{
    "info": {
        "nct_id": "NCT04682431",
        "official_title": "A Phase 1a/1b Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PY159 as a Single Agent and In Combination With Pembrolizumab in Subjects With Advanced Solid Tumors",
        "inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "KEY ELIGIBILITY CRITERIA Inclusion Criteria\n\n* Adults ≥18 years of age at the time of study consent\n* Subjects with any of the following eligible solid tumor diagnoses as confirmed by cytology or histology. Escalation Cohorts (Part A): Subjects with advanced solid tumors from pre-specified tumor types:\n\n  * head and neck [squamous cell carcinoma, salivary gland, thyroid],\n  * gynecologic [including ovarian, fallopian, primary peritoneal, endometrial, cervical, uterine, vaginal, vulvar],\n  * pancreatic [adenocarcinoma],\n  * lung [adenocarcinoma and squamous cell carcinoma] who are recurrent or refractory to platinum-based chemotherapy in addition to prior treatment with CPI Programmed Cell Death-1 (PD-1)/Programmed Cell Death-Ligand 1 (PD-L1) or who give informed consent to forego such therapy,\n  * gastric and esophagogastric junction adenocarcinomas [MSI low and CPI refractory MSI high],\n  * breast [TNBC and HR+, HER2-] with metastatic disease that is relapsed or refractory to at least one line of post adjuvant therapy (including a CPI-either alone or in combination, if approved for that indication, and not eligible for other targeted therapies specific for their tumor type).\n* Subjects must provide an original, diagnostic tumor sample to determine TREM1 expression (sites have verified source prior to screening and availability of archival tissue during screening). For Part A subjects without an archival tissue sample will only be eligible if they choose and consent to provide a CNB of a primary or metastatic lesion.\n* Subjects must have documented radiographic disease progression that include prior treatment with a CPI (alone or in combination), if approved for that indication.\n* There is no limit to the number of prior treatments\n* Measurable disease by RECIST 1.1.\n* All acute toxic effects of any prior antitumor therapy, including immunotherapy, have resolved to Grade < 2 before the start of study drug dosing (except for alopecia or peripheral neuropathy which may be Grade <2 or medication controlled thyroid replacement therapy).\n* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 2.\n\nExclusion Criteria\n\n* Subject is a candidate for approved molecularly targeted therapy (e.g., drugs targeting EGFR,VEGF, ALK, ROS-1, NTRK, MET, RET, and BRAF V600E, HER2). Applies to enrolled subjects on both Part A and Part B of the study.\n* History of autoimmune disorder requiring ongoing or intermittent disease-modifying therapy excluding thyroid disease well controlled on replacement therapy.\n* Untreated and/or uncontrolled brain metastases Stable treated or asymptomatic brain metastases (for at least 1 month prior to enrollment may be enrolled. Subjects with stable treated or asymptomatic brain metastases receiving glucocorticoids must be on a stable dose [≤ 2 mg/day of dexamethasone or an equivalent glucocorticoid] for a minimum of 1month prior to enrollment.)\n* Uncontrolled intercurrent illness including, but not limited to, active SARS-CoV-2 infection, active or chronic bleeding event within 28 days prior to first dose of study drug or psychiatric illness/social situation that would limit compliance with study requirements as judged by treating physician.\n* Decompensated liver disease as evidenced by hepatic encephalopathy or coagulopathy.\n* Active angina or Class III or IV Congestive Heart Failure (CHF) (NYHA CHF Functional Classification System) or clinically significant cardiac disease within 12 months of first dose. of study drug, including MI, unstable angina, Grade 2 or greater peripheral vascular disease, uncontrolled HTN, or arrhythmias not controlled by medication.\n* Any anti-cancer therapy, including small molecules, immunotherapy, chemotherapy, monoclonal antibody therapy (with the exception of bone-modifying agents as supportive care), radiotherapy or any other agents to treat cancer within 14-21 days (dependent upon the agent and drug half-life) of first dose of study drug. Subjects with a prior history of prostate cancer on LHRH agonist are eligible provided they have no evidence of metastatic disease.\n\nNote: Other protocol defined Inclusion/Exclusion criteria may apply."
    },
    "inclusion_lines": [
        {
            "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": [],
    "miscellaneous_lines": [
        {
            "line": "* Adults ≥18 years of age at the time of study consent",
            "criterions": [
                {
                    "exact_snippets": "Adults ≥18 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects with any of the following eligible solid tumor diagnoses as confirmed by cytology or histology. Escalation Cohorts (Part A): Subjects with advanced solid tumors from pre-specified tumor types:",
            "criterions": [
                {
                    "exact_snippets": "Subjects with any of the following eligible solid tumor diagnoses",
                    "criterion": "solid tumor diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "as confirmed by cytology or histology",
                    "criterion": "confirmation method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "cytology",
                                "histology"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Escalation Cohorts (Part A): Subjects with advanced solid tumors",
                    "criterion": "advanced solid tumors",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* head and neck [squamous cell carcinoma, salivary gland, thyroid],",
            "criterions": [
                {
                    "exact_snippets": "head and neck [squamous cell carcinoma, salivary gland, thyroid]",
                    "criterion": "head and neck cancer type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "squamous cell carcinoma",
                                "salivary gland",
                                "thyroid"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* gynecologic [including ovarian, fallopian, primary peritoneal, endometrial, cervical, uterine, vaginal, vulvar],",
            "criterions": [
                {
                    "exact_snippets": "gynecologic [including ovarian, fallopian, primary peritoneal, endometrial, cervical, uterine, vaginal, vulvar]",
                    "criterion": "gynecologic cancer type",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "ovarian",
                                "fallopian",
                                "primary peritoneal",
                                "endometrial",
                                "cervical",
                                "uterine",
                                "vaginal",
                                "vulvar"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* pancreatic [adenocarcinoma],",
            "criterions": [
                {
                    "exact_snippets": "pancreatic [adenocarcinoma]",
                    "criterion": "pancreatic adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* lung [adenocarcinoma and squamous cell carcinoma] who are recurrent or refractory to platinum-based chemotherapy in addition to prior treatment with CPI Programmed Cell Death-1 (PD-1)/Programmed Cell Death-Ligand 1 (PD-L1) or who give informed consent to forego such therapy,",
            "criterions": [
                {
                    "exact_snippets": "lung [adenocarcinoma and squamous cell carcinoma]",
                    "criterion": "lung cancer type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "adenocarcinoma",
                                "squamous cell carcinoma"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "recurrent or refractory to platinum-based chemotherapy",
                    "criterion": "response to platinum-based chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "response",
                            "expected_value": [
                                "recurrent",
                                "refractory"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "prior treatment with CPI Programmed Cell Death-1 (PD-1)/Programmed Cell Death-Ligand 1 (PD-L1)",
                    "criterion": "prior treatment with CPI PD-1/PD-L1",
                    "requirements": [
                        {
                            "requirement_type": "treatment history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "give informed consent to forego such therapy",
                    "criterion": "informed consent to forego PD-1/PD-L1 therapy",
                    "requirements": [
                        {
                            "requirement_type": "consent",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* gastric and esophagogastric junction adenocarcinomas [MSI low and CPI refractory MSI high],",
            "criterions": [
                {
                    "exact_snippets": "gastric and esophagogastric junction adenocarcinomas",
                    "criterion": "adenocarcinomas",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": [
                                "gastric",
                                "esophagogastric junction"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "MSI low",
                    "criterion": "MSI status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "low"
                        }
                    ]
                },
                {
                    "exact_snippets": "CPI refractory MSI high",
                    "criterion": "CPI refractory MSI status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "high"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* breast [TNBC and HR+, HER2-] with metastatic disease that is relapsed or refractory to at least one line of post adjuvant therapy (including a CPI-either alone or in combination, if approved for that indication, and not eligible for other targeted therapies specific for their tumor type).",
            "criterions": [
                {
                    "exact_snippets": "breast [TNBC and HR+, HER2-]",
                    "criterion": "breast cancer subtype",
                    "requirements": [
                        {
                            "requirement_type": "subtype",
                            "expected_value": [
                                "TNBC",
                                "HR+, HER2-"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "metastatic disease",
                    "criterion": "metastatic disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "relapsed or refractory to at least one line of post adjuvant therapy",
                    "criterion": "response to post adjuvant therapy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "relapsed",
                                "refractory"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "CPI-either alone or in combination, if approved for that indication",
                    "criterion": "CPI treatment",
                    "requirements": [
                        {
                            "requirement_type": "approval status",
                            "expected_value": "approved for that indication"
                        }
                    ]
                },
                {
                    "exact_snippets": "not eligible for other targeted therapies specific for their tumor type",
                    "criterion": "eligibility for targeted therapies",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects must provide an original, diagnostic tumor sample to determine TREM1 expression (sites have verified source prior to screening and availability of archival tissue during screening). For Part A subjects without an archival tissue sample will only be eligible if they choose and consent to provide a CNB of a primary or metastatic lesion.",
            "criterions": [
                {
                    "exact_snippets": "Subjects must provide an original, diagnostic tumor sample",
                    "criterion": "original diagnostic tumor sample",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "to determine TREM1 expression",
                    "criterion": "TREM1 expression",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "availability of archival tissue during screening",
                    "criterion": "archival tissue",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Part A subjects without an archival tissue sample will only be eligible if they choose and consent to provide a CNB of a primary or metastatic lesion",
                    "criterion": "CNB of a primary or metastatic lesion",
                    "requirements": [
                        {
                            "requirement_type": "consent",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects must have documented radiographic disease progression that include prior treatment with a CPI (alone or in combination), if approved for that indication.",
            "criterions": [
                {
                    "exact_snippets": "documented radiographic disease progression",
                    "criterion": "radiographic disease progression",
                    "requirements": [
                        {
                            "requirement_type": "documentation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "prior treatment with a CPI (alone or in combination)",
                    "criterion": "prior treatment with a CPI",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* There is no limit to the number of prior treatments",
            "criterions": [
                {
                    "exact_snippets": "no limit to the number of prior treatments",
                    "criterion": "prior treatments",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": "no limit"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Measurable disease by RECIST 1.1.",
            "criterions": [
                {
                    "exact_snippets": "Measurable disease by RECIST 1.1.",
                    "criterion": "disease",
                    "requirements": [
                        {
                            "requirement_type": "measurability",
                            "expected_value": "RECIST 1.1"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* All acute toxic effects of any prior antitumor therapy, including immunotherapy, have resolved to Grade < 2 before the start of study drug dosing (except for alopecia or peripheral neuropathy which may be Grade <2 or medication controlled thyroid replacement therapy).",
            "criterions": [
                {
                    "exact_snippets": "All acute toxic effects of any prior antitumor therapy, including immunotherapy, have resolved to Grade < 2",
                    "criterion": "acute toxic effects of prior antitumor therapy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "Grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "alopecia ... may be Grade <2",
                    "criterion": "alopecia",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "Grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "peripheral neuropathy ... may be Grade <2",
                    "criterion": "peripheral neuropathy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "Grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "medication controlled thyroid replacement therapy",
                    "criterion": "thyroid replacement therapy",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "medication controlled"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 2.",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 2",
                    "criterion": "ECOG Performance Status",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subject is a candidate for approved molecularly targeted therapy (e.g., drugs targeting EGFR,VEGF, ALK, ROS-1, NTRK, MET, RET, and BRAF V600E, HER2). Applies to enrolled subjects on both Part A and Part B of the study.",
            "criterions": [
                {
                    "exact_snippets": "candidate for approved molecularly targeted therapy (e.g., drugs targeting EGFR,VEGF, ALK, ROS-1, NTRK, MET, RET, and BRAF V600E, HER2)",
                    "criterion": "molecularly targeted therapy eligibility",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of autoimmune disorder requiring ongoing or intermittent disease-modifying therapy excluding thyroid disease well controlled on replacement therapy.",
            "criterions": [
                {
                    "exact_snippets": "History of autoimmune disorder",
                    "criterion": "autoimmune disorder",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "requiring ongoing or intermittent disease-modifying therapy",
                    "criterion": "disease-modifying therapy",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "excluding thyroid disease well controlled on replacement therapy",
                    "criterion": "thyroid disease",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "well controlled on replacement therapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Untreated and/or uncontrolled brain metastases Stable treated or asymptomatic brain metastases (for at least 1 month prior to enrollment may be enrolled. Subjects with stable treated or asymptomatic brain metastases receiving glucocorticoids must be on a stable dose [≤ 2 mg/day of dexamethasone or an equivalent glucocorticoid] for a minimum of 1month prior to enrollment.)",
            "criterions": [
                {
                    "exact_snippets": "Untreated and/or uncontrolled brain metastases",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "untreated or uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "Stable treated or asymptomatic brain metastases (for at least 1 month prior to enrollment may be enrolled.",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "stable treated or asymptomatic"
                        },
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "month"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Subjects with stable treated or asymptomatic brain metastases receiving glucocorticoids must be on a stable dose [≤ 2 mg/day of dexamethasone or an equivalent glucocorticoid] for a minimum of 1month prior to enrollment.",
                    "criterion": "glucocorticoid dose",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "dose",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "mg/day"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Uncontrolled intercurrent illness including, but not limited to, active SARS-CoV-2 infection, active or chronic bleeding event within 28 days prior to first dose of study drug or psychiatric illness/social situation that would limit compliance with study requirements as judged by treating physician.",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled intercurrent illness including, but not limited to, active SARS-CoV-2 infection",
                    "criterion": "SARS-CoV-2 infection",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "active"
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrolled intercurrent illness including, but not limited to, ... active or chronic bleeding event within 28 days prior to first dose of study drug",
                    "criterion": "bleeding event",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "active",
                                "chronic"
                            ]
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 28 days prior to first dose of study drug"
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrolled intercurrent illness including, but not limited to, ... psychiatric illness/social situation that would limit compliance with study requirements as judged by treating physician",
                    "criterion": "psychiatric illness/social situation",
                    "requirements": [
                        {
                            "requirement_type": "impact",
                            "expected_value": "limit compliance with study requirements"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Decompensated liver disease as evidenced by hepatic encephalopathy or coagulopathy.",
            "criterions": [
                {
                    "exact_snippets": "Decompensated liver disease",
                    "criterion": "liver disease",
                    "requirements": [
                        {
                            "requirement_type": "compensation status",
                            "expected_value": "decompensated"
                        }
                    ]
                },
                {
                    "exact_snippets": "hepatic encephalopathy",
                    "criterion": "hepatic encephalopathy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "coagulopathy",
                    "criterion": "coagulopathy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active angina or Class III or IV Congestive Heart Failure (CHF) (NYHA CHF Functional Classification System) or clinically significant cardiac disease within 12 months of first dose. of study drug, including MI, unstable angina, Grade 2 or greater peripheral vascular disease, uncontrolled HTN, or arrhythmias not controlled by medication.",
            "criterions": [
                {
                    "exact_snippets": "Active angina",
                    "criterion": "angina",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    ]
                },
                {
                    "exact_snippets": "Class III or IV Congestive Heart Failure (CHF) (NYHA CHF Functional Classification System)",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "class",
                            "expected_value": [
                                "III",
                                "IV"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "clinically significant cardiac disease within 12 months of first dose",
                    "criterion": "cardiac disease",
                    "requirements": [
                        {
                            "requirement_type": "clinical significance",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 12 months of first dose"
                        }
                    ]
                },
                {
                    "exact_snippets": "MI",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "unstable angina",
                    "criterion": "angina",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": "unstable"
                        }
                    ]
                },
                {
                    "exact_snippets": "Grade 2 or greater peripheral vascular disease",
                    "criterion": "peripheral vascular disease",
                    "requirements": [
                        {
                            "requirement_type": "grade",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled HTN",
                    "criterion": "hypertension",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "arrhythmias not controlled by medication",
                    "criterion": "arrhythmias",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "not controlled by medication"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any anti-cancer therapy, including small molecules, immunotherapy, chemotherapy, monoclonal antibody therapy (with the exception of bone-modifying agents as supportive care), radiotherapy or any other agents to treat cancer within 14-21 days (dependent upon the agent and drug half-life) of first dose of study drug. Subjects with a prior history of prostate cancer on LHRH agonist are eligible provided they have no evidence of metastatic disease.",
            "criterions": [
                {
                    "exact_snippets": "Any anti-cancer therapy, including small molecules, immunotherapy, chemotherapy, monoclonal antibody therapy ... within 14-21 days ... of first dose of study drug.",
                    "criterion": "anti-cancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 14,
                                        "unit": "days"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 21,
                                        "unit": "days"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Subjects with a prior history of prostate cancer on LHRH agonist are eligible provided they have no evidence of metastatic disease.",
                    "criterion": "prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "LHRH agonist"
                        },
                        {
                            "requirement_type": "metastatic disease",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "Note: Other protocol defined Inclusion/Exclusion criteria may apply.",
            "criterions": [
                {
                    "exact_snippets": "Other protocol defined Inclusion/Exclusion criteria",
                    "criterion": "protocol defined Inclusion/Exclusion criteria",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "KEY ELIGIBILITY CRITERIA Inclusion Criteria",
            "criterions": []
        },
        {
            "line": "Exclusion Criteria",
            "criterions": []
        }
    ]
}