{
    "info": {
        "nct_id": "NCT06251973",
        "official_title": "A Phase II Study of agenT-797 (Invariant Natural Killer T Cells), Botensilimab, a Novel Fc-enhanced CTLA-4 Inhibitor, Plus Balstilimab (Anti-PD-1) With Ramucirumab and Paclitaxel for Patients With Previously Treated, Advanced Esophageal, Gastric, or Gastro-esophageal Junction Adenocarcinoma",
        "inclusion_criteria": "* Metastatic or advanced unresectable adenocarcinoma of esophageal, gastric, or gastroesophageal junction\n* Disease progression on one prior line of therapy for metastatic disease. Patients with previously untreated advanced unresectable or metastatic disease may be included if disease progressed or recurred during neoadjuvant or adjuvant therapy or within 6 months of completion of those treatments.\n* Patients must have histologically or cytologically confirmed esophageal, gastric, or gastroesophageal junction adenocarcinoma\n* Patients must have measurable or evaluable disease as defined by RECIST v1.1 criteria. Patients with evaluable disease must be eligible to begin with an induction cycle\n* Age 18 years or older\n* ECOG performance status 0 to 1\n* Adequate organ function as defined in Table 2\n\nTable 2. Organ function requirements for eligibility Hematological Absolute neutrophil count: ≥1000/mcL Platelets: ≥90,000/mcL Hemoglobin: ≥8 g/dL Renal Serum creatinine: ≤1.5X ULN Hepatic Serum total bilirubin: ≤1.5X ULN OR Direct bilirubin ≤ULN for subjects with total bilirubin levels >1.5X ULN, except patients with Gilbert's disease (≤3X ULN) AST and ALT: ≤2.5X ULN Albumin: ≥3 mg/dL\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Received prior therapy with ramucirumab at any time\n* Received paclitaxel or docetaxel-based therapy within 6 month of study enrollment\n* Had a prior grade >3 immune related adverse event due to anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA4 therapy at any time\n* Diagnosis of immunodeficiency or receipt of systemic steroid therapy or any other form of immunosuppressive therapy within 7 days before the first dose of trial treatment. Replacement therapy (ie physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic immunosuppressive therapy and is allowed.\n* History of gastrointestinal perforation or fistulae\n* A known history of active Bacillus tuberculosis\n* Known active central nervous system metastases and/or carcinomatous meningitis\n* History of or any evidence of active, non-infectious, immune-mediated pneumonitis. Patients with radiation-induced pneumonitis who are asymptomatic are permitted on study.\n* Peripheral neuropathy limiting ADLs\n* A known history of human immunodeficiency virus (HIV 1/2 antibodies)\n* Known active hepatitis B (e.g., HBsAg reactive) or hepatitis C (e.g., HCV RNA [qualitative] is detected). Patients with HBsAg reactive on entecavir may be eligible after consultation with hepatologist and study team.\n* Received a live vaccine within 30 days of planned start of study therapy\n* Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial\n* Pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with the prescreening or screening visit through 5 months after the last dose of trial treatment\n* Unwilling to give written, informed consent, unwilling to participate, or unable to comply with the protocol for the duration of the study",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Metastatic or advanced unresectable adenocarcinoma of esophageal, gastric, or gastroesophageal junction",
            "criterions": [
                {
                    "exact_snippets": "Metastatic or advanced unresectable adenocarcinoma",
                    "criterion": "adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "metastatic",
                                "advanced unresectable"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "adenocarcinoma of esophageal",
                    "criterion": "adenocarcinoma location",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "esophageal"
                        }
                    ]
                },
                {
                    "exact_snippets": "adenocarcinoma of ... gastric",
                    "criterion": "adenocarcinoma location",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "gastric"
                        }
                    ]
                },
                {
                    "exact_snippets": "adenocarcinoma of ... gastroesophageal junction",
                    "criterion": "adenocarcinoma location",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "gastroesophageal junction"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Disease progression on one prior line of therapy for metastatic disease. Patients with previously untreated advanced unresectable or metastatic disease may be included if disease progressed or recurred during neoadjuvant or adjuvant therapy or within 6 months of completion of those treatments.",
            "criterions": [
                {
                    "exact_snippets": "Disease progression on one prior line of therapy for metastatic disease.",
                    "criterion": "disease progression",
                    "requirements": [
                        {
                            "requirement_type": "prior line of therapy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients with previously untreated advanced unresectable or metastatic disease may be included if disease progressed or recurred during neoadjuvant or adjuvant therapy or within 6 months of completion of those treatments.",
                    "criterion": "previously untreated advanced unresectable or metastatic disease",
                    "requirements": [
                        {
                            "requirement_type": "progression or recurrence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time since completion of neoadjuvant or adjuvant therapy",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must have histologically or cytologically confirmed esophageal, gastric, or gastroesophageal junction adenocarcinoma",
            "criterions": [
                {
                    "exact_snippets": "histologically or cytologically confirmed esophageal, gastric, or gastroesophageal junction adenocarcinoma",
                    "criterion": "adenocarcinoma type",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        },
                        {
                            "requirement_type": "location",
                            "expected_value": [
                                "esophageal",
                                "gastric",
                                "gastroesophageal junction"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must have measurable or evaluable disease as defined by RECIST v1.1 criteria. Patients with evaluable disease must be eligible to begin with an induction cycle",
            "criterions": [
                {
                    "exact_snippets": "measurable or evaluable disease as defined by RECIST v1.1 criteria",
                    "criterion": "disease status",
                    "requirements": [
                        {
                            "requirement_type": "measurement",
                            "expected_value": [
                                "measurable",
                                "evaluable"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "evaluable disease must be eligible to begin with an induction cycle",
                    "criterion": "induction cycle eligibility",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Age 18 years or older",
            "criterions": [
                {
                    "exact_snippets": "Age 18 years or older",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ECOG performance status 0 to 1",
            "criterions": [
                {
                    "exact_snippets": "ECOG performance status 0 to 1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate organ function as defined in Table 2",
            "criterions": [
                {
                    "exact_snippets": "Adequate organ function",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": "as defined in Table 2"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Table 2. Organ function requirements for eligibility Hematological Absolute neutrophil count: ≥1000/mcL Platelets: ≥90,000/mcL Hemoglobin: ≥8 g/dL Renal Serum creatinine: ≤1.5X ULN Hepatic Serum total bilirubin: ≤1.5X ULN OR Direct bilirubin ≤ULN for subjects with total bilirubin levels >1.5X ULN, except patients with Gilbert's disease (≤3X ULN) AST and ALT: ≤2.5X ULN Albumin: ≥3 mg/dL",
            "criterions": [
                {
                    "exact_snippets": "Absolute neutrophil count: ≥1000/mcL",
                    "criterion": "absolute neutrophil count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1000,
                                "unit": "mcL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Platelets: ≥90,000/mcL",
                    "criterion": "platelets",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 90000,
                                "unit": "mcL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Hemoglobin: ≥8 g/dL",
                    "criterion": "hemoglobin",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 8,
                                "unit": "g/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Serum creatinine: ≤1.5X ULN",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "X ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Serum total bilirubin: ≤1.5X ULN",
                    "criterion": "serum total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "X ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Direct bilirubin ≤ULN for subjects with total bilirubin levels >1.5X ULN",
                    "criterion": "direct bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "except patients with Gilbert's disease (≤3X ULN)",
                    "criterion": "direct bilirubin in patients with Gilbert's disease",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "X ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "AST and ALT: ≤2.5X ULN",
                    "criterion": "AST and ALT",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "X ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Albumin: ≥3 mg/dL",
                    "criterion": "albumin",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Received prior therapy with ramucirumab at any time",
            "criterions": [
                {
                    "exact_snippets": "Received prior therapy with ramucirumab",
                    "criterion": "prior therapy with ramucirumab",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Received paclitaxel or docetaxel-based therapy within 6 month of study enrollment",
            "criterions": [
                {
                    "exact_snippets": "Received paclitaxel or docetaxel-based therapy within 6 month of study enrollment",
                    "criterion": "paclitaxel or docetaxel-based therapy",
                    "requirements": [
                        {
                            "requirement_type": "recency",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "month"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Had a prior grade >3 immune related adverse event due to anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA4 therapy at any time",
            "criterions": [
                {
                    "exact_snippets": "prior grade >3 immune related adverse event",
                    "criterion": "immune related adverse event",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "due to anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA4 therapy",
                    "criterion": "therapy type",
                    "requirements": [
                        {
                            "requirement_type": "causation",
                            "expected_value": [
                                "anti-PD-1",
                                "anti-PD-L1",
                                "anti-PD-L2",
                                "anti-CTLA4"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Diagnosis of immunodeficiency or receipt of systemic steroid therapy or any other form of immunosuppressive therapy within 7 days before the first dose of trial treatment. Replacement therapy (ie physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic immunosuppressive therapy and is allowed.",
            "criterions": [
                {
                    "exact_snippets": "Diagnosis of immunodeficiency",
                    "criterion": "immunodeficiency",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "receipt of systemic steroid therapy",
                    "criterion": "systemic steroid therapy",
                    "requirements": [
                        {
                            "requirement_type": "receipt",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "any other form of immunosuppressive therapy",
                    "criterion": "immunosuppressive therapy",
                    "requirements": [
                        {
                            "requirement_type": "receipt",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of gastrointestinal perforation or fistulae",
            "criterions": [
                {
                    "exact_snippets": "History of gastrointestinal perforation",
                    "criterion": "gastrointestinal perforation",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of ... fistulae",
                    "criterion": "fistulae",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* A known history of active Bacillus tuberculosis",
            "criterions": [
                {
                    "exact_snippets": "A known history of active Bacillus tuberculosis",
                    "criterion": "Bacillus tuberculosis",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": "active"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known active central nervous system metastases and/or carcinomatous meningitis",
            "criterions": [
                {
                    "exact_snippets": "Known active central nervous system metastases",
                    "criterion": "central nervous system metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    ]
                },
                {
                    "exact_snippets": "carcinomatous meningitis",
                    "criterion": "carcinomatous meningitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of or any evidence of active, non-infectious, immune-mediated pneumonitis. Patients with radiation-induced pneumonitis who are asymptomatic are permitted on study.",
            "criterions": [
                {
                    "exact_snippets": "History of or any evidence of active, non-infectious, immune-mediated pneumonitis.",
                    "criterion": "immune-mediated pneumonitis",
                    "requirements": [
                        {
                            "requirement_type": "history or evidence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "radiation-induced pneumonitis who are asymptomatic",
                    "criterion": "radiation-induced pneumonitis",
                    "requirements": [
                        {
                            "requirement_type": "symptoms",
                            "expected_value": "asymptomatic"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Peripheral neuropathy limiting ADLs",
            "criterions": [
                {
                    "exact_snippets": "Peripheral neuropathy limiting ADLs",
                    "criterion": "peripheral neuropathy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "limiting ADLs"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* A known history of human immunodeficiency virus (HIV 1/2 antibodies)",
            "criterions": [
                {
                    "exact_snippets": "A known history of human immunodeficiency virus (HIV 1/2 antibodies)",
                    "criterion": "human immunodeficiency virus (HIV 1/2 antibodies)",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known active hepatitis B (e.g., HBsAg reactive) or hepatitis C (e.g., HCV RNA [qualitative] is detected). Patients with HBsAg reactive on entecavir may be eligible after consultation with hepatologist and study team.",
            "criterions": [
                {
                    "exact_snippets": "Known active hepatitis B (e.g., HBsAg reactive)",
                    "criterion": "active hepatitis B",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hepatitis C (e.g., HCV RNA [qualitative] is detected)",
                    "criterion": "hepatitis C",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Received a live vaccine within 30 days of planned start of study therapy",
            "criterions": [
                {
                    "exact_snippets": "Received a live vaccine within 30 days of planned start of study therapy",
                    "criterion": "live vaccine",
                    "requirements": [
                        {
                            "requirement_type": "time since administration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial",
            "criterions": [
                {
                    "exact_snippets": "Known psychiatric or substance abuse disorders",
                    "criterion": "psychiatric disorders",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Known psychiatric or substance abuse disorders",
                    "criterion": "substance abuse disorders",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with the prescreening or screening visit through 5 months after the last dose of trial treatment",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breastfeeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "expecting to conceive",
                    "criterion": "expecting to conceive",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "father children",
                    "criterion": "expecting to father children",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Unwilling to give written, informed consent, unwilling to participate, or unable to comply with the protocol for the duration of the study",
            "criterions": [
                {
                    "exact_snippets": "Unwilling to give written, informed consent",
                    "criterion": "written, informed consent",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "unwilling to participate",
                    "criterion": "participation",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "unable to comply with the protocol for the duration of the study",
                    "criterion": "protocol compliance",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}