{
    "info": {
        "nct_id": "NCT02929862",
        "official_title": "A Phase 1/2A Multicenter, Open-Label Study of LYC-55716 in Adult Subjects With Locally Advanced or Metastatic Cancer",
        "inclusion_criteria": "* Subject is male or female and at least 18 years of age.\n* Histological or cytological confirmation of advanced unresectable solid tumors, including those subjects who have progressed on standard anticancer therapy and for whom no further therapy that confers clinical benefit is available.\n* Subject has an Eastern Cooperative Oncology Group (ECOG) score of 0 1 or Karnofsky Performance Status Score ≥ 70.\n* Subject has a life expectancy of at least 12 weeks.\n* Subject has adequate organ function as determined by the following laboratory values:\n\n  * Absolute Neutrophil Count* ≥ 1,500/mm3 (≥ 1.5 x 109/L)\n  * Platelets* ≥ 100,000/mm3 (≥ 100 x 109/L)\n  * Lymphocytes ≥ 0.5 x 109/L\n  * Hemoglobin* > 9.0 g/dL\n  * Serum Creatinine or Creatinine Clearance** ≤ 1.5 x ULN, > 50 mL/min\n  * Total Serum Bilirubin ≤ 1.5 x ULN (< 3.0 mg/dL if subject has Gilbert's syndrome)\n  * Liver Transaminases (ALT/AST) ≤ 2.5 x ULN, ≤ 5.0 x ULN if liver metastases present\n\n    * (* = without ongoing growth factor or transfusion support)\n    * (** = calculated by Cockcroft and Gault's formula)\n    * (ALT = alanine aminotransferase, AST = aspartate aminotransferase, ULN = upper limit of normal)\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Subject has received an investigational drug in the 28 day period before the first dose of study drug (or within 5 half-lives if longer) or is currently participating in another interventional clinical trial.\n* Subject has known symptomatic brain metastases or leptomeningeal involvement as assessed by CT scan or MRI. Subjects with stable asymptomatic brain metastases or leptomeningeal disease are eligible if they have not required new treatments for this disease in a 28 day period before the first dose of study drug, and anticonvulsants and steroids have not been administered for a period of 2 weeks prior to the first dose of study drug.\n* Subject has not recovered from adverse reactions to prior cancer treatment or procedures (surgery, chemotherapy, immunotherapy, radiation therapy) to Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 or better.\n* Subject has a previous (within 5 years) or current malignancy other than the target cancer with the exception of curatively treated local tumors such as carcinoma in situ of the breast or cervix, basal or squamous cell carcinoma of the skin, or prostate cancer with Gleason Grade < 6 and prostate-specific antigen within normal range.\n\nModifications to Eligibility Criteria for the following specific tumor types:\n\nPhase 2A will be limited to enrolling the following tumor types:\n\n* NSCLC\n* Gastric, Esophageal, and G-E Junction Adenocarcinoma\n* SCCHN\n* Ovarian Carcinoma\n* Renal Cell Carcinoma\n* Urothelial Carcinoma",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Subject is male or female and at least 18 years of age.",
            "criterions": [
                {
                    "exact_snippets": "Subject is male or female",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "at least 18 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Histological or cytological confirmation of advanced unresectable solid tumors, including those subjects who have progressed on standard anticancer therapy and for whom no further therapy that confers clinical benefit is available.",
            "criterions": [
                {
                    "exact_snippets": "Histological or cytological confirmation of advanced unresectable solid tumors",
                    "criterion": "advanced unresectable solid tumors",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": [
                                "histological",
                                "cytological"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "subjects who have progressed on standard anticancer therapy",
                    "criterion": "progression on standard anticancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "progression",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "no further therapy that confers clinical benefit is available",
                    "criterion": "availability of further therapy conferring clinical benefit",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subject has an Eastern Cooperative Oncology Group (ECOG) score of 0 1 or Karnofsky Performance Status Score ≥ 70.",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) score of 0 1",
                    "criterion": "ECOG score",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Karnofsky Performance Status Score ≥ 70",
                    "criterion": "Karnofsky Performance Status Score",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 70,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subject has a life expectancy of at least 12 weeks.",
            "criterions": [
                {
                    "exact_snippets": "life expectancy of at least 12 weeks",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subject has adequate organ function as determined by the following laboratory values:",
            "criterions": [
                {
                    "exact_snippets": "adequate organ function",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Absolute Neutrophil Count* ≥ 1,500/mm3 (≥ 1.5 x 109/L)",
            "criterions": [
                {
                    "exact_snippets": "Absolute Neutrophil Count* ≥ 1,500/mm3 (≥ 1.5 x 109/L)",
                    "criterion": "Absolute Neutrophil Count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1500,
                                        "unit": "mm3"
                                    },
                                    {
                                        "operator": ">=",
                                        "value": 1.5,
                                        "unit": "x 10^9/L"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Platelets* ≥ 100,000/mm3 (≥ 100 x 109/L)",
            "criterions": [
                {
                    "exact_snippets": "Platelets* ≥ 100,000/mm3 (≥ 100 x 109/L)",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "mm3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Lymphocytes ≥ 0.5 x 109/L",
            "criterions": [
                {
                    "exact_snippets": "Lymphocytes ≥ 0.5 x 109/L",
                    "criterion": "lymphocytes",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 0.5,
                                "unit": "x 10^9/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hemoglobin* > 9.0 g/dL",
            "criterions": [
                {
                    "exact_snippets": "Hemoglobin* > 9.0 g/dL",
                    "criterion": "hemoglobin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 9.0,
                                "unit": "g/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serum Creatinine or Creatinine Clearance** ≤ 1.5 x ULN, > 50 mL/min",
            "criterions": [
                {
                    "exact_snippets": "Serum Creatinine ... ≤ 1.5 x ULN",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Creatinine Clearance ... > 50 mL/min",
                    "criterion": "creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "rate",
                            "expected_value": {
                                "operator": ">",
                                "value": 50,
                                "unit": "mL/min"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Total Serum Bilirubin ≤ 1.5 x ULN (< 3.0 mg/dL if subject has Gilbert's syndrome)",
            "criterions": [
                {
                    "exact_snippets": "Total Serum Bilirubin ≤ 1.5 x ULN",
                    "criterion": "total serum bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 1.5,
                                        "unit": "x ULN"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "< 3.0 mg/dL if subject has Gilbert's syndrome",
                    "criterion": "total serum bilirubin in subjects with Gilbert's syndrome",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 3.0,
                                        "unit": "mg/dL"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Liver Transaminases (ALT/AST) ≤ 2.5 x ULN, ≤ 5.0 x ULN if liver metastases present",
            "criterions": [
                {
                    "exact_snippets": "Liver Transaminases (ALT/AST) ≤ 2.5 x ULN",
                    "criterion": "Liver Transaminases (ALT/AST)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Liver Transaminases (ALT/AST) ... ≤ 5.0 x ULN if liver metastases present",
                    "criterion": "Liver Transaminases (ALT/AST) with liver metastases",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5.0,
                                "unit": "x ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* (* = without ongoing growth factor or transfusion support)",
            "criterions": [
                {
                    "exact_snippets": "without ongoing growth factor or transfusion support",
                    "criterion": "growth factor or transfusion support",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* (** = calculated by Cockcroft and Gault's formula)",
            "criterions": [
                {
                    "exact_snippets": "calculated by Cockcroft and Gault's formula",
                    "criterion": "creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "calculation method",
                            "expected_value": "Cockcroft and Gault's formula"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* (ALT = alanine aminotransferase, AST = aspartate aminotransferase, ULN = upper limit of normal)",
            "criterions": [
                {
                    "exact_snippets": "ALT = alanine aminotransferase",
                    "criterion": "ALT",
                    "requirements": [
                        {
                            "requirement_type": "definition",
                            "expected_value": "alanine aminotransferase"
                        }
                    ]
                },
                {
                    "exact_snippets": "AST = aspartate aminotransferase",
                    "criterion": "AST",
                    "requirements": [
                        {
                            "requirement_type": "definition",
                            "expected_value": "aspartate aminotransferase"
                        }
                    ]
                },
                {
                    "exact_snippets": "ULN = upper limit of normal",
                    "criterion": "ULN",
                    "requirements": [
                        {
                            "requirement_type": "definition",
                            "expected_value": "upper limit of normal"
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Subject has received an investigational drug in the 28 day period before the first dose of study drug (or within 5 half-lives if longer) or is currently participating in another interventional clinical trial.",
            "criterions": [
                {
                    "exact_snippets": "Subject has received an investigational drug in the 28 day period before the first dose of study drug",
                    "criterion": "prior investigational drug use",
                    "requirements": [
                        {
                            "requirement_type": "time since last dose",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 28,
                                        "unit": "days"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Subject has received an investigational drug ... within 5 half-lives if longer",
                    "criterion": "prior investigational drug use",
                    "requirements": [
                        {
                            "requirement_type": "time since last dose",
                            "expected_value": "within 5 half-lives if longer"
                        }
                    ]
                },
                {
                    "exact_snippets": "currently participating in another interventional clinical trial",
                    "criterion": "current participation in another interventional clinical trial",
                    "requirements": [
                        {
                            "requirement_type": "participation status",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subject has known symptomatic brain metastases or leptomeningeal involvement as assessed by CT scan or MRI. Subjects with stable asymptomatic brain metastases or leptomeningeal disease are eligible if they have not required new treatments for this disease in a 28 day period before the first dose of study drug, and anticonvulsants and steroids have not been administered for a period of 2 weeks prior to the first dose of study drug.",
            "criterions": [
                {
                    "exact_snippets": "known symptomatic brain metastases",
                    "criterion": "symptomatic brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "leptomeningeal involvement",
                    "criterion": "leptomeningeal involvement",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "stable asymptomatic brain metastases",
                    "criterion": "stable asymptomatic brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": "stable"
                        },
                        {
                            "requirement_type": "symptoms",
                            "expected_value": "asymptomatic"
                        }
                    ]
                },
                {
                    "exact_snippets": "stable asymptomatic ... leptomeningeal disease",
                    "criterion": "stable asymptomatic leptomeningeal disease",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": "stable"
                        },
                        {
                            "requirement_type": "symptoms",
                            "expected_value": "asymptomatic"
                        }
                    ]
                },
                {
                    "exact_snippets": "have not required new treatments for this disease in a 28 day period before the first dose of study drug",
                    "criterion": "new treatments for brain metastases or leptomeningeal disease",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "anticonvulsants ... have not been administered for a period of 2 weeks prior to the first dose of study drug",
                    "criterion": "anticonvulsant administration",
                    "requirements": [
                        {
                            "requirement_type": "time since last administration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "steroids have not been administered for a period of 2 weeks prior to the first dose of study drug",
                    "criterion": "steroid administration",
                    "requirements": [
                        {
                            "requirement_type": "time since last administration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subject has not recovered from adverse reactions to prior cancer treatment or procedures (surgery, chemotherapy, immunotherapy, radiation therapy) to Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 or better.",
            "criterions": [
                {
                    "exact_snippets": "Subject has not recovered from adverse reactions to prior cancer treatment or procedures (surgery, chemotherapy, immunotherapy, radiation therapy)",
                    "criterion": "recovery from adverse reactions to prior cancer treatment or procedures",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "CTCAE Grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subject has a previous (within 5 years) or current malignancy other than the target cancer with the exception of curatively treated local tumors such as carcinoma in situ of the breast or cervix, basal or squamous cell carcinoma of the skin, or prostate cancer with Gleason Grade < 6 and prostate-specific antigen within normal range.",
            "criterions": [
                {
                    "exact_snippets": "previous (within 5 years) or current malignancy other than the target cancer",
                    "criterion": "previous or current malignancy",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "years"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "exclusion",
                            "expected_value": [
                                "target cancer"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "curatively treated local tumors such as carcinoma in situ of the breast or cervix, basal or squamous cell carcinoma of the skin, or prostate cancer with Gleason Grade < 6 and prostate-specific antigen within normal range",
                    "criterion": "curatively treated local tumors",
                    "requirements": [
                        {
                            "requirement_type": "examples",
                            "expected_value": [
                                "carcinoma in situ of the breast",
                                "carcinoma in situ of the cervix",
                                "basal cell carcinoma of the skin",
                                "squamous cell carcinoma of the skin"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "prostate cancer with Gleason Grade < 6",
                    "criterion": "prostate cancer Gleason Grade",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<",
                                "value": 6,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "prostate-specific antigen within normal range",
                    "criterion": "prostate-specific antigen",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": "within normal range"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Modifications to Eligibility Criteria for the following specific tumor types:",
            "criterions": [
                {
                    "exact_snippets": "specific tumor types",
                    "criterion": "tumor type",
                    "requirements": [
                        {
                            "requirement_type": "modification",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Phase 2A will be limited to enrolling the following tumor types:",
            "criterions": [
                {
                    "exact_snippets": "enrolling the following tumor types",
                    "criterion": "tumor types",
                    "requirements": [
                        {
                            "requirement_type": "enrollment",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* NSCLC",
            "criterions": [
                {
                    "exact_snippets": "NSCLC",
                    "criterion": "NSCLC",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Gastric, Esophageal, and G-E Junction Adenocarcinoma",
            "criterions": [
                {
                    "exact_snippets": "Gastric",
                    "criterion": "gastric adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Esophageal",
                    "criterion": "esophageal adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "G-E Junction",
                    "criterion": "gastroesophageal junction adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* SCCHN",
            "criterions": [
                {
                    "exact_snippets": "SCCHN",
                    "criterion": "SCCHN",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Ovarian Carcinoma",
            "criterions": [
                {
                    "exact_snippets": "Ovarian Carcinoma",
                    "criterion": "Ovarian Carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Renal Cell Carcinoma",
            "criterions": [
                {
                    "exact_snippets": "Renal Cell Carcinoma",
                    "criterion": "Renal Cell Carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Urothelial Carcinoma",
            "criterions": [
                {
                    "exact_snippets": "Urothelial Carcinoma",
                    "criterion": "Urothelial Carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}