{
    "info": {
        "nct_id": "NCT05021120",
        "official_title": "A Phase 1a/1b, Multicenter, Open-Label, Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Pharmacokinetics, and Anti-tumour Activity of AK127 in Combination With AK104 in Subjects With Advanced or Metastatic Solid Tumours",
        "inclusion_criteria": "1. Written and signed informed consent\n2. In Phase 1a, patients with relapsed or refractory advanced solid malignancies\n3. In Phase 1b, patients must have received no more than three prior lines of systemic therapy\n4. Subject must have at least one measurable lesion according to RECIST Version1.1.\n5. Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1.\n6. Available archived or fresh tumor tissue\n7. Adequate organ function.\n8. For dose-expansion cohorts (Phase 1b), subjects must be willing to provide two fresh biopsy samples (pre-treatment and on treatment), where clinically appropriate.\n9. Females of childbearing potential and non-sterilized males who are sexually active must use an effective method of contraception from screening until 120 days after final dose of investigational product.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. History of severe hypersensitivity reactions to other mAbs.\n2. Subjects with a condition requiring systemic treatment with either corticosteroid (> 10 mg daily ) or other immunosuppressive medications within 2 weeks of study drug administration.\n3. Prior use of approved or investigational anti-TIGIT, anti-PVRIG, or anti-CD96 therapy\n4. Receiving any Other anticancer therapy (e.g., chemotherapy, radiotherapy, biologic or hormonal therapy for cancer treatment. etc.) within 4 weeks prior to the first dose of treatment\n5. Any major surgery within 4 weeks prior to the first dose of treatment\n6. Receiving agents with immunomodulatory effect within 2 weeks prior to the first dose of treatment.\n7. Active or prior documented inflammatory bowel disease\n8. History of organ transplant.\n9. History of interstitial lung disease, noninfectious pneumonitis except for those induced by radiation therapies.\n10. Known active hepatitis B or C infections or history of HIV.\n11. Receipt of live attenuated vaccines within 4 weeks prior to the first dose of investigational product.\n12. Patients with severe heart and lung dysfunction.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Written and signed informed consent",
            "criterions": [
                {
                    "exact_snippets": "Written and signed informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "written and signed"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. In Phase 1a, patients with relapsed or refractory advanced solid malignancies",
            "criterions": [
                {
                    "exact_snippets": "relapsed or refractory advanced solid malignancies",
                    "criterion": "solid malignancies",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "relapsed",
                                "refractory"
                            ]
                        },
                        {
                            "requirement_type": "stage",
                            "expected_value": "advanced"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. In Phase 1b, patients must have received no more than three prior lines of systemic therapy",
            "criterions": [
                {
                    "exact_snippets": "patients must have received no more than three prior lines of systemic therapy",
                    "criterion": "prior lines of systemic therapy",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "lines"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Subject must have at least one measurable lesion according to RECIST Version1.1.",
            "criterions": [
                {
                    "exact_snippets": "at least one measurable lesion according to RECIST Version1.1.",
                    "criterion": "measurable lesion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "lesion"
                            }
                        },
                        {
                            "requirement_type": "measurement standard",
                            "expected_value": "RECIST Version1.1"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1.",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1.",
                    "criterion": "ECOG Performance Score",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Available archived or fresh tumor tissue",
            "criterions": [
                {
                    "exact_snippets": "Available archived or fresh tumor tissue",
                    "criterion": "tumor tissue",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "archived",
                                "fresh"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Adequate organ function.",
            "criterions": [
                {
                    "exact_snippets": "Adequate organ function",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. For dose-expansion cohorts (Phase 1b), subjects must be willing to provide two fresh biopsy samples (pre-treatment and on treatment), where clinically appropriate.",
            "criterions": [
                {
                    "exact_snippets": "subjects must be willing to provide two fresh biopsy samples",
                    "criterion": "willingness to provide biopsy samples",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "two fresh biopsy samples (pre-treatment and on treatment)",
                    "criterion": "biopsy samples",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "=",
                                "value": 2,
                                "unit": "samples"
                            }
                        },
                        {
                            "requirement_type": "timing",
                            "expected_value": [
                                "pre-treatment",
                                "on treatment"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "where clinically appropriate",
                    "criterion": "clinical appropriateness",
                    "requirements": [
                        {
                            "requirement_type": "condition",
                            "expected_value": "clinically appropriate"
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Females of childbearing potential and non-sterilized males who are sexually active must use an effective method of contraception from screening until 120 days after final dose of investigational product.",
            "criterions": [
                {
                    "exact_snippets": "Females of childbearing potential",
                    "criterion": "females of childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "non-sterilized males who are sexually active",
                    "criterion": "non-sterilized males who are sexually active",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "must use an effective method of contraception",
                    "criterion": "use of contraception",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "from screening until 120 days after final dose of investigational product",
                    "criterion": "duration of contraception use",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "from screening until 120 days after final dose of investigational product"
                        }
                    ]
                }
            ]
        },
        {
            "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. History of severe hypersensitivity reactions to other mAbs.",
            "criterions": [
                {
                    "exact_snippets": "History of severe hypersensitivity reactions to other mAbs.",
                    "criterion": "hypersensitivity reactions to mAbs",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Subjects with a condition requiring systemic treatment with either corticosteroid (> 10 mg daily ) or other immunosuppressive medications within 2 weeks of study drug administration.",
            "criterions": [
                {
                    "exact_snippets": "condition requiring systemic treatment with either corticosteroid (> 10 mg daily )",
                    "criterion": "systemic corticosteroid treatment",
                    "requirements": [
                        {
                            "requirement_type": "dosage",
                            "expected_value": {
                                "operator": ">",
                                "value": 10,
                                "unit": "mg daily"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "condition requiring systemic treatment with ... other immunosuppressive medications within 2 weeks of study drug administration",
                    "criterion": "systemic immunosuppressive medication treatment",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 2 weeks of study drug administration"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Prior use of approved or investigational anti-TIGIT, anti-PVRIG, or anti-CD96 therapy",
            "criterions": [
                {
                    "exact_snippets": "Prior use of approved or investigational anti-TIGIT",
                    "criterion": "anti-TIGIT therapy",
                    "requirements": [
                        {
                            "requirement_type": "prior use",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior use of approved or investigational ... anti-PVRIG",
                    "criterion": "anti-PVRIG therapy",
                    "requirements": [
                        {
                            "requirement_type": "prior use",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior use of approved or investigational ... anti-CD96 therapy",
                    "criterion": "anti-CD96 therapy",
                    "requirements": [
                        {
                            "requirement_type": "prior use",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Receiving any Other anticancer therapy (e.g., chemotherapy, radiotherapy, biologic or hormonal therapy for cancer treatment. etc.) within 4 weeks prior to the first dose of treatment",
            "criterions": [
                {
                    "exact_snippets": "Receiving any Other anticancer therapy (e.g., chemotherapy, radiotherapy, biologic or hormonal therapy for cancer treatment. etc.)",
                    "criterion": "anticancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "within 4 weeks prior to the first dose of treatment",
                    "criterion": "time since last anticancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Any major surgery within 4 weeks prior to the first dose of treatment",
            "criterions": [
                {
                    "exact_snippets": "Any major surgery within 4 weeks prior to the first dose of treatment",
                    "criterion": "major surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Receiving agents with immunomodulatory effect within 2 weeks prior to the first dose of treatment.",
            "criterions": [
                {
                    "exact_snippets": "Receiving agents with immunomodulatory effect",
                    "criterion": "immunomodulatory agents",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 2 weeks prior to the first dose of treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Active or prior documented inflammatory bowel disease",
            "criterions": [
                {
                    "exact_snippets": "Active or prior documented inflammatory bowel disease",
                    "criterion": "inflammatory bowel disease",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "active",
                                "prior"
                            ]
                        },
                        {
                            "requirement_type": "documentation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. History of organ transplant.",
            "criterions": [
                {
                    "exact_snippets": "History of organ transplant",
                    "criterion": "organ transplant",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. History of interstitial lung disease, noninfectious pneumonitis except for those induced by radiation therapies.",
            "criterions": [
                {
                    "exact_snippets": "History of interstitial lung disease",
                    "criterion": "interstitial lung disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "noninfectious pneumonitis",
                    "criterion": "noninfectious pneumonitis",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "except for those induced by radiation therapies",
                    "criterion": "radiation therapy-induced pneumonitis",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Known active hepatitis B or C infections or history of HIV.",
            "criterions": [
                {
                    "exact_snippets": "Known active hepatitis B",
                    "criterion": "hepatitis B infection",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "active"
                        }
                    ]
                },
                {
                    "exact_snippets": "Known active ... C infections",
                    "criterion": "hepatitis C infection",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "active"
                        }
                    ]
                },
                {
                    "exact_snippets": "history of HIV",
                    "criterion": "HIV",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Receipt of live attenuated vaccines within 4 weeks prior to the first dose of investigational product.",
            "criterions": [
                {
                    "exact_snippets": "Receipt of live attenuated vaccines within 4 weeks prior to the first dose of investigational product.",
                    "criterion": "receipt of live attenuated vaccines",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Patients with severe heart and lung dysfunction.",
            "criterions": [
                {
                    "exact_snippets": "severe heart ... dysfunction",
                    "criterion": "heart dysfunction",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                },
                {
                    "exact_snippets": "severe ... lung dysfunction",
                    "criterion": "lung dysfunction",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}