{
    "info": {
        "nct_id": "NCT04861948",
        "official_title": "Phase Ib Study to Evaluate the Efficacy, Safety and Tolerability of IBI188 Combination Therapy in Subjects With Advanced Malignancies",
        "inclusion_criteria": "1. Patients with locally advanced or metastatic solid tumors cannot be cured by surgery or other local treatments .\n2. Aged ≥ 18 years (≥ 12 years is acceptable in Cohort C).\n3. Able to provide archived or fresh tumor tissue samples for biomarker assessment.\n4. Have at least one measurable lesion according to RECIST version 1.1.\n5. ECCG PS score of 0-2.\n6. Adequate organ and bone marrow functions .\n7. Life expectancy ≥ 12 weeks.\n8. Female subjects of childbearing potential or male subjects with partners of childbearing potential should take effective contraceptive measures throughout the whole treatment period and until 6 months after treatment.\n9. Must voluntarily sign the Informed Consent Form (ICF), and be able to follow all study requirements and procedures. For the subjects enrolled in Cohort C who are ≥ 12 and < 18 years old, in addition to obtaining the child's own consent, their guardians should provide informed consent and sign the ICF.\nHealthy volunteers allowed\nMust have minimum age of 12 Years",
        "exclusion_criteria": "1. Previous exposure to any CD47 antibody, SIRPα antibody, CD47/SIRPα recombinant protein or other inhibitors that act in the same pathway.\n2. Previous exposure to any anti-programmed death receptor 1 (PD-1) or anti-programmed death-ligand (PD-L1) antibody (except Cohort C).\n3. Concurrent participation in another clinical study.\n4. The last dose of anti-tumor therapy is within 4 weeks before the first dose of study treatment.\n5. Have undergone major surgical procedures within 4 weeks prior to the first dose of study treatment or planned to receive major surgery during the study treatment.\n6. Presence of toxicities (excluding alopecia and fatigue) induced by previous anti-tumor therapy that has not recovered to Grade 0 or 1 as assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 prior to the first dose of study treatment.\n7. Known hypersensitivity to IBI188 or any ingredient in the study drug product.\n8. History of other primary malignancies.\n9. Female subjects who are pregnant or lactating.\n10. Other ineligible conditions considered by the investigator.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Patients with locally advanced or metastatic solid tumors cannot be cured by surgery or other local treatments .",
            "criterions": [
                {
                    "exact_snippets": "locally advanced or metastatic solid tumors",
                    "criterion": "tumor stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "locally advanced",
                                "metastatic"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "cannot be cured by surgery or other local treatments",
                    "criterion": "treatment curability",
                    "requirements": [
                        {
                            "requirement_type": "curability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Aged ≥ 18 years (≥ 12 years is acceptable in Cohort C).",
            "criterions": [
                {
                    "exact_snippets": "Aged ≥ 18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "≥ 12 years is acceptable in Cohort C",
                    "criterion": "age for Cohort C",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Able to provide archived or fresh tumor tissue samples for biomarker assessment.",
            "criterions": [
                {
                    "exact_snippets": "Able to provide archived or fresh tumor tissue samples",
                    "criterion": "tumor tissue samples",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "biomarker assessment",
                    "criterion": "biomarker assessment",
                    "requirements": [
                        {
                            "requirement_type": "purpose",
                            "expected_value": "biomarker assessment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Have at least one measurable lesion according to RECIST version 1.1.",
            "criterions": [
                {
                    "exact_snippets": "at least one measurable lesion according to RECIST version 1.1.",
                    "criterion": "measurable lesion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "lesion"
                            }
                        },
                        {
                            "requirement_type": "measurement standard",
                            "expected_value": "RECIST version 1.1"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. ECCG PS score of 0-2.",
            "criterions": [
                {
                    "exact_snippets": "ECCG PS score of 0-2",
                    "criterion": "ECCG PS score",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Adequate organ and bone marrow functions .",
            "criterions": [
                {
                    "exact_snippets": "Adequate organ ... functions",
                    "criterion": "organ functions",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate ... bone marrow functions",
                    "criterion": "bone marrow functions",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Life expectancy ≥ 12 weeks.",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy ≥ 12 weeks.",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Female subjects of childbearing potential or male subjects with partners of childbearing potential should take effective contraceptive measures throughout the whole treatment period and until 6 months after treatment.",
            "criterions": [
                {
                    "exact_snippets": "Female subjects of childbearing potential",
                    "criterion": "female subjects",
                    "requirements": [
                        {
                            "requirement_type": "childbearing potential",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "male subjects with partners of childbearing potential",
                    "criterion": "male subjects",
                    "requirements": [
                        {
                            "requirement_type": "partners of childbearing potential",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Must voluntarily sign the Informed Consent Form (ICF), and be able to follow all study requirements and procedures. For the subjects enrolled in Cohort C who are ≥ 12 and < 18 years old, in addition to obtaining the child's own consent, their guardians should provide informed consent and sign the ICF.",
            "criterions": [
                {
                    "exact_snippets": "Must voluntarily sign the Informed Consent Form (ICF)",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "voluntariness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "be able to follow all study requirements and procedures",
                    "criterion": "ability to follow study requirements and procedures",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "subjects enrolled in Cohort C who are ≥ 12 and < 18 years old",
                    "criterion": "age for Cohort C",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 12,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<",
                                        "value": 18,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "their guardians should provide informed consent and sign the ICF",
                    "criterion": "guardian informed consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "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 12 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 12 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Previous exposure to any CD47 antibody, SIRPα antibody, CD47/SIRPα recombinant protein or other inhibitors that act in the same pathway.",
            "criterions": [
                {
                    "exact_snippets": "Previous exposure to any CD47 antibody",
                    "criterion": "CD47 antibody exposure",
                    "requirements": [
                        {
                            "requirement_type": "exposure",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Previous exposure to any ... SIRPα antibody",
                    "criterion": "SIRPα antibody exposure",
                    "requirements": [
                        {
                            "requirement_type": "exposure",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Previous exposure to any ... CD47/SIRPα recombinant protein",
                    "criterion": "CD47/SIRPα recombinant protein exposure",
                    "requirements": [
                        {
                            "requirement_type": "exposure",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Previous exposure to any ... other inhibitors that act in the same pathway",
                    "criterion": "inhibitors in CD47/SIRPα pathway exposure",
                    "requirements": [
                        {
                            "requirement_type": "exposure",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Previous exposure to any anti-programmed death receptor 1 (PD-1) or anti-programmed death-ligand (PD-L1) antibody (except Cohort C).",
            "criterions": [
                {
                    "exact_snippets": "Previous exposure to any anti-programmed death receptor 1 (PD-1) or anti-programmed death-ligand (PD-L1) antibody",
                    "criterion": "previous exposure to PD-1 or PD-L1 antibody",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Concurrent participation in another clinical study.",
            "criterions": [
                {
                    "exact_snippets": "Concurrent participation in another clinical study",
                    "criterion": "participation in another clinical study",
                    "requirements": [
                        {
                            "requirement_type": "concurrency",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. The last dose of anti-tumor therapy is within 4 weeks before the first dose of study treatment.",
            "criterions": [
                {
                    "exact_snippets": "The last dose of anti-tumor therapy is within 4 weeks before the first dose of study treatment.",
                    "criterion": "anti-tumor therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last dose",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Have undergone major surgical procedures within 4 weeks prior to the first dose of study treatment or planned to receive major surgery during the study treatment.",
            "criterions": [
                {
                    "exact_snippets": "undergone major surgical procedures within 4 weeks prior to the first dose of study treatment",
                    "criterion": "major surgical procedures",
                    "requirements": [
                        {
                            "requirement_type": "time since procedure",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "planned to receive major surgery during the study treatment",
                    "criterion": "planned major surgery",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "during study treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Presence of toxicities (excluding alopecia and fatigue) induced by previous anti-tumor therapy that has not recovered to Grade 0 or 1 as assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 prior to the first dose of study treatment.",
            "criterions": [
                {
                    "exact_snippets": "Presence of toxicities (excluding alopecia and fatigue) induced by previous anti-tumor therapy that has not recovered to Grade 0 or 1 as assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0",
                    "criterion": "toxicities induced by previous anti-tumor therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "Grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Known hypersensitivity to IBI188 or any ingredient in the study drug product.",
            "criterions": [
                {
                    "exact_snippets": "Known hypersensitivity to IBI188",
                    "criterion": "hypersensitivity to IBI188",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hypersensitivity to ... any ingredient in the study drug product",
                    "criterion": "hypersensitivity to any ingredient in the study drug product",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. History of other primary malignancies.",
            "criterions": [
                {
                    "exact_snippets": "History of other primary malignancies",
                    "criterion": "other primary malignancies",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Female subjects who are pregnant or lactating.",
            "criterions": [
                {
                    "exact_snippets": "Female subjects",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": "female"
                        }
                    ]
                },
                {
                    "exact_snippets": "pregnant",
                    "criterion": "pregnancy status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "lactating",
                    "criterion": "lactation status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Other ineligible conditions considered by the investigator.",
            "criterions": [
                {
                    "exact_snippets": "Other ineligible conditions considered by the investigator.",
                    "criterion": "ineligible conditions",
                    "requirements": [
                        {
                            "requirement_type": "consideration",
                            "expected_value": "by the investigator"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}