{
    "info": {
        "nct_id": "NCT03650348",
        "official_title": "A Phase 1b, Open-Label, Dose Escalation Study of PRS-343 in Combination With Atezolizumab in Patients With HER2-Positive Advanced or Metastatic Solid Tumors",
        "inclusion_criteria": "1. Signed written informed consent obtained prior to performing any study procedure, including screening procedures.\n2. Men and women ≥18 years.\n3. Histologically or cytologically confirmed diagnosis of previously treated locally advanced and/or metastatic HER2+ solid tumor malignancy considered likely to respond to a HER2-targeted CD137 agonist (e.g. gastric/gastroesophageal/esophageal, breast, bladder).\n4. HER2+ status documented by clinical pathology report.\n5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2.\n6. Estimated life expectancy of at least 3 months.\n7. Measurable disease according to RECIST v1.1.\n8. Adequate organ function as defined below:\n9. Serum AST and ALT ≤ 2.5 X ULN or ≤ 5 X ULN in the presence of liver metastases.\n10. Total serum bilirubin ≤ 1.5 X ULN.\n11. Serum creatinine ≤ 2 X ULN OR calculated glomerular filtration rate (GFR) by Cockcroft-Gault formula ≥ 30 mL/min.\n12. Hemoglobin ≥ 9 g/dL.\n13. ANC ≥ 1500/mm3.\n14. Platelet count ≥ 75,000/mm3.\n15. Left ventricular ejection fraction (LVEF) determined by echocardiogram or multi-gated acquisition scan ≥ 50%.\n16. Any prior cumulative doxorubicin dose must be ≤ 360 mg/m2; prior cumulative epirubicin dose must be ≤ 720 mg/m2.\n17. Women of childbearing potential must have a negative serum or urine pregnancy test within 96 hours prior to start of study treatment.\n18. Women must not be breastfeeding.\n19. Women of childbearing potential must agree to follow instruction for method(s) of contraception for the duration of treatment with study drug PRS 343 and atezolizumab plus 5 months post-treatment completion.\n20. Males who are sexually active with women of childbearing potential must agree to follow instructions for method(s) of contraception for the duration of treatment with study treatment plus 90 days post-treatment completion.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Known uncontrolled central nervous system (CNS) metastases and/or carcinomatous meningitis. Note: Patients with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least 4 weeks prior to the first dose of study treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are clinically stable off steroids for at least 7 days prior to study treatment. Carcinomatous meningitis precludes a patient from study participation regardless of clinical stability.\n2. History of acute coronary syndromes, including myocardial infarction, coronary artery bypass graft, unstable angina, coronary angioplasty or stenting within past 24 weeks.\n3. History of or current Class II, III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system (Appendix B).\n4. History of ejection fraction drop below the lower limit of normal with trastuzumab and/or pertuzumab.\n5. Medical, psychiatric, cognitive or other conditions that compromise the patient's ability to understand the patient information, to give informed consent, to comply with the study protocol or to complete the study.\n6. Any severe concurrent disease or condition (includes active infections, cardiac arrhythmia, interstitial lung disease) that in the judgment of the Investigator would make study participation inappropriate for the patient.\n7. Previously known infection with human immunodeficiency virus (HIV); or hepatitis B virus (HBV) or hepatitis C virus (HCV) (unless patients are HBV DNA / HCV RNA negative).\n8. Any severe infection within 28 days prior to Cycle 1 Day 1, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia or active tuberculosis.\n9. Administration of live, attenuated vaccines within 28 days before Cycle 1 Day 1 or anticipated need of vaccination with live attenuated vaccine during the study.\n10. Need for the treatment of bacterial infection with oral or intravenous (IV) antibiotics within 14 days prior to Cycle 1 Day 1.\n11. History of infusion reactions to any component/excipient of PRS-343.\n12. History of infusion reactions to any component/excipient of atezolizumab.\n13. History of severe hypersensitivity reactions to monoclonal antibodies (mAbs).\n14. Systemic steroid therapy (>10 mg daily prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment (note: topical, inhaled, nasal and ophthalmic steroids are not prohibited).\n15. Autoimmune disease that has required systemic treatment in the past (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is allowed.\n16. Prior organ transplantation including allogeneic or autologous stem-cell transplantation.\n17. Has not recovered from the adverse effect of previous anticancer treatments to pre-treatment baseline or Grade 1 except for alopecia, anemia (hemoglobin must meet the study inclusion criteria) and peripheral neuropathy (which must have recovered to ≤ Grade 2) nausea and diarrhea if anti-emetic and anti-diarrheal treatment hasn't been exhausted.\n18. Concurrent or previous other malignancy within 5 years of study entry with the exception of cured basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in-situ of the cervix, or other noninvasive or indolent malignancy.\n19. Receipt of investigational treatment within 3 weeks of scheduled Cycle 1 Day 1 (C1D1) dosing.\n20. Receipt of cytotoxic chemotherapy within 3 weeks (6 weeks for nitrosoureas and mitomycin C) of scheduled C1D1 dosing.\n21. Receipt of radiation therapy within 3 weeks of scheduled Day 1 dosing, unless the radiation comprised a limited field to non-visceral structures (e.g., limb bone metastasis).\n22. Receipt of treatment with immunotherapy, biological therapies, hormonal therapies within 3 weeks of scheduled C1D1 dosing.\n23. Treatment with targeted small molecules within 5 half-lives of scheduled C1D1 dosing.\n24. Receipt of trastuzumab or ado-trastuzumab emtansine or any other experimental drug that engages the same epitope as trastuzumab within 4 weeks of scheduled C1D1 dosing.\n25. Receipt of atezolizumab or any other experimental drug that engages the same epitope as atezolizumab within 4 weeks of scheduled C1D1 dosing.\n26. Concurrent enrollment in another therapeutic clinical trial.\n27. Major surgery within 3 weeks of scheduled C1D1 dosing.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Signed written informed consent obtained prior to performing any study procedure, including screening procedures.",
            "criterions": [
                {
                    "exact_snippets": "Signed written informed consent obtained",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Men and women ≥18 years.",
            "criterions": [
                {
                    "exact_snippets": "Men and women",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "inclusion",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "≥18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Histologically or cytologically confirmed diagnosis of previously treated locally advanced and/or metastatic HER2+ solid tumor malignancy considered likely to respond to a HER2-targeted CD137 agonist (e.g. gastric/gastroesophageal/esophageal, breast, bladder).",
            "criterions": [
                {
                    "exact_snippets": "Histologically or cytologically confirmed diagnosis",
                    "criterion": "diagnosis confirmation method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "previously treated",
                    "criterion": "treatment history",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "previously treated"
                        }
                    ]
                },
                {
                    "exact_snippets": "locally advanced and/or metastatic",
                    "criterion": "tumor stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "locally advanced",
                                "metastatic"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "HER2+ solid tumor malignancy",
                    "criterion": "HER2 status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "HER2+"
                        }
                    ]
                },
                {
                    "exact_snippets": "considered likely to respond to a HER2-targeted CD137 agonist",
                    "criterion": "response likelihood to HER2-targeted CD137 agonist",
                    "requirements": [
                        {
                            "requirement_type": "likelihood",
                            "expected_value": "likely to respond"
                        }
                    ]
                },
                {
                    "exact_snippets": "(e.g. gastric/gastroesophageal/esophageal, breast, bladder)",
                    "criterion": "tumor type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "gastric",
                                "gastroesophageal",
                                "esophageal",
                                "breast",
                                "bladder"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. HER2+ status documented by clinical pathology report.",
            "criterions": [
                {
                    "exact_snippets": "HER2+ status documented by clinical pathology report",
                    "criterion": "HER2+ status",
                    "requirements": [
                        {
                            "requirement_type": "documentation",
                            "expected_value": "clinical pathology report"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2.",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Estimated life expectancy of at least 3 months.",
            "criterions": [
                {
                    "exact_snippets": "Estimated life expectancy of at least 3 months.",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Measurable disease according to RECIST v1.1.",
            "criterions": [
                {
                    "exact_snippets": "Measurable disease according to RECIST v1.1.",
                    "criterion": "measurable disease",
                    "requirements": [
                        {
                            "requirement_type": "criteria",
                            "expected_value": "RECIST v1.1"
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Adequate organ function as defined below:",
            "criterions": [
                {
                    "exact_snippets": "Adequate organ function",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Total serum bilirubin ≤ 1.5 X ULN.",
            "criterions": [
                {
                    "exact_snippets": "Total serum bilirubin ≤ 1.5 X ULN.",
                    "criterion": "total serum bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "X ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Serum creatinine ≤ 2 X ULN OR calculated glomerular filtration rate (GFR) by Cockcroft-Gault formula ≥ 30 mL/min.",
            "criterions": [
                {
                    "exact_snippets": "Serum creatinine ≤ 2 X ULN",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "X ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "calculated glomerular filtration rate (GFR) by Cockcroft-Gault formula ≥ 30 mL/min",
                    "criterion": "glomerular filtration rate (GFR)",
                    "requirements": [
                        {
                            "requirement_type": "calculation method",
                            "expected_value": "Cockcroft-Gault formula"
                        },
                        {
                            "requirement_type": "rate",
                            "expected_value": {
                                "operator": ">=",
                                "value": 30,
                                "unit": "mL/min"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Hemoglobin ≥ 9 g/dL.",
            "criterions": [
                {
                    "exact_snippets": "Hemoglobin ≥ 9 g/dL",
                    "criterion": "hemoglobin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 9,
                                "unit": "g/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. ANC ≥ 1500/mm3.",
            "criterions": [
                {
                    "exact_snippets": "ANC ≥ 1500/mm3",
                    "criterion": "ANC",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "mm3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "14. Platelet count ≥ 75,000/mm3.",
            "criterions": [
                {
                    "exact_snippets": "Platelet count ≥ 75,000/mm3.",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 75000,
                                "unit": "mm3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "15. Left ventricular ejection fraction (LVEF) determined by echocardiogram or multi-gated acquisition scan ≥ 50%.",
            "criterions": [
                {
                    "exact_snippets": "Left ventricular ejection fraction (LVEF) ... ≥ 50%",
                    "criterion": "left ventricular ejection fraction (LVEF)",
                    "requirements": [
                        {
                            "requirement_type": "measurement",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "16. Any prior cumulative doxorubicin dose must be ≤ 360 mg/m2; prior cumulative epirubicin dose must be ≤ 720 mg/m2.",
            "criterions": [
                {
                    "exact_snippets": "prior cumulative doxorubicin dose must be ≤ 360 mg/m2",
                    "criterion": "cumulative doxorubicin dose",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 360,
                                "unit": "mg/m2"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "prior cumulative epirubicin dose must be ≤ 720 mg/m2",
                    "criterion": "cumulative epirubicin dose",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 720,
                                "unit": "mg/m2"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "17. Women of childbearing potential must have a negative serum or urine pregnancy test within 96 hours prior to start of study treatment.",
            "criterions": [
                {
                    "exact_snippets": "Women of childbearing potential",
                    "criterion": "women of childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "negative serum or urine pregnancy test",
                    "criterion": "pregnancy test result",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "within 96 hours prior to start of study treatment",
                    "criterion": "timing of pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 96 hours prior to start of study treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "18. Women must not be breastfeeding.",
            "criterions": [
                {
                    "exact_snippets": "Women must not be breastfeeding.",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "19. Women of childbearing potential must agree to follow instruction for method(s) of contraception for the duration of treatment with study drug PRS 343 and atezolizumab plus 5 months post-treatment completion.",
            "criterions": [
                {
                    "exact_snippets": "Women of childbearing potential",
                    "criterion": "women of childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "must agree to follow instruction for method(s) of contraception",
                    "criterion": "contraception agreement",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "for the duration of treatment with study drug PRS 343 and atezolizumab plus 5 months post-treatment completion",
                    "criterion": "contraception duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "duration of treatment with study drug PRS 343 and atezolizumab plus 5 months post-treatment completion"
                        }
                    ]
                }
            ]
        },
        {
            "line": "20. Males who are sexually active with women of childbearing potential must agree to follow instructions for method(s) of contraception for the duration of treatment with study treatment plus 90 days post-treatment completion.",
            "criterions": [
                {
                    "exact_snippets": "Males who are sexually active with women of childbearing potential",
                    "criterion": "sexually active males with women of childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "must agree to follow instructions for method(s) of contraception",
                    "criterion": "agreement to use contraception",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "for the duration of treatment with study treatment plus 90 days post-treatment completion",
                    "criterion": "duration of contraception use",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "duration of treatment plus 90 days post-treatment"
                        }
                    ]
                }
            ]
        },
        {
            "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. Known uncontrolled central nervous system (CNS) metastases and/or carcinomatous meningitis. Note: Patients with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least 4 weeks prior to the first dose of study treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are clinically stable off steroids for at least 7 days prior to study treatment. Carcinomatous meningitis precludes a patient from study participation regardless of clinical stability.",
            "criterions": [
                {
                    "exact_snippets": "Known uncontrolled central nervous system (CNS) metastases",
                    "criterion": "uncontrolled CNS metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "carcinomatous meningitis",
                    "criterion": "carcinomatous meningitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "previously treated brain metastases ... stable (without evidence of progression by imaging for at least 4 weeks prior to the first dose of study treatment",
                    "criterion": "previously treated brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "progression",
                            "expected_value": {
                                "operator": "<=",
                                "value": 0,
                                "unit": "weeks"
                            }
                        },
                        {
                            "requirement_type": "time since last progression",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "neurologic symptoms have returned to baseline",
                    "criterion": "neurologic symptoms",
                    "requirements": [
                        {
                            "requirement_type": "baseline",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "no evidence of new or enlarging brain metastases",
                    "criterion": "new or enlarging brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "clinically stable off steroids for at least 7 days prior to study treatment",
                    "criterion": "stability off steroids",
                    "requirements": [
                        {
                            "requirement_type": "time off steroids",
                            "expected_value": {
                                "operator": ">=",
                                "value": 7,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. History of acute coronary syndromes, including myocardial infarction, coronary artery bypass graft, unstable angina, coronary angioplasty or stenting within past 24 weeks.",
            "criterions": [
                {
                    "exact_snippets": "History of acute coronary syndromes, including myocardial infarction",
                    "criterion": "acute coronary syndromes",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "coronary artery bypass graft",
                    "criterion": "coronary artery bypass graft",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "unstable angina",
                    "criterion": "unstable angina",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "coronary angioplasty or stenting",
                    "criterion": "coronary angioplasty or stenting",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "within past 24 weeks",
                    "criterion": "time since event",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 24,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. History of or current Class II, III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system (Appendix B).",
            "criterions": [
                {
                    "exact_snippets": "History of or current Class II, III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system",
                    "criterion": "heart failure",
                    "requirements": [
                        {
                            "requirement_type": "history or current status",
                            "expected_value": [
                                "Class II",
                                "Class III",
                                "Class IV"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. History of ejection fraction drop below the lower limit of normal with trastuzumab and/or pertuzumab.",
            "criterions": [
                {
                    "exact_snippets": "History of ejection fraction drop below the lower limit of normal",
                    "criterion": "ejection fraction",
                    "requirements": [
                        {
                            "requirement_type": "history of drop",
                            "expected_value": "below the lower limit of normal"
                        }
                    ]
                },
                {
                    "exact_snippets": "trastuzumab and/or pertuzumab",
                    "criterion": "trastuzumab and/or pertuzumab",
                    "requirements": [
                        {
                            "requirement_type": "association",
                            "expected_value": "ejection fraction drop"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Medical, psychiatric, cognitive or other conditions that compromise the patient's ability to understand the patient information, to give informed consent, to comply with the study protocol or to complete the study.",
            "criterions": [
                {
                    "exact_snippets": "Medical, psychiatric, cognitive or other conditions that compromise the patient's ability to understand the patient information",
                    "criterion": "ability to understand patient information",
                    "requirements": [
                        {
                            "requirement_type": "compromise",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Medical, psychiatric, cognitive or other conditions that compromise the patient's ability ... to give informed consent",
                    "criterion": "ability to give informed consent",
                    "requirements": [
                        {
                            "requirement_type": "compromise",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Medical, psychiatric, cognitive or other conditions that compromise the patient's ability ... to comply with the study protocol",
                    "criterion": "ability to comply with the study protocol",
                    "requirements": [
                        {
                            "requirement_type": "compromise",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Medical, psychiatric, cognitive or other conditions that compromise the patient's ability ... to complete the study",
                    "criterion": "ability to complete the study",
                    "requirements": [
                        {
                            "requirement_type": "compromise",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Any severe concurrent disease or condition (includes active infections, cardiac arrhythmia, interstitial lung disease) that in the judgment of the Investigator would make study participation inappropriate for the patient.",
            "criterions": [
                {
                    "exact_snippets": "severe concurrent disease or condition",
                    "criterion": "severe concurrent disease or condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "active infections",
                    "criterion": "active infections",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "cardiac arrhythmia",
                    "criterion": "cardiac arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "interstitial lung disease",
                    "criterion": "interstitial lung disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Previously known infection with human immunodeficiency virus (HIV); or hepatitis B virus (HBV) or hepatitis C virus (HCV) (unless patients are HBV DNA / HCV RNA negative).",
            "criterions": [
                {
                    "exact_snippets": "Previously known infection with human immunodeficiency virus (HIV)",
                    "criterion": "HIV infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hepatitis B virus (HBV)",
                    "criterion": "HBV infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "HBV DNA",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "hepatitis C virus (HCV)",
                    "criterion": "HCV infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "HCV RNA",
                            "expected_value": "negative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Any severe infection within 28 days prior to Cycle 1 Day 1, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia or active tuberculosis.",
            "criterions": [
                {
                    "exact_snippets": "Any severe infection within 28 days prior to Cycle 1 Day 1",
                    "criterion": "severe infection",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "within 28 days prior to Cycle 1 Day 1"
                        }
                    ]
                },
                {
                    "exact_snippets": "hospitalization for complications of infection",
                    "criterion": "hospitalization for complications of infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "bacteremia",
                    "criterion": "bacteremia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "severe pneumonia",
                    "criterion": "severe pneumonia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "active tuberculosis",
                    "criterion": "active tuberculosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Administration of live, attenuated vaccines within 28 days before Cycle 1 Day 1 or anticipated need of vaccination with live attenuated vaccine during the study.",
            "criterions": [
                {
                    "exact_snippets": "Administration of live, attenuated vaccines within 28 days before Cycle 1 Day 1",
                    "criterion": "administration of live, attenuated vaccines",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": {
                                "operator": "<",
                                "value": 28,
                                "unit": "days before Cycle 1 Day 1"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "anticipated need of vaccination with live attenuated vaccine during the study",
                    "criterion": "need of vaccination with live attenuated vaccine",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "during the study"
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Need for the treatment of bacterial infection with oral or intravenous (IV) antibiotics within 14 days prior to Cycle 1 Day 1.",
            "criterions": [
                {
                    "exact_snippets": "Need for the treatment of bacterial infection",
                    "criterion": "bacterial infection",
                    "requirements": [
                        {
                            "requirement_type": "treatment necessity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "oral or intravenous (IV) antibiotics",
                    "criterion": "antibiotic treatment",
                    "requirements": [
                        {
                            "requirement_type": "route of administration",
                            "expected_value": [
                                "oral",
                                "intravenous"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "within 14 days prior to Cycle 1 Day 1",
                    "criterion": "timeframe for antibiotic treatment",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 14,
                                        "unit": "days"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. History of infusion reactions to any component/excipient of PRS-343.",
            "criterions": [
                {
                    "exact_snippets": "History of infusion reactions to any component/excipient of PRS-343.",
                    "criterion": "infusion reactions to PRS-343 components/excipients",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. History of infusion reactions to any component/excipient of atezolizumab.",
            "criterions": [
                {
                    "exact_snippets": "History of infusion reactions to any component/excipient of atezolizumab.",
                    "criterion": "infusion reactions to atezolizumab components/excipients",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. History of severe hypersensitivity reactions to monoclonal antibodies (mAbs).",
            "criterions": [
                {
                    "exact_snippets": "History of severe hypersensitivity reactions to monoclonal antibodies (mAbs).",
                    "criterion": "hypersensitivity reactions to monoclonal antibodies",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "14. Systemic steroid therapy (>10 mg daily prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment (note: topical, inhaled, nasal and ophthalmic steroids are not prohibited).",
            "criterions": [
                {
                    "exact_snippets": "Systemic steroid therapy (>10 mg daily prednisone or equivalent)",
                    "criterion": "systemic steroid therapy",
                    "requirements": [
                        {
                            "requirement_type": "dosage",
                            "expected_value": {
                                "operator": ">",
                                "value": 10,
                                "unit": "mg daily prednisone or equivalent"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment",
                    "criterion": "immunosuppressive therapy",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "within 7 days prior to the first dose of study treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "15. Autoimmune disease that has required systemic treatment in the past (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is allowed.",
            "criterions": [
                {
                    "exact_snippets": "Autoimmune disease that has required systemic treatment in the past",
                    "criterion": "autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "treatment history",
                            "expected_value": "systemic treatment in the past"
                        }
                    ]
                },
                {
                    "exact_snippets": "Replacement therapy ... is allowed",
                    "criterion": "replacement therapy",
                    "requirements": [
                        {
                            "requirement_type": "allowance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "16. Prior organ transplantation including allogeneic or autologous stem-cell transplantation.",
            "criterions": [
                {
                    "exact_snippets": "Prior organ transplantation",
                    "criterion": "organ transplantation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "allogeneic or autologous stem-cell transplantation",
                    "criterion": "stem-cell transplantation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "17. Has not recovered from the adverse effect of previous anticancer treatments to pre-treatment baseline or Grade 1 except for alopecia, anemia (hemoglobin must meet the study inclusion criteria) and peripheral neuropathy (which must have recovered to ≤ Grade 2) nausea and diarrhea if anti-emetic and anti-diarrheal treatment hasn't been exhausted.",
            "criterions": [
                {
                    "exact_snippets": "Has not recovered from the adverse effect of previous anticancer treatments to pre-treatment baseline or Grade 1",
                    "criterion": "recovery from adverse effects of previous anticancer treatments",
                    "requirements": [
                        {
                            "requirement_type": "recovery level",
                            "expected_value": [
                                "pre-treatment baseline",
                                "Grade 1"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "alopecia",
                    "criterion": "alopecia",
                    "requirements": [
                        {
                            "requirement_type": "recovery level",
                            "expected_value": "N/A"
                        }
                    ]
                },
                {
                    "exact_snippets": "anemia (hemoglobin must meet the study inclusion criteria)",
                    "criterion": "anemia",
                    "requirements": [
                        {
                            "requirement_type": "hemoglobin level",
                            "expected_value": "must meet the study inclusion criteria"
                        }
                    ]
                },
                {
                    "exact_snippets": "peripheral neuropathy (which must have recovered to ≤ Grade 2)",
                    "criterion": "peripheral neuropathy",
                    "requirements": [
                        {
                            "requirement_type": "recovery level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "Grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "nausea and diarrhea if anti-emetic and anti-diarrheal treatment hasn't been exhausted",
                    "criterion": "nausea and diarrhea",
                    "requirements": [
                        {
                            "requirement_type": "treatment exhaustion",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "18. Concurrent or previous other malignancy within 5 years of study entry with the exception of cured basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in-situ of the cervix, or other noninvasive or indolent malignancy.",
            "criterions": [
                {
                    "exact_snippets": "Concurrent or previous other malignancy within 5 years of study entry",
                    "criterion": "other malignancy",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "within 5 years of study entry"
                        },
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "concurrent",
                                "previous"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "cured basal or squamous cell skin cancer",
                    "criterion": "basal or squamous cell skin cancer",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "cured"
                        }
                    ]
                },
                {
                    "exact_snippets": "superficial bladder cancer",
                    "criterion": "bladder cancer",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "superficial"
                        }
                    ]
                },
                {
                    "exact_snippets": "prostate intraepithelial neoplasm",
                    "criterion": "prostate intraepithelial neoplasm",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "carcinoma in-situ of the cervix",
                    "criterion": "carcinoma in-situ of the cervix",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "other noninvasive or indolent malignancy",
                    "criterion": "other malignancy",
                    "requirements": [
                        {
                            "requirement_type": "invasiveness",
                            "expected_value": "noninvasive"
                        },
                        {
                            "requirement_type": "aggressiveness",
                            "expected_value": "indolent"
                        }
                    ]
                }
            ]
        },
        {
            "line": "19. Receipt of investigational treatment within 3 weeks of scheduled Cycle 1 Day 1 (C1D1) dosing.",
            "criterions": [
                {
                    "exact_snippets": "Receipt of investigational treatment within 3 weeks of scheduled Cycle 1 Day 1 (C1D1) dosing.",
                    "criterion": "investigational treatment",
                    "requirements": [
                        {
                            "requirement_type": "receipt",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "20. Receipt of cytotoxic chemotherapy within 3 weeks (6 weeks for nitrosoureas and mitomycin C) of scheduled C1D1 dosing.",
            "criterions": [
                {
                    "exact_snippets": "Receipt of cytotoxic chemotherapy within 3 weeks",
                    "criterion": "cytotoxic chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "(6 weeks for nitrosoureas and mitomycin C)",
                    "criterion": "nitrosoureas and mitomycin C",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "21. Receipt of radiation therapy within 3 weeks of scheduled Day 1 dosing, unless the radiation comprised a limited field to non-visceral structures (e.g., limb bone metastasis).",
            "criterions": [
                {
                    "exact_snippets": "Receipt of radiation therapy within 3 weeks of scheduled Day 1 dosing",
                    "criterion": "radiation therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "unless the radiation comprised a limited field to non-visceral structures (e.g., limb bone metastasis)",
                    "criterion": "radiation field",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "non-visceral structures"
                        }
                    ]
                }
            ]
        },
        {
            "line": "22. Receipt of treatment with immunotherapy, biological therapies, hormonal therapies within 3 weeks of scheduled C1D1 dosing.",
            "criterions": [
                {
                    "exact_snippets": "Receipt of treatment with immunotherapy",
                    "criterion": "immunotherapy treatment",
                    "requirements": [
                        {
                            "requirement_type": "receipt",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Receipt of treatment with ... biological therapies",
                    "criterion": "biological therapies treatment",
                    "requirements": [
                        {
                            "requirement_type": "receipt",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Receipt of treatment with ... hormonal therapies",
                    "criterion": "hormonal therapies treatment",
                    "requirements": [
                        {
                            "requirement_type": "receipt",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "23. Treatment with targeted small molecules within 5 half-lives of scheduled C1D1 dosing.",
            "criterions": [
                {
                    "exact_snippets": "Treatment with targeted small molecules within 5 half-lives of scheduled C1D1 dosing.",
                    "criterion": "treatment with targeted small molecules",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "half-lives"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "24. Receipt of trastuzumab or ado-trastuzumab emtansine or any other experimental drug that engages the same epitope as trastuzumab within 4 weeks of scheduled C1D1 dosing.",
            "criterions": [
                {
                    "exact_snippets": "Receipt of trastuzumab",
                    "criterion": "trastuzumab receipt",
                    "requirements": [
                        {
                            "requirement_type": "time since last dose",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "ado-trastuzumab emtansine",
                    "criterion": "ado-trastuzumab emtansine receipt",
                    "requirements": [
                        {
                            "requirement_type": "time since last dose",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "any other experimental drug that engages the same epitope as trastuzumab",
                    "criterion": "experimental drug engaging trastuzumab epitope receipt",
                    "requirements": [
                        {
                            "requirement_type": "time since last dose",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "25. Receipt of atezolizumab or any other experimental drug that engages the same epitope as atezolizumab within 4 weeks of scheduled C1D1 dosing.",
            "criterions": [
                {
                    "exact_snippets": "Receipt of atezolizumab",
                    "criterion": "atezolizumab receipt",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "any other experimental drug that engages the same epitope as atezolizumab",
                    "criterion": "experimental drug engaging same epitope as atezolizumab",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "within 4 weeks of scheduled C1D1 dosing",
                    "criterion": "time since last drug receipt",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "26. Concurrent enrollment in another therapeutic clinical trial.",
            "criterions": [
                {
                    "exact_snippets": "Concurrent enrollment in another therapeutic clinical trial",
                    "criterion": "enrollment in another therapeutic clinical trial",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "27. Major surgery within 3 weeks of scheduled C1D1 dosing.",
            "criterions": [
                {
                    "exact_snippets": "Major surgery within 3 weeks of scheduled C1D1 dosing.",
                    "criterion": "major surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since surgery",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "9. Serum AST and ALT ≤ 2.5 X ULN or ≤ 5 X ULN in the presence of liver metastases.",
            "criterions": [
                {
                    "exact_snippets": "Serum AST ... ≤ 2.5 X ULN or ≤ 5 X ULN in the presence of liver metastases.",
                    "criterion": "serum AST",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 2.5,
                                        "unit": "X ULN"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Serum ALT ... ≤ 2.5 X ULN or ≤ 5 X ULN in the presence of liver metastases.",
                    "criterion": "serum ALT",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 2.5,
                                        "unit": "X ULN"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Serum AST and ALT ... ≤ 5 X ULN in the presence of liver metastases.",
                    "criterion": "serum AST and ALT in the presence of liver metastases",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "X ULN"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}