{
    "info": {
        "nct_id": "NCT06402201",
        "official_title": "Phase 1, First-in-Human Study to Assess the Safety, Tolerability and Anti-tumor Activity of CDR404 in HLA-A*02:01 Participants with MAGE-A4 Expressing Solid Tumors",
        "inclusion_criteria": "1. Provision of written informed consent\n2. HLA-A*02:01 positive\n3. MAGE-A4 positive tumor\n4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) [ECOG PS] 0 or 1\n5. Selected advanced solid tumors\n6. Relapsed from, refractory to, or intolerant of standard therapy\n7. Measurable disease per RECIST v1.1\n8. Adequate organ function\n9. If applicable, must agree to use highly effective contraception\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Symptomatic or untreated central nervous system metastasis\n2. Inadequate washout from prior anticancer therapy\n3. Significant ongoing toxicity from prior anticancer treatment\n4. Recent surgery\n5. Clinically significant cardiac disease\n6. Active infection requiring systemic antibiotic treatment\n7. Human immunodeficiency virus (HIV) at risk of acquired immunodeficiency syndrome (AIDS)-related outcomes\n8. Active hepatitis B virus (HBV) or hepatitis C virus (HBC)\n9. Ongoing treatment with systemic steroids or other immunosuppressive therapies\n10. Significant secondary malignancy\n11. History of chronic or recurrent active autoimmune disease requiring treatment\n12. Uncontrolled intercurrent illness\n13. Pregnancy or lactation.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Provision of written informed consent",
            "criterions": [
                {
                    "exact_snippets": "Provision of written informed consent",
                    "criterion": "written informed consent",
                    "requirements": [
                        {
                            "requirement_type": "provision",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. HLA-A*02:01 positive",
            "criterions": [
                {
                    "exact_snippets": "HLA-A*02:01 positive",
                    "criterion": "HLA-A*02:01",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. MAGE-A4 positive tumor",
            "criterions": [
                {
                    "exact_snippets": "MAGE-A4 positive tumor",
                    "criterion": "MAGE-A4",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) [ECOG PS] 0 or 1",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status (PS) [ECOG PS] 0 or 1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Selected advanced solid tumors",
            "criterions": [
                {
                    "exact_snippets": "advanced solid tumors",
                    "criterion": "solid tumors",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "advanced"
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Relapsed from, refractory to, or intolerant of standard therapy",
            "criterions": [
                {
                    "exact_snippets": "Relapsed from ... standard therapy",
                    "criterion": "relapse from standard therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "refractory to ... standard therapy",
                    "criterion": "refractory to standard therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "intolerant of standard therapy",
                    "criterion": "intolerance to standard therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Measurable disease per RECIST v1.1",
            "criterions": [
                {
                    "exact_snippets": "Measurable disease per RECIST v1.1",
                    "criterion": "measurable disease",
                    "requirements": [
                        {
                            "requirement_type": "standard",
                            "expected_value": "RECIST v1.1"
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Adequate organ function",
            "criterions": [
                {
                    "exact_snippets": "Adequate organ function",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. If applicable, must agree to use highly effective contraception",
            "criterions": [
                {
                    "exact_snippets": "must agree to use highly effective contraception",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "effectiveness",
                            "expected_value": "highly effective"
                        }
                    ]
                }
            ]
        },
        {
            "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. Symptomatic or untreated central nervous system metastasis",
            "criterions": [
                {
                    "exact_snippets": "Symptomatic ... central nervous system metastasis",
                    "criterion": "central nervous system metastasis",
                    "requirements": [
                        {
                            "requirement_type": "symptomatic",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "untreated central nervous system metastasis",
                    "criterion": "central nervous system metastasis",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "untreated"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Inadequate washout from prior anticancer therapy",
            "criterions": [
                {
                    "exact_snippets": "Inadequate washout from prior anticancer therapy",
                    "criterion": "washout period from prior anticancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Significant ongoing toxicity from prior anticancer treatment",
            "criterions": [
                {
                    "exact_snippets": "Significant ongoing toxicity from prior anticancer treatment",
                    "criterion": "toxicity from prior anticancer treatment",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        },
                        {
                            "requirement_type": "status",
                            "expected_value": "ongoing"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Recent surgery",
            "criterions": [
                {
                    "exact_snippets": "Recent surgery",
                    "criterion": "surgery",
                    "requirements": [
                        {
                            "requirement_type": "recency",
                            "expected_value": "recent"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Clinically significant cardiac disease",
            "criterions": [
                {
                    "exact_snippets": "Clinically significant cardiac disease",
                    "criterion": "cardiac disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "clinically significant"
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Active infection requiring systemic antibiotic treatment",
            "criterions": [
                {
                    "exact_snippets": "Active infection requiring systemic antibiotic treatment",
                    "criterion": "active infection",
                    "requirements": [
                        {
                            "requirement_type": "treatment necessity",
                            "expected_value": "systemic antibiotic treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Human immunodeficiency virus (HIV) at risk of acquired immunodeficiency syndrome (AIDS)-related outcomes",
            "criterions": [
                {
                    "exact_snippets": "Human immunodeficiency virus (HIV)",
                    "criterion": "HIV status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "at risk of acquired immunodeficiency syndrome (AIDS)-related outcomes",
                    "criterion": "risk of AIDS-related outcomes",
                    "requirements": [
                        {
                            "requirement_type": "risk",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Active hepatitis B virus (HBV) or hepatitis C virus (HBC)",
            "criterions": [
                {
                    "exact_snippets": "Active hepatitis B virus (HBV)",
                    "criterion": "hepatitis B virus (HBV)",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    ]
                },
                {
                    "exact_snippets": "Active ... hepatitis C virus (HBC)",
                    "criterion": "hepatitis C virus (HBC)",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Ongoing treatment with systemic steroids or other immunosuppressive therapies",
            "criterions": [
                {
                    "exact_snippets": "Ongoing treatment with systemic steroids",
                    "criterion": "systemic steroid treatment",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "ongoing"
                        }
                    ]
                },
                {
                    "exact_snippets": "Ongoing treatment with ... other immunosuppressive therapies",
                    "criterion": "immunosuppressive therapy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "ongoing"
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Significant secondary malignancy",
            "criterions": [
                {
                    "exact_snippets": "Significant secondary malignancy",
                    "criterion": "secondary malignancy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. History of chronic or recurrent active autoimmune disease requiring treatment",
            "criterions": [
                {
                    "exact_snippets": "History of chronic or recurrent active autoimmune disease",
                    "criterion": "autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "chronicity",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "recurrence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "activity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "requiring treatment",
                    "criterion": "autoimmune disease treatment",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Uncontrolled intercurrent illness",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled intercurrent illness",
                    "criterion": "intercurrent illness",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. Pregnancy or lactation.",
            "criterions": [
                {
                    "exact_snippets": "Pregnancy",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "lactation",
                    "criterion": "lactation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}