{
    "info": {
        "nct_id": "NCT05766527",
        "official_title": "A Phase 1 Safety and Tolerability Study of KM602 in Patients With Advanced Solid Tumors",
        "inclusion_criteria": "1. Histologically confirmed, disease that is unresectable, locally advanced, or metastatic and has progressed following all standard treatments or is not appropriate for standard treatments (predominantly melanoma and non-small cell lung cancer)\n2. All patients must have at least one measurable lesion at baseline according to RECIST v1.1\n3. ECOG performance status of 0 or 1\n4. Life expectancy of ≥ 12 weeks\n5. Adequate baseline hematologic, renal, and hepatic function\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
        "exclusion_criteria": "1. Patients with meningeal metastasis or symptomatic central nervous system metastasis\n2. Any second malignancy active within the previous 5 years\n3. Any active, known, or suspected autoimmune disease\n4. Active or prior pneumonitis or interstitial lung disease\n5. Prior organ allograft or allogeneic hematopoietic stem cell transplantation\n6. Treatment with any anti-cancer therapy or participation in another investigational drug or biologics trial within 4 weeks prior to the first dose of KM602\n7. Prior treatment with a CTLA-4 antagonist, including ipilimumab and tremelimumab\n8. History of ≥ Grade 3 immune-related adverse event leading to treatment discontinuation\n9. Systemic treatment with corticosteroids (> 10 mg/day prednisone) or other immunosuppressive medication within 14 days prior to the first dose of KM602 or during the study\n10. Known seropositivity for or active infection by human immunodeficiency virus, hepatitis B or C\n11. Known allergies, hypersensitivity, or intolerance to KM602 or excipients in the drug product formulation\n12. Active infection requiring therapy at the time of the first dose of KM602\n13. Pregnancy or breastfeeding\n14. Any serious or uncontrolled health condition, which, in the opinion of the Investigator, would place the subject at undue risk from the study, impair the ability of the subject to receive protocol specified therapy, or interfere with the interpretation of study results.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Histologically confirmed, disease that is unresectable, locally advanced, or metastatic and has progressed following all standard treatments or is not appropriate for standard treatments (predominantly melanoma and non-small cell lung cancer)",
            "criterions": [
                {
                    "exact_snippets": "Histologically confirmed",
                    "criterion": "disease confirmation",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "histologically"
                        }
                    ]
                },
                {
                    "exact_snippets": "disease that is unresectable",
                    "criterion": "disease resectability",
                    "requirements": [
                        {
                            "requirement_type": "resectability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "disease that is ... locally advanced",
                    "criterion": "disease stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "locally advanced"
                        }
                    ]
                },
                {
                    "exact_snippets": "disease that is ... metastatic",
                    "criterion": "disease stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "metastatic"
                        }
                    ]
                },
                {
                    "exact_snippets": "disease that ... has progressed following all standard treatments",
                    "criterion": "disease progression",
                    "requirements": [
                        {
                            "requirement_type": "progression after treatment",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "disease that ... is not appropriate for standard treatments",
                    "criterion": "appropriateness for standard treatments",
                    "requirements": [
                        {
                            "requirement_type": "appropriateness",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "predominantly melanoma and non-small cell lung cancer",
                    "criterion": "disease type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "melanoma",
                                "non-small cell lung cancer"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. All patients must have at least one measurable lesion at baseline according to RECIST v1.1",
            "criterions": [
                {
                    "exact_snippets": "at least one measurable lesion",
                    "criterion": "measurable lesion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "lesion"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "at baseline",
                    "criterion": "baseline",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "according to RECIST v1.1",
                    "criterion": "RECIST v1.1",
                    "requirements": [
                        {
                            "requirement_type": "compliance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. ECOG performance status of 0 or 1",
            "criterions": [
                {
                    "exact_snippets": "ECOG performance status of 0 or 1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Life expectancy of ≥ 12 weeks",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy of ≥ 12 weeks",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Adequate baseline hematologic, renal, and hepatic function",
            "criterions": [
                {
                    "exact_snippets": "Adequate baseline hematologic ... function",
                    "criterion": "hematologic function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate baseline ... renal ... function",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate baseline ... hepatic function",
                    "criterion": "hepatic function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 75 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 75 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 75,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Patients with meningeal metastasis or symptomatic central nervous system metastasis",
            "criterions": [
                {
                    "exact_snippets": "Patients with meningeal metastasis",
                    "criterion": "meningeal metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "symptomatic central nervous system metastasis",
                    "criterion": "symptomatic central nervous system metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Any second malignancy active within the previous 5 years",
            "criterions": [
                {
                    "exact_snippets": "Any second malignancy active within the previous 5 years",
                    "criterion": "second malignancy",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Any active, known, or suspected autoimmune disease",
            "criterions": [
                {
                    "exact_snippets": "active, known, or suspected autoimmune disease",
                    "criterion": "autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "active",
                                "known",
                                "suspected"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Active or prior pneumonitis or interstitial lung disease",
            "criterions": [
                {
                    "exact_snippets": "Active or prior pneumonitis",
                    "criterion": "pneumonitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Active or prior ... interstitial lung disease",
                    "criterion": "interstitial lung disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Prior organ allograft or allogeneic hematopoietic stem cell transplantation",
            "criterions": [
                {
                    "exact_snippets": "Prior organ allograft",
                    "criterion": "organ allograft",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "allogeneic hematopoietic stem cell transplantation",
                    "criterion": "allogeneic hematopoietic stem cell transplantation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Treatment with any anti-cancer therapy or participation in another investigational drug or biologics trial within 4 weeks prior to the first dose of KM602",
            "criterions": [
                {
                    "exact_snippets": "Treatment with any anti-cancer therapy ... within 4 weeks prior to the first dose of KM602",
                    "criterion": "anti-cancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "participation in another investigational drug or biologics trial within 4 weeks prior to the first dose of KM602",
                    "criterion": "participation in another investigational drug or biologics trial",
                    "requirements": [
                        {
                            "requirement_type": "time since last participation",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Prior treatment with a CTLA-4 antagonist, including ipilimumab and tremelimumab",
            "criterions": [
                {
                    "exact_snippets": "Prior treatment with a CTLA-4 antagonist, including ipilimumab and tremelimumab",
                    "criterion": "prior treatment with CTLA-4 antagonist",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. History of ≥ Grade 3 immune-related adverse event leading to treatment discontinuation",
            "criterions": [
                {
                    "exact_snippets": "History of ≥ Grade 3 immune-related adverse event",
                    "criterion": "immune-related adverse event",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "Grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "leading to treatment discontinuation",
                    "criterion": "treatment discontinuation",
                    "requirements": [
                        {
                            "requirement_type": "cause",
                            "expected_value": "immune-related adverse event"
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Systemic treatment with corticosteroids (> 10 mg/day prednisone) or other immunosuppressive medication within 14 days prior to the first dose of KM602 or during the study",
            "criterions": [
                {
                    "exact_snippets": "Systemic treatment with corticosteroids (> 10 mg/day prednisone)",
                    "criterion": "systemic corticosteroid treatment",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 10,
                                "unit": "mg/day prednisone"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "other immunosuppressive medication within 14 days prior to the first dose of KM602",
                    "criterion": "immunosuppressive medication",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 14 days prior to the first dose of KM602"
                        }
                    ]
                },
                {
                    "exact_snippets": "other immunosuppressive medication ... during the study",
                    "criterion": "immunosuppressive medication",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "during the study"
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Known allergies, hypersensitivity, or intolerance to KM602 or excipients in the drug product formulation",
            "criterions": [
                {
                    "exact_snippets": "Known allergies, hypersensitivity, or intolerance to KM602",
                    "criterion": "allergies, hypersensitivity, or intolerance to KM602",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Known allergies, hypersensitivity, or intolerance to ... excipients in the drug product formulation",
                    "criterion": "allergies, hypersensitivity, or intolerance to excipients in the drug product formulation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Active infection requiring therapy at the time of the first dose of KM602",
            "criterions": [
                {
                    "exact_snippets": "Active infection requiring therapy",
                    "criterion": "active infection",
                    "requirements": [
                        {
                            "requirement_type": "therapy requirement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "at the time of the first dose of KM602",
                    "criterion": "timing of infection",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "at the time of the first dose of KM602"
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. Pregnancy or breastfeeding",
            "criterions": [
                {
                    "exact_snippets": "Pregnancy",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breastfeeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "14. Any serious or uncontrolled health condition, which, in the opinion of the Investigator, would place the subject at undue risk from the study, impair the ability of the subject to receive protocol specified therapy, or interfere with the interpretation of study results.",
            "criterions": [
                {
                    "exact_snippets": "serious or uncontrolled health condition",
                    "criterion": "health condition",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        },
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "10. Known seropositivity for or active infection by human immunodeficiency virus, hepatitis B or C",
            "criterions": [
                {
                    "exact_snippets": "Known seropositivity for ... human immunodeficiency virus",
                    "criterion": "human immunodeficiency virus seropositivity",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "active infection by human immunodeficiency virus",
                    "criterion": "active human immunodeficiency virus infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Known seropositivity for ... hepatitis B",
                    "criterion": "hepatitis B seropositivity",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "active infection by ... hepatitis B",
                    "criterion": "active hepatitis B infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Known seropositivity for ... hepatitis C",
                    "criterion": "hepatitis C seropositivity",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "active infection by ... hepatitis C",
                    "criterion": "active hepatitis C infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}