{
    "info": {
        "nct_id": "NCT05007782",
        "official_title": "A Phase 1 Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of GS-1811, an Afucosylated Anti-CCR8 Monoclonal Antibody, as Monotherapy and in Combination With an Anti-PD-1 Monoclonal Antibody in Adults With Advanced Solid Tumors",
        "inclusion_criteria": "* Disease:\n\n  * Part A: Individuals with histologically or cytologically confirmed advanced solid tumors who have received, been intolerant to, or been ineligible for all treatment known to confer clinical benefit.\n  * Part B: Individuals with histologically or cytologically confirmed select indications who have received, been intolerant to, or been ineligible for all treatment known to confer clinical benefit.\n  * Part C: Individuals with histologically or cytologically confirmed advanced solid tumors who have received, been intolerant to, or been ineligible for all treatments known to confer clinical benefit or whose disease is indicated for anti- programmed cell death protein 1 or programmed cell death ligand 1 (PD-[L]1) monoclonal antibody monotherapy.\n  * Part D: Individuals with pathologically confirmed select advanced solid tumors.\n  * Part E: Individuals with pathologically confirmed select advanced solid tumors. Participants must have received, have been intolerant to, or have been ineligible for all treatment known to confer clinical benefit.\n  * Part F: Individuals with pathologically-confirmed select advanced solid tumors. Participants must have received, have been intolerant to, or have been ineligible for all treatments known to confer clinical benefit; or, for participants who will undergo combination therapy, have disease which is indicated for anti-PD-(L)1 mAb monotherapy.\n* Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1\n* Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 for individuals in Parts A, B, and C, and 0 or 1 for individuals in Parts D, E, and F.\n* Adequate organ function.\n* Male individuals and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use methods of contraception.\n* Tissue requirement:\n\n  * Parts A, C, D, E and F: Must provide pre-treatment adequate tumor tissue sample prior to enrollment.\n  * Part B and select participants in Parts C and F: Must have fresh pre-treatment and on-treatment biopsies for biomarker analysis.\n\nKey\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Concurrent anticancer treatment.\n* Any anti-cancer therapy, whether investigational or approved, within protocol specified time prior to initiation of study including: immunotherapy or biologic therapy (< 28 days), chemotherapy (< 21 days), targeted small molecule therapy (< 14 days), hormonal therapy or other adjunctive therapy (< 14 days) or radiotherapy (< 21 days).\n* Any prior CCR8 directed therapy.\n* Prior allogeneic tissue/solid organ transplantation, including allogeneic stem cell transplantation. Exception: prior corneal transplant without requirement for systemic immunosuppressive agents is allowed.\n* Concurrent active malignancy other than nonmelanoma skin cancer, curatively resected carcinoma in situ, localized prostate cancer, or superficial bladder cancer after undergoing potentially curative therapy with no evidence of disease. Individuals with other previous malignancies are eligible if disease-free for > 2 years.\n* History of intolerance, hypersensitivity, or treatment discontinuation due to severe immune-related adverse events (irAEs) on prior immunotherapy.\n* History of autoimmune disease or active autoimmune disease requiring systemic treatment within 2 years.\n* History of pneumonitis, interstitial lung disease, or severe radiation pneumonitis (excluding localized radiation pneumonitis).\n* Active and clinically relevant bacterial, fungal, or viral infection that is not controlled or requires IV antibiotics.\n* Active hepatitis B virus (HBV) and/or hepatitis C virus (HCV), and/or human immunodeficiency virus (HIV).\n* Positive serum pregnancy test or breastfeeding female.\n* Live vaccines within 30 days prior to first dose.\n* Significant cardiovascular disease.\n\nNote: Other protocol defined Inclusion/Exclusion criteria may apply.",
        "miscellaneous_criteria": "Key"
    },
    "inclusion_lines": [
        {
            "line": "* Disease:",
            "criterions": [
                {
                    "exact_snippets": "Disease:",
                    "criterion": "disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Part A: Individuals with histologically or cytologically confirmed advanced solid tumors who have received, been intolerant to, or been ineligible for all treatment known to confer clinical benefit.",
            "criterions": [
                {
                    "exact_snippets": "histologically or cytologically confirmed advanced solid tumors",
                    "criterion": "advanced solid tumors",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "received, been intolerant to, or been ineligible for all treatment known to confer clinical benefit",
                    "criterion": "treatment history",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "received",
                                "intolerant",
                                "ineligible"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Part B: Individuals with histologically or cytologically confirmed select indications who have received, been intolerant to, or been ineligible for all treatment known to confer clinical benefit.",
            "criterions": [
                {
                    "exact_snippets": "histologically or cytologically confirmed select indications",
                    "criterion": "select indications",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "received, been intolerant to, or been ineligible for all treatment known to confer clinical benefit",
                    "criterion": "treatment history",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "received",
                                "intolerant",
                                "ineligible"
                            ]
                        },
                        {
                            "requirement_type": "treatment type",
                            "expected_value": "all treatment known to confer clinical benefit"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Part C: Individuals with histologically or cytologically confirmed advanced solid tumors who have received, been intolerant to, or been ineligible for all treatments known to confer clinical benefit or whose disease is indicated for anti- programmed cell death protein 1 or programmed cell death ligand 1 (PD-[L]1) monoclonal antibody monotherapy.",
            "criterions": [
                {
                    "exact_snippets": "histologically or cytologically confirmed advanced solid tumors",
                    "criterion": "advanced solid tumors",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "received, been intolerant to, or been ineligible for all treatments known to confer clinical benefit",
                    "criterion": "treatment history",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "received",
                                "intolerant",
                                "ineligible"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "disease is indicated for anti- programmed cell death protein 1 or programmed cell death ligand 1 (PD-[L]1) monoclonal antibody monotherapy",
                    "criterion": "indication for PD-[L]1 monoclonal antibody monotherapy",
                    "requirements": [
                        {
                            "requirement_type": "indication",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Part D: Individuals with pathologically confirmed select advanced solid tumors.",
            "criterions": [
                {
                    "exact_snippets": "pathologically confirmed",
                    "criterion": "pathological confirmation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "select advanced solid tumors",
                    "criterion": "advanced solid tumors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Part E: Individuals with pathologically confirmed select advanced solid tumors. Participants must have received, have been intolerant to, or have been ineligible for all treatment known to confer clinical benefit.",
            "criterions": [
                {
                    "exact_snippets": "pathologically confirmed select advanced solid tumors",
                    "criterion": "advanced solid tumors",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "pathologically confirmed"
                        },
                        {
                            "requirement_type": "selection",
                            "expected_value": "select"
                        }
                    ]
                },
                {
                    "exact_snippets": "Participants must have received, have been intolerant to, or have been ineligible for all treatment known to confer clinical benefit",
                    "criterion": "treatment history",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "received",
                                "intolerant",
                                "ineligible"
                            ]
                        },
                        {
                            "requirement_type": "treatment type",
                            "expected_value": "all treatment known to confer clinical benefit"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Part F: Individuals with pathologically-confirmed select advanced solid tumors. Participants must have received, have been intolerant to, or have been ineligible for all treatments known to confer clinical benefit; or, for participants who will undergo combination therapy, have disease which is indicated for anti-PD-(L)1 mAb monotherapy.",
            "criterions": [
                {
                    "exact_snippets": "pathologically-confirmed select advanced solid tumors",
                    "criterion": "advanced solid tumors",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "pathologically-confirmed"
                        },
                        {
                            "requirement_type": "selection",
                            "expected_value": "select"
                        }
                    ]
                },
                {
                    "exact_snippets": "Participants must have received, have been intolerant to, or have been ineligible for all treatments known to confer clinical benefit",
                    "criterion": "treatment history",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "received",
                                "intolerant",
                                "ineligible"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "participants who will undergo combination therapy, have disease which is indicated for anti-PD-(L)1 mAb monotherapy",
                    "criterion": "disease indication",
                    "requirements": [
                        {
                            "requirement_type": "indication",
                            "expected_value": "anti-PD-(L)1 mAb monotherapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1",
            "criterions": [
                {
                    "exact_snippets": "Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1",
                    "criterion": "measurable disease",
                    "requirements": [
                        {
                            "requirement_type": "evaluation criteria",
                            "expected_value": "Response Evaluation Criteria in Solid Tumors (RECIST) v1.1"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate organ function.",
            "criterions": [
                {
                    "exact_snippets": "Adequate organ function.",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": "adequate"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Male individuals and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use methods of contraception.",
            "criterions": [
                {
                    "exact_snippets": "Male individuals",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "male"
                        }
                    ]
                },
                {
                    "exact_snippets": "female individuals of childbearing potential",
                    "criterion": "gender and reproductive status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "female"
                        },
                        {
                            "requirement_type": "reproductive status",
                            "expected_value": "childbearing potential"
                        }
                    ]
                },
                {
                    "exact_snippets": "engage in heterosexual intercourse",
                    "criterion": "sexual activity",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "heterosexual intercourse"
                        }
                    ]
                },
                {
                    "exact_snippets": "must agree to use methods of contraception",
                    "criterion": "contraception agreement",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Tissue requirement:",
            "criterions": [
                {
                    "exact_snippets": "Tissue requirement",
                    "criterion": "tissue",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Parts A, C, D, E and F: Must provide pre-treatment adequate tumor tissue sample prior to enrollment.",
            "criterions": [
                {
                    "exact_snippets": "pre-treatment adequate tumor tissue sample",
                    "criterion": "tumor tissue sample",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "timing",
                            "expected_value": "pre-treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Part B and select participants in Parts C and F: Must have fresh pre-treatment and on-treatment biopsies for biomarker analysis.",
            "criterions": [
                {
                    "exact_snippets": "Must have fresh pre-treatment and on-treatment biopsies",
                    "criterion": "biopsies",
                    "requirements": [
                        {
                            "requirement_type": "freshness",
                            "expected_value": "fresh"
                        },
                        {
                            "requirement_type": "timing",
                            "expected_value": [
                                "pre-treatment",
                                "on-treatment"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "biopsies for biomarker analysis",
                    "criterion": "biomarker analysis",
                    "requirements": [
                        {
                            "requirement_type": "purpose",
                            "expected_value": "biomarker analysis"
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Concurrent anticancer treatment.",
            "criterions": [
                {
                    "exact_snippets": "Concurrent anticancer treatment.",
                    "criterion": "anticancer treatment",
                    "requirements": [
                        {
                            "requirement_type": "concurrency",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any anti-cancer therapy, whether investigational or approved, within protocol specified time prior to initiation of study including: immunotherapy or biologic therapy (< 28 days), chemotherapy (< 21 days), targeted small molecule therapy (< 14 days), hormonal therapy or other adjunctive therapy (< 14 days) or radiotherapy (< 21 days).",
            "criterions": [
                {
                    "exact_snippets": "Any anti-cancer therapy, whether investigational or approved, within protocol specified time prior to initiation of study",
                    "criterion": "anti-cancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "immunotherapy or biologic therapy (< 28 days)",
                    "criterion": "immunotherapy or biologic therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "chemotherapy (< 21 days)",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<",
                                "value": 21,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "targeted small molecule therapy (< 14 days)",
                    "criterion": "targeted small molecule therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "hormonal therapy or other adjunctive therapy (< 14 days)",
                    "criterion": "hormonal therapy or other adjunctive therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "radiotherapy (< 21 days)",
                    "criterion": "radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<",
                                "value": 21,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any prior CCR8 directed therapy.",
            "criterions": [
                {
                    "exact_snippets": "Any prior CCR8 directed therapy.",
                    "criterion": "CCR8 directed therapy",
                    "requirements": [
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior allogeneic tissue/solid organ transplantation, including allogeneic stem cell transplantation. Exception: prior corneal transplant without requirement for systemic immunosuppressive agents is allowed.",
            "criterions": [
                {
                    "exact_snippets": "Prior allogeneic tissue/solid organ transplantation, including allogeneic stem cell transplantation.",
                    "criterion": "prior allogeneic transplantation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Exception: prior corneal transplant without requirement for systemic immunosuppressive agents is allowed.",
                    "criterion": "prior corneal transplant",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "systemic immunosuppressive agents",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Concurrent active malignancy other than nonmelanoma skin cancer, curatively resected carcinoma in situ, localized prostate cancer, or superficial bladder cancer after undergoing potentially curative therapy with no evidence of disease. Individuals with other previous malignancies are eligible if disease-free for > 2 years.",
            "criterions": [
                {
                    "exact_snippets": "Concurrent active malignancy other than nonmelanoma skin cancer, curatively resected carcinoma in situ, localized prostate cancer, or superficial bladder cancer",
                    "criterion": "concurrent active malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Individuals with other previous malignancies are eligible if disease-free for > 2 years",
                    "criterion": "previous malignancies",
                    "requirements": [
                        {
                            "requirement_type": "disease-free duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of intolerance, hypersensitivity, or treatment discontinuation due to severe immune-related adverse events (irAEs) on prior immunotherapy.",
            "criterions": [
                {
                    "exact_snippets": "History of intolerance, hypersensitivity, or treatment discontinuation due to severe immune-related adverse events (irAEs) on prior immunotherapy.",
                    "criterion": "intolerance to prior immunotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of intolerance, hypersensitivity, or treatment discontinuation due to severe immune-related adverse events (irAEs) on prior immunotherapy.",
                    "criterion": "hypersensitivity to prior immunotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of intolerance, hypersensitivity, or treatment discontinuation due to severe immune-related adverse events (irAEs) on prior immunotherapy.",
                    "criterion": "treatment discontinuation due to severe immune-related adverse events (irAEs) on prior immunotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of autoimmune disease or active autoimmune disease requiring systemic treatment within 2 years.",
            "criterions": [
                {
                    "exact_snippets": "History of autoimmune disease",
                    "criterion": "autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "active autoimmune disease requiring systemic treatment within 2 years",
                    "criterion": "autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "treatment",
                            "expected_value": "systemic"
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 2 years"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of pneumonitis, interstitial lung disease, or severe radiation pneumonitis (excluding localized radiation pneumonitis).",
            "criterions": [
                {
                    "exact_snippets": "History of pneumonitis",
                    "criterion": "pneumonitis",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of ... interstitial lung disease",
                    "criterion": "interstitial lung disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of ... severe radiation pneumonitis",
                    "criterion": "severe radiation pneumonitis",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "excluding localized radiation pneumonitis",
                    "criterion": "localized radiation pneumonitis",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active and clinically relevant bacterial, fungal, or viral infection that is not controlled or requires IV antibiotics.",
            "criterions": [
                {
                    "exact_snippets": "Active and clinically relevant bacterial, fungal, or viral infection",
                    "criterion": "bacterial, fungal, or viral infection",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        },
                        {
                            "requirement_type": "clinical relevance",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "infection that is not controlled",
                    "criterion": "infection control",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "infection ... requires IV antibiotics",
                    "criterion": "IV antibiotics requirement",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active hepatitis B virus (HBV) and/or hepatitis C virus (HCV), and/or human immunodeficiency virus (HIV).",
            "criterions": [
                {
                    "exact_snippets": "Active hepatitis B virus (HBV)",
                    "criterion": "hepatitis B virus (HBV)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hepatitis C virus (HCV)",
                    "criterion": "hepatitis C virus (HCV)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "human immunodeficiency virus (HIV)",
                    "criterion": "human immunodeficiency virus (HIV)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Positive serum pregnancy test or breastfeeding female.",
            "criterions": [
                {
                    "exact_snippets": "Positive serum pregnancy test",
                    "criterion": "serum pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "breastfeeding female",
                    "criterion": "breastfeeding status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "breastfeeding"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Live vaccines within 30 days prior to first dose.",
            "criterions": [
                {
                    "exact_snippets": "Live vaccines within 30 days prior to first dose.",
                    "criterion": "live vaccines",
                    "requirements": [
                        {
                            "requirement_type": "administration timing",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 30,
                                        "unit": "days"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Significant cardiovascular disease.",
            "criterions": [
                {
                    "exact_snippets": "Significant cardiovascular disease",
                    "criterion": "cardiovascular disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Note: Other protocol defined Inclusion/Exclusion criteria may apply.",
            "criterions": [
                {
                    "exact_snippets": "Other protocol defined Inclusion/Exclusion criteria",
                    "criterion": "protocol defined Inclusion/Exclusion criteria",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "* Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 for individuals in Parts A, B, and C, and 0 or 1 for individuals in Parts D, E, and F.",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 for individuals in Parts A, B, and C",
                    "criterion": "ECOG performance status for Parts A, B, and C",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "0",
                                "1",
                                "2"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "ECOG performance status ... 0 or 1 for individuals in Parts D, E, and F",
                    "criterion": "ECOG performance status for Parts D, E, and F",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "Key",
            "criterions": [
                {
                    "exact_snippets": "Tissue from tumor must be available",
                    "criterion": "tumor tissue",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Tissue from tumor ... > 2 cm in diameter.",
                    "criterion": "tumor tissue",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "cm"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "Key",
            "criterions": [
                {
                    "exact_snippets": "Tissue from tumor must be available",
                    "criterion": "tumor tissue",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Tissue from tumor ... > 2 cm in diameter.",
                    "criterion": "tumor tissue",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "cm"
                            }
                        }
                    ]
                }
            ]
        }
    ]
}