTCAEV5.0).\n9. Patients with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids, and adrenal replacement doses ≤ 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. A brief course of corticosteroids for the prophylaxis (e.g., contrast dye allergy) or treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by contact allergen) is permitted.\n10. History of life-threatening hypersensitivity or known to be allergic to protein drugs or recombinant proteins or excipients in JSKN033 drug formulation.\n11. Prior history of anti-HER2 therapy induced angioedema, or severe hypotension and Severe allergic reactions to other antibody drugs or topoisomerase I inhibitors.\n12. Other conditions that, in the investigators' opinion, would make patients inappropriate to participate in this study, such as a history of mental illness, alcoholism or drug abuse.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Be willing and able to provide written informed consent form (ICF) for the trial.",
            "criterions": [
                {
                    "exact_snippets": "willing and able to provide written informed consent form (ICF)",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Male or female, 18 years of age or older; willing and able to complete all required procedures of study.",
            "criterions": [
                {
                    "exact_snippets": "Male or female",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "18 years of age or older",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "willing and able to complete all required procedures of study",
                    "criterion": "willingness and ability to complete study procedures",
                    "requirements": [
                        {
                            "requirement_type": "willingness and ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1, and life expectancy ≥ 12 weeks.",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "life expectancy ≥ 12 weeks",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Must have a pathologically documented advanced unresectable or metastatic solid malignant tumor (gastrointestinal tumor for dose expansion phase) with HER2 expression (IHC ≥1+) that is refractory to or intolerable with standard treatment, or for which no effective standard treatment is available. HER2 mutation in patients with NSCLC is also regarded as HER2 expression.",
            "criterions": [
                {
                    "exact_snippets": "pathologically documented advanced unresectable or metastatic solid malignant tumor",
                    "criterion": "solid malignant tumor",
                    "requirements": [
                        {
                            "requirement_type": "documentation",
                            "expected_value": "pathologically documented"
                        },
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "advanced",
                                "unresectable",
                                "metastatic"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "gastrointestinal tumor for dose expansion phase",
                    "criterion": "gastrointestinal tumor",
                    "requirements": [
                        {
                            "requirement_type": "phase",
                            "expected_value": "dose expansion"
                        }
                    ]
                },
                {
                    "exact_snippets": "HER2 expression (IHC ≥1+)",
                    "criterion": "HER2 expression",
                    "requirements": [
                        {
                            "requirement_type": "IHC score",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "+"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "refractory to or intolerable with standard treatment",
                    "criterion": "standard treatment",
                    "requirements": [
                        {
                            "requirement_type": "response",
                            "expected_value": [
                                "refractory",
                                "intolerable"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "no effective standard treatment is available",
                    "criterion": "effective standard treatment",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "HER2 mutation in patients with NSCLC is also regarded as HER2 expression",
                    "criterion": "HER2 mutation in NSCLC",
                    "requirements": [
                        {
                            "requirement_type": "regard as",
                            "expected_value": "HER2 expression"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Baseline measurable disease according to RECIST 1.1. Target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.",
            "criterions": [
                {
                    "exact_snippets": "Baseline measurable disease according to RECIST 1.1.",
                    "criterion": "measurable disease",
                    "requirements": [
                        {
                            "requirement_type": "baseline",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "standard",
                            "expected_value": "RECIST 1.1"
                        }
                    ]
                },
                {
                    "exact_snippets": "Target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.",
                    "criterion": "target lesions in irradiated area",
                    "requirements": [
                        {
                            "requirement_type": "measurable",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "progression",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Adequate organ function assessed within 7 days prior to first trial treatment [had not received blood transfusion, erythropoietin (EPO), granulocyte colony stimulating factor (G-CSF) or other relevant medical support within 14 days before the administration of the investigational product].",
            "criterions": [
                {
                    "exact_snippets": "Adequate organ function",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "assessed within 7 days prior to first trial treatment",
                    "criterion": "organ function assessment timing",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<=",
                                "value": 7,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "had not received blood transfusion",
                    "criterion": "blood transfusion",
                    "requirements": [
                        {
                            "requirement_type": "receipt",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "had not received ... erythropoietin (EPO)",
                    "criterion": "erythropoietin (EPO)",
                    "requirements": [
                        {
                            "requirement_type": "receipt",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "had not received ... granulocyte colony stimulating factor (G-CSF)",
                    "criterion": "granulocyte colony stimulating factor (G-CSF)",
                    "requirements": [
                        {
                            "requirement_type": "receipt",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "had not received ... other relevant medical support",
                    "criterion": "other relevant medical support",
                    "requirements": [
                        {
                            "requirement_type": "receipt",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "within 14 days before the administration of the investigational product",
                    "criterion": "medical support receipt timing",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Have adequate treatment washout period before first dose.",
            "criterions": [
                {
                    "exact_snippets": "adequate treatment washout period",
                    "criterion": "treatment washout period",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Have LVEF ≥50% by either echo cardiography (ECHO) or multiple-gated acquisition (MUGA) within 28 days prior to first dose.",
            "criterions": [
                {
                    "exact_snippets": "LVEF ≥50%",
                    "criterion": "LVEF",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "%"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "by either echo cardiography (ECHO) or multiple-gated acquisition (MUGA)",
                    "criterion": "method of LVEF measurement",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "echo cardiography (ECHO)",
                                "multiple-gated acquisition (MUGA)"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "within 28 days prior to first dose",
                    "criterion": "timing of LVEF measurement",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 28 days prior to first dose"
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Female or male patients of childbearing potential should be willing to use a highly effective method of contraception (with a failure rate of less than 1.0% per year) from first study treatment to 180 days after completion of study treatment. Female of childbearing potential should have a negative pregnancy test within 7 days prior to first trial treatment (childbearing potential is defined as premenopausal females without documented tubal ligation or hysterectomy, or postmenopausal females within 1 year).",
            "criterions": [
                {
                    "exact_snippets": "Female or male patients of childbearing potential",
                    "criterion": "childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "should be willing to use a highly effective method of contraception",
                    "criterion": "willingness to use contraception",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "(with a failure rate of less than 1.0% per year)",
                    "criterion": "contraception failure rate",
                    "requirements": [
                        {
                            "requirement_type": "failure rate",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.0,
                                "unit": "% per year"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "from first study treatment to 180 days after completion of study treatment",
                    "criterion": "contraception duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "from first study treatment to 180 days after completion of study treatment"
                        }
                    ]
                },
                {
                    "exact_snippets": "Female of childbearing potential should have a negative pregnancy test",
                    "criterion": "pregnancy test result",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "within 7 days prior to first trial treatment",
                    "criterion": "timing of pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 7 days prior to first trial treatment"
                        }
                    ]
                },
                {
                    "exact_snippets": "childbearing potential is defined as premenopausal females without documented tubal ligation or hysterectomy, or postmenopausal females within 1 year",
                    "criterion": "definition of childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "definition",
                            "expected_value": "premenopausal females without documented tubal ligation or hysterectomy, or postmenopausal females within 1 year"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Patients with untreated active brain metastases or meningeal or spinal cord metastases are excluded. If the subject has received treatment for brain metastases and the metastases are stable (as evidenced by brain imaging within 28 days prior to study treatment showing stable disease, no new lesions, and no new neurological symptoms, and no requirement for steroids for at least 14 days prior to study treatment), they may be eligible for enrollment.",
            "criterions": [
                {
                    "exact_snippets": "untreated active brain metastases",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "untreated active"
                        }
                    ]
                },
                {
                    "exact_snippets": "meningeal or spinal cord metastases",
                    "criterion": "meningeal or spinal cord metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "treatment for brain metastases ... metastases are stable",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "treated"
                        },
                        {
                            "requirement_type": "stability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "brain imaging within 28 days prior to study treatment showing stable disease",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "imaging stability",
                            "expected_value": {
                                "operator": "<=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "no new lesions",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "new lesions",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "no new neurological symptoms",
                    "criterion": "neurological symptoms",
                    "requirements": [
                        {
                            "requirement_type": "new symptoms",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "no requirement for steroids for at least 14 days prior to study treatment",
                    "criterion": "steroid requirement",
                    "requirements": [
                        {
                            "requirement_type": "requirement",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Concurrent malignancy within 5 years prior to first dose other than adequately treated cervical carcinoma-in-situ, localized squamous cell cancer of the skin, basal cell carcinoma, prostate cancer, thyroid cancer not requiring treatment, ductal carcinoma in situ of the breast, or < T1 urothelial carcinoma.",
            "criterions": [
                {
                    "exact_snippets": "Concurrent malignancy within 5 years prior to first dose",
                    "criterion": "concurrent malignancy",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "years"
                            }
                        },
                        {
                            "requirement_type": "concurrent",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "adequately treated cervical carcinoma-in-situ",
                    "criterion": "cervical carcinoma-in-situ",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "adequately treated"
                        }
                    ]
                },
                {
                    "exact_snippets": "localized squamous cell cancer of the skin",
                    "criterion": "squamous cell cancer of the skin",
                    "requirements": [
                        {
                            "requirement_type": "localization",
                            "expected_value": "localized"
                        }
                    ]
                },
                {
                    "exact_snippets": "basal cell carcinoma",
                    "criterion": "basal cell carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "prostate cancer",
                    "criterion": "prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "thyroid cancer not requiring treatment",
                    "criterion": "thyroid cancer",
                    "requirements": [
                        {
                            "requirement_type": "treatment requirement",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "ductal carcinoma in situ of the breast",
                    "criterion": "ductal carcinoma in situ of the breast",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "< T1 urothelial carcinoma",
                    "criterion": "urothelial carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": {
                                "operator": "<",
                                "value": 1,
                                "unit": "T"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Prior treatment with an antibody-drug conjugate (ADC) which consists of a topoisomerase I inhibitor derivative.",
            "criterions": [
                {
                    "exact_snippets": "Prior treatment with an antibody-drug conjugate (ADC) which consists of a topoisomerase I inhibitor derivative.",
                    "criterion": "prior treatment with ADC",
                    "requirements": [
                        {
                            "requirement_type": "composition",
                            "expected_value": "topoisomerase I inhibitor derivative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. History of uncontrolled concurrent illness.",
            "criterions": [
                {
                    "exact_snippets": "History of uncontrolled concurrent illness",
                    "criterion": "concurrent illness",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Has a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids or current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by image at screening.",
            "criterions": [
                {
                    "exact_snippets": "Has a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis",
                    "criterion": "history of interstitial lung disease (ILD)/pneumonitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "current ILD/pneumonitis",
                    "criterion": "current interstitial lung disease (ILD)/pneumonitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "suspected ILD/pneumonitis cannot be ruled out by image at screening",
                    "criterion": "suspected interstitial lung disease (ILD)/pneumonitis",
                    "requirements": [
                        {
                            "requirement_type": "rulability by image at screening",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Previous severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) infection either suspected or confirmed within 4 weeks prior to screening. Acute symptoms will be excluded, or must have resolved and based on investigator assessment, there are no sequela that would place participant at a higher risk of receiving investigational treatment.",
            "criterions": [
                {
                    "exact_snippets": "Previous severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) infection either suspected or confirmed within 4 weeks prior to screening",
                    "criterion": "SARS-COV-2 infection",
                    "requirements": [
                        {
                            "requirement_type": "time since infection",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Acute symptoms will be excluded",
                    "criterion": "acute symptoms",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "must have resolved",
                    "criterion": "acute symptoms",
                    "requirements": [
                        {
                            "requirement_type": "resolution",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "no sequela that would place participant at a higher risk of receiving investigational treatment",
                    "criterion": "sequela",
                    "requirements": [
                        {
                            "requirement_type": "risk assessment",
                            "expected_value": "no higher risk"
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Patients with ascites, pleural effusion, pericardial effusion which cannot be controlled by appropriate interventions.",
            "criterions": [
                {
                    "exact_snippets": "Patients with ascites ... which cannot be controlled by appropriate interventions.",
                    "criterion": "ascites",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients with ... pleural effusion ... which cannot be controlled by appropriate interventions.",
                    "criterion": "pleural effusion",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients with ... pericardial effusion which cannot be controlled by appropriate interventions.",
                    "criterion": "pericardial effusion",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Have unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia, grade 2 hypoparathyroidism) related to prior anticancer therapy and stable anemia not yet resolved to grade ≤ 1 (NCI-CTCAEV5.0).",
            "criterions": [
                {
                    "exact_snippets": "unresolved toxicities from previous anticancer therapy",
                    "criterion": "unresolved toxicities from previous anticancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "toxicities (other than alopecia, grade 2 hypoparathyroidism) related to prior anticancer therapy",
                    "criterion": "toxicities related to prior anticancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "other than alopecia, grade 2 hypoparathyroidism"
                        }
                    ]
                },
                {
                    "exact_snippets": "stable anemia not yet resolved to grade ≤ 1 (NCI-CTCAEV5.0)",
                    "criterion": "stable anemia",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "grade (NCI-CTCAEV5.0)"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Patients with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids, and adrenal replacement doses ≤ 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. A brief course of corticosteroids for the prophylaxis (e.g., contrast dye allergy) or treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by contact allergen) is permitted.",
            "criterions": [
                {
                    "exact_snippets": "condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration",
                    "criterion": "systemic treatment with corticosteroids or immunosuppressive medications",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 14 days of study drug administration"
                        },
                        {
                            "requirement_type": "dosage",
                            "expected_value": {
                                "operator": ">",
                                "value": 10,
                                "unit": "mg daily prednisone equivalents"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Inhaled or topical steroids, and adrenal replacement doses ≤ 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease",
                    "criterion": "inhaled or topical steroids, and adrenal replacement doses",
                    "requirements": [
                        {
                            "requirement_type": "dosage",
                            "expected_value": {
                                "operator": "<=",
                                "value": 10,
                                "unit": "mg daily prednisone equivalents"
                            }
                        },
                        {
                            "requirement_type": "condition",
                            "expected_value": "absence of active autoimmune disease"
                        }
                    ]
                },
                {
                    "exact_snippets": "A brief course of corticosteroids for the prophylaxis (e.g., contrast dye allergy) or treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by contact allergen) is permitted",
                    "criterion": "brief course of corticosteroids",
                    "requirements": [
                        {
                            "requirement_type": "purpose",
                            "expected_value": [
                                "prophylaxis",
                                "treatment of non-autoimmune conditions"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. History of life-threatening hypersensitivity or known to be allergic to protein drugs or recombinant proteins or excipients in JSKN033 drug formulation.",
            "criterions": [
                {
                    "exact_snippets": "History of life-threatening hypersensitivity",
                    "criterion": "life-threatening hypersensitivity",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "known to be allergic to protein drugs",
                    "criterion": "allergy to protein drugs",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "known to be allergic to ... recombinant proteins",
                    "criterion": "allergy to recombinant proteins",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "known to be allergic to ... excipients in JSKN033 drug formulation",
                    "criterion": "allergy to excipients in JSKN033 drug formulation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Prior history of anti-HER2 therapy induced angioedema, or severe hypotension and Severe allergic reactions to other antibody drugs or topoisomerase I inhibitors.",
            "criterions": [
                {
                    "exact_snippets": "Prior history of anti-HER2 therapy induced angioedema",
                    "criterion": "anti-HER2 therapy induced angioedema",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "severe hypotension",
                    "criterion": "severe hypotension",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Severe allergic reactions to other antibody drugs",
                    "criterion": "severe allergic reactions to antibody drugs",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Severe allergic reactions to ... topoisomerase I inhibitors",
                    "criterion": "severe allergic reactions to topoisomerase I inhibitors",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Other conditions that, in the investigators' opinion, would make patients inappropriate to participate in this study, such as a history of mental illness, alcoholism or drug abuse.",
            "criterions": [
                {
                    "exact_snippets": "history of mental illness",
                    "criterion": "mental illness",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of ... alcoholism",
                    "criterion": "alcoholism",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of ... drug abuse",
                    "criterion": "drug abuse",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}