{
    "info": {
        "nct_id": "NCT05076591",
        "official_title": "A Phase 1, Open-Label, Multicenter, Dose Escalation Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of IMM2902 in Patients with HER2-Expressing Advanced Solid Tumors",
        "inclusion_criteria": "* Age ≥ 18 years\n* Weigh greater than 30 kg\n* life expectancy of at least 3 months\n* Phase 1a Histologically or cytologically confirmed HER2-expressing advanced solid malignancy, who have been treated with at least one regimen of prior systemic therapy, or who refuse systemic therapy, and for which there is no curative therapy available.\n* Phase 1b Histological Diagnsis There will be 5 cohorts:\n\nCohort 1: Histologically confirmed HER2 overexpression (HER2 IHC 3+ or HER2 IHC 2+/ISH-positive) locally advanced (unresectable) and/or metastatic breast cancer who have progression on or after at least 2 prior lines of anti-HER2 directed therapy with trastuzumab, pertuzumab, tucatinib, Fam-trastuzumab deruxtecan-nxki and T-DM1 or other anti-HER2 therapy.\n\nCohort 2: Histologically confirmed HER2-low (HER2 IHC 1+ or HER2 IHC 2+/ISH-negative and/or HER2 gene amplification in tumor specimen or in circulating tumor cells by ISH, NGS, or ctDNA-NGS) locally advanced (unresectable) and/or metastatic breast cancer who have progression after 2 or more lines of systemic therapy.\n\nCohort 3: Histologically confirmed HER2 overexpression (HER2 IHC 3+ or HER2 IHC 2+/ISH-positive) locally advanced (unresectable) and/or metastatic gastric/esophageal/gastroesophageal junction (GEJ) cancer who have progression on or after at least one prior therapy, including prior fluoropyrimidine + platinum and prior trastuzumab, and/or fam-trastuzumab deruxtecan-nxki or other prior anti-HER2 (including investigational) therapy.\n\nCohort 4: Histologically confirmed HER2-low (HER2 IHC 1+ or HER2 IHC 2+/ISH-negative and/or HER2 gene amplification in tumor specimen or in circulating tumor cells by ISH, NGS, or ctDNA-NGS) locally advanced (unresectable) and/or metastatic gastric/esophageal/gastroesophageal junction (GEJ) cancer who have progression after 2 or more lines of systemic therapy.\n\nCohort 5: Histologically confirmed HER2 overexpression (HER2 IHC 3+ or HER2 IHC 2+/ISH-positive) any other solid tumor types, including but not limited to colorectal cancer, non-small cell lung (NSCLC), ovarian cancers, that are not breast\n\n* Has at least non-irradiated evaluable disease (target or non-target lesions) per RECIST version 1.1.\n* Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.\n* Completion of prior chemotherapy systemic anticancer therapy at least 2 weeks prior to study entry.\n* Radiation therapy must be completed at least 2 weeks prior to study entry. Radiated lesions may not serve as measurable disease unless they have been radiated ≥12 months prior to enrollment.\n* Patients may have parenchymal brain metastases if stable (no evidence of progression) for at least 1 month after local therapy (radiation or surgery). Leptomeningeal disease is excluded.\n* Patients must have adequate organ and bone marrow function within 14 days of first dose of study drug administration\n* Female subject must either be of non-reproductive potential or must have a negative urine or serum prenancy test within 7 days prior to the first dose of IMM2902.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Prior anti-cancer therapy including chemotherapy, hormonal therapy, or investigational agents within 2 weeks or within at least 4 half-lives prior to IMM2902 dosing (up to a maximum of 4 weeks).\n* Prior treatment with neoadjuvant or adjuvant anthracyclines within cumulative dose of doxorubicin of >400 mg/m2 or epirubicin of >800 mg/m².\n* Prior treatment with CD47 or SIRPα-targeting agents.\n* Trastuzumab, pertuzumab, lapatinib, tucatinib, fam-trastuzumab deruxtecan-nxki or T-DM1 within 3 weeks before first IMM2902 dosing.\n* Any unresolved toxicity NCI CTCAE v5.0 Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria.\n* Mean QT interval corrected for heart rate (QTc) ≥ 450 ms for males or QTc ≥ 470 ms for females calculated from 2 electrocardiograms (ECGs) using Fridericia's formula. Two EKGs 5 minutes (+/-2 min) apart are mandatory.\n* Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]).\n* Symptomatic congestive heart failure New York Heart Association (NYHA) Function Classification II-IV, uncontrolled hypertension, acute myocardial infarction within the last 6 months, unstable angina pectoris, cardiac arrhythmia.\n* Uncontrolled diabetes mellitus, Interstitial lung disease, serious gastrointestinal conditions associated with diarrhea.\n* Pulmonary embolism or deep vein thrombosis within 3 months prior to the first dose of study drug.\n* Uncontrolled pulmonary, renal, or hepatic dysfunction.\n* Ongoing or active infection requiring systemic treatment.\n* Psychiatric illness/social situations that would limit compliance with study requirements, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent.\n* Any other illness or condition that the treating investigator feels would interfere with study compliance or would compromise the patient's safety or study endpoints.\n* Second malignancy, except treated basal cell or localized squamous skin carcinomas, localized prostate cancer, or other malignancy for which treatment was completed at least 3 years ago and for which there is no evidence of recurrence.\n* Known allergic reactions to any component or excipient of IMM2902 or known allergic reactions to trastuzumab or other prior anti-HER2 (including investigational) or other monoclonal antibody ≥ Grade 3.\n* Patients requiring concomitant therapeutic anticoagulation, excluding those taking low dose of anticoagulation agents for diseases such as pulmonary embolism, deep venous thrombosis.\n* Known active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus.\n* Known inherited or acquired bleeding disorders.\n* History of hemolytic anemia or Evans syndrome, sickle cell disease, thalassemia, G6PD deficiency, hereditary spherocytosis, or hypersplenism in the last 3 months.\n* Current or prior use of immunosuppressive therapy within 14 days before the first dose of IMM2902.\n* Receipt of live attenuated vaccination within 30 days prior to registration.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Age ≥ 18 years",
            "criterions": [
                {
                    "exact_snippets": "Age ≥ 18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Weigh greater than 30 kg",
            "criterions": [
                {
                    "exact_snippets": "Weigh greater than 30 kg",
                    "criterion": "weight",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 30,
                                "unit": "kg"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* life expectancy of at least 3 months",
            "criterions": [
                {
                    "exact_snippets": "life expectancy of at least 3 months",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Phase 1a Histologically or cytologically confirmed HER2-expressing advanced solid malignancy, who have been treated with at least one regimen of prior systemic therapy, or who refuse systemic therapy, and for which there is no curative therapy available.",
            "criterions": [
                {
                    "exact_snippets": "Histologically or cytologically confirmed HER2-expressing advanced solid malignancy",
                    "criterion": "HER2-expressing advanced solid malignancy",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "treated with at least one regimen of prior systemic therapy",
                    "criterion": "prior systemic therapy",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "regimen"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "refuse systemic therapy",
                    "criterion": "refusal of systemic therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "for which there is no curative therapy available",
                    "criterion": "curative therapy availability",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Phase 1b Histological Diagnsis There will be 5 cohorts:",
            "criterions": [
                {
                    "exact_snippets": "Phase 1b Histological Diagnsis",
                    "criterion": "histological diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "phase",
                            "expected_value": "1b"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Cohort 1: Histologically confirmed HER2 overexpression (HER2 IHC 3+ or HER2 IHC 2+/ISH-positive) locally advanced (unresectable) and/or metastatic breast cancer who have progression on or after at least 2 prior lines of anti-HER2 directed therapy with trastuzumab, pertuzumab, tucatinib, Fam-trastuzumab deruxtecan-nxki and T-DM1 or other anti-HER2 therapy.",
            "criterions": [
                {
                    "exact_snippets": "Histologically confirmed HER2 overexpression (HER2 IHC 3+ or HER2 IHC 2+/ISH-positive)",
                    "criterion": "HER2 overexpression",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "histologically confirmed"
                        },
                        {
                            "requirement_type": "expression level",
                            "expected_value": [
                                "HER2 IHC 3+",
                                "HER2 IHC 2+/ISH-positive"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "locally advanced (unresectable) and/or metastatic breast cancer",
                    "criterion": "breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "locally advanced (unresectable)",
                                "metastatic"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "progression on or after at least 2 prior lines of anti-HER2 directed therapy",
                    "criterion": "anti-HER2 therapy progression",
                    "requirements": [
                        {
                            "requirement_type": "progression",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "prior lines",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "lines"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "trastuzumab, pertuzumab, tucatinib, Fam-trastuzumab deruxtecan-nxki and T-DM1 or other anti-HER2 therapy",
                    "criterion": "anti-HER2 therapy",
                    "requirements": [
                        {
                            "requirement_type": "therapies",
                            "expected_value": [
                                "trastuzumab",
                                "pertuzumab",
                                "tucatinib",
                                "Fam-trastuzumab deruxtecan-nxki",
                                "T-DM1",
                                "other anti-HER2 therapy"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "Cohort 2: Histologically confirmed HER2-low (HER2 IHC 1+ or HER2 IHC 2+/ISH-negative and/or HER2 gene amplification in tumor specimen or in circulating tumor cells by ISH, NGS, or ctDNA-NGS) locally advanced (unresectable) and/or metastatic breast cancer who have progression after 2 or more lines of systemic therapy.",
            "criterions": [
                {
                    "exact_snippets": "Histologically confirmed HER2-low (HER2 IHC 1+ or HER2 IHC 2+/ISH-negative and/or HER2 gene amplification in tumor specimen or in circulating tumor cells by ISH, NGS, or ctDNA-NGS)",
                    "criterion": "HER2 status",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "HER2-low"
                        },
                        {
                            "requirement_type": "methods",
                            "expected_value": [
                                "IHC 1+",
                                "IHC 2+/ISH-negative",
                                "HER2 gene amplification in tumor specimen",
                                "HER2 gene amplification in circulating tumor cells by ISH",
                                "HER2 gene amplification in circulating tumor cells by NGS",
                                "HER2 gene amplification in circulating tumor cells by ctDNA-NGS"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "locally advanced (unresectable) and/or metastatic breast cancer",
                    "criterion": "breast cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "locally advanced (unresectable)",
                                "metastatic"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "progression after 2 or more lines of systemic therapy",
                    "criterion": "systemic therapy progression",
                    "requirements": [
                        {
                            "requirement_type": "progression",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "lines of therapy",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "lines"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Cohort 3: Histologically confirmed HER2 overexpression (HER2 IHC 3+ or HER2 IHC 2+/ISH-positive) locally advanced (unresectable) and/or metastatic gastric/esophageal/gastroesophageal junction (GEJ) cancer who have progression on or after at least one prior therapy, including prior fluoropyrimidine + platinum and prior trastuzumab, and/or fam-trastuzumab deruxtecan-nxki or other prior anti-HER2 (including investigational) therapy.",
            "criterions": [
                {
                    "exact_snippets": "Histologically confirmed HER2 overexpression (HER2 IHC 3+ or HER2 IHC 2+/ISH-positive)",
                    "criterion": "HER2 overexpression",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "histologically"
                        },
                        {
                            "requirement_type": "expression level",
                            "expected_value": [
                                "HER2 IHC 3+",
                                "HER2 IHC 2+/ISH-positive"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "locally advanced (unresectable) and/or metastatic gastric/esophageal/gastroesophageal junction (GEJ) cancer",
                    "criterion": "cancer type and stage",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "gastric",
                                "esophageal",
                                "gastroesophageal junction (GEJ)"
                            ]
                        },
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "locally advanced (unresectable)",
                                "metastatic"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "progression on or after at least one prior therapy",
                    "criterion": "progression after prior therapy",
                    "requirements": [
                        {
                            "requirement_type": "progression",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "including prior fluoropyrimidine + platinum and prior trastuzumab, and/or fam-trastuzumab deruxtecan-nxki or other prior anti-HER2 (including investigational) therapy",
                    "criterion": "prior therapies",
                    "requirements": [
                        {
                            "requirement_type": "therapies",
                            "expected_value": [
                                "fluoropyrimidine + platinum",
                                "trastuzumab",
                                "fam-trastuzumab deruxtecan-nxki",
                                "other prior anti-HER2 (including investigational) therapy"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "Cohort 4: Histologically confirmed HER2-low (HER2 IHC 1+ or HER2 IHC 2+/ISH-negative and/or HER2 gene amplification in tumor specimen or in circulating tumor cells by ISH, NGS, or ctDNA-NGS) locally advanced (unresectable) and/or metastatic gastric/esophageal/gastroesophageal junction (GEJ) cancer who have progression after 2 or more lines of systemic therapy.",
            "criterions": [
                {
                    "exact_snippets": "Histologically confirmed HER2-low (HER2 IHC 1+ or HER2 IHC 2+/ISH-negative and/or HER2 gene amplification in tumor specimen or in circulating tumor cells by ISH, NGS, or ctDNA-NGS)",
                    "criterion": "HER2 status",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically confirmed"
                        },
                        {
                            "requirement_type": "status",
                            "expected_value": "HER2-low"
                        },
                        {
                            "requirement_type": "IHC",
                            "expected_value": [
                                "1+",
                                "2+/ISH-negative"
                            ]
                        },
                        {
                            "requirement_type": "gene amplification",
                            "expected_value": "in tumor specimen or in circulating tumor cells by ISH, NGS, or ctDNA-NGS"
                        }
                    ]
                },
                {
                    "exact_snippets": "locally advanced (unresectable) and/or metastatic gastric/esophageal/gastroesophageal junction (GEJ) cancer",
                    "criterion": "cancer type and stage",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "gastric",
                                "esophageal",
                                "gastroesophageal junction (GEJ)"
                            ]
                        },
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "locally advanced (unresectable)",
                                "metastatic"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "progression after 2 or more lines of systemic therapy",
                    "criterion": "treatment history",
                    "requirements": [
                        {
                            "requirement_type": "progression",
                            "expected_value": "after 2 or more lines of systemic therapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Cohort 5: Histologically confirmed HER2 overexpression (HER2 IHC 3+ or HER2 IHC 2+/ISH-positive) any other solid tumor types, including but not limited to colorectal cancer, non-small cell lung (NSCLC), ovarian cancers, that are not breast",
            "criterions": [
                {
                    "exact_snippets": "Histologically confirmed HER2 overexpression (HER2 IHC 3+ or HER2 IHC 2+/ISH-positive)",
                    "criterion": "HER2 overexpression",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "histologically confirmed"
                        },
                        {
                            "requirement_type": "IHC score",
                            "expected_value": [
                                "3+",
                                "2+/ISH-positive"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "any other solid tumor types, including but not limited to colorectal cancer, non-small cell lung (NSCLC), ovarian cancers, that are not breast",
                    "criterion": "solid tumor type",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": "breast cancer"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has at least non-irradiated evaluable disease (target or non-target lesions) per RECIST version 1.1.",
            "criterions": [
                {
                    "exact_snippets": "non-irradiated evaluable disease",
                    "criterion": "evaluable disease",
                    "requirements": [
                        {
                            "requirement_type": "irradiation status",
                            "expected_value": "non-irradiated"
                        }
                    ]
                },
                {
                    "exact_snippets": "evaluable disease (target or non-target lesions) per RECIST version 1.1",
                    "criterion": "evaluable disease",
                    "requirements": [
                        {
                            "requirement_type": "evaluation criteria",
                            "expected_value": "RECIST version 1.1"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status of ≤2",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "performance status",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Completion of prior chemotherapy systemic anticancer therapy at least 2 weeks prior to study entry.",
            "criterions": [
                {
                    "exact_snippets": "Completion of prior chemotherapy systemic anticancer therapy at least 2 weeks prior to study entry.",
                    "criterion": "prior chemotherapy systemic anticancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time since completion",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Radiation therapy must be completed at least 2 weeks prior to study entry. Radiated lesions may not serve as measurable disease unless they have been radiated ≥12 months prior to enrollment.",
            "criterions": [
                {
                    "exact_snippets": "Radiation therapy must be completed at least 2 weeks prior to study entry.",
                    "criterion": "radiation therapy completion",
                    "requirements": [
                        {
                            "requirement_type": "time since completion",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Radiated lesions may not serve as measurable disease unless they have been radiated ≥12 months prior to enrollment.",
                    "criterion": "radiated lesions",
                    "requirements": [
                        {
                            "requirement_type": "time since radiation",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients may have parenchymal brain metastases if stable (no evidence of progression) for at least 1 month after local therapy (radiation or surgery). Leptomeningeal disease is excluded.",
            "criterions": [
                {
                    "exact_snippets": "parenchymal brain metastases if stable (no evidence of progression) for at least 1 month after local therapy (radiation or surgery)",
                    "criterion": "parenchymal brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": "stable (no evidence of progression)"
                        },
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "month"
                            }
                        },
                        {
                            "requirement_type": "post-therapy",
                            "expected_value": [
                                "radiation",
                                "surgery"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Leptomeningeal disease is excluded",
                    "criterion": "Leptomeningeal disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must have adequate organ and bone marrow function within 14 days of first dose of study drug administration",
            "criterions": [
                {
                    "exact_snippets": "adequate organ and bone marrow function",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "adequate organ and bone marrow function",
                    "criterion": "bone marrow function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Prior anti-cancer therapy including chemotherapy, hormonal therapy, or investigational agents within 2 weeks or within at least 4 half-lives prior to IMM2902 dosing (up to a maximum of 4 weeks).",
            "criterions": [
                {
                    "exact_snippets": "Prior anti-cancer therapy including chemotherapy, hormonal therapy, or investigational agents within 2 weeks or within at least 4 half-lives prior to IMM2902 dosing (up to a maximum of 4 weeks).",
                    "criterion": "prior anti-cancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "types",
                            "expected_value": [
                                "chemotherapy",
                                "hormonal therapy",
                                "investigational agents"
                            ]
                        },
                        {
                            "requirement_type": "time since last therapy",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "time since last therapy",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "time since last therapy",
                            "expected_value": "within at least 4 half-lives prior to IMM2902 dosing"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior treatment with neoadjuvant or adjuvant anthracyclines within cumulative dose of doxorubicin of >400 mg/m2 or epirubicin of >800 mg/m².",
            "criterions": [
                {
                    "exact_snippets": "Prior treatment with neoadjuvant or adjuvant anthracyclines",
                    "criterion": "prior treatment with anthracyclines",
                    "requirements": [
                        {
                            "requirement_type": "treatment type",
                            "expected_value": [
                                "neoadjuvant",
                                "adjuvant"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "cumulative dose of doxorubicin of >400 mg/m2",
                    "criterion": "cumulative dose of doxorubicin",
                    "requirements": [
                        {
                            "requirement_type": "dose",
                            "expected_value": {
                                "operator": ">",
                                "value": 400,
                                "unit": "mg/m2"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "cumulative dose ... epirubicin of >800 mg/m²",
                    "criterion": "cumulative dose of epirubicin",
                    "requirements": [
                        {
                            "requirement_type": "dose",
                            "expected_value": {
                                "operator": ">",
                                "value": 800,
                                "unit": "mg/m²"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior treatment with CD47 or SIRPα-targeting agents.",
            "criterions": [
                {
                    "exact_snippets": "Prior treatment with CD47",
                    "criterion": "CD47-targeting agents",
                    "requirements": [
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior treatment with ... SIRPα-targeting agents",
                    "criterion": "SIRPα-targeting agents",
                    "requirements": [
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Trastuzumab, pertuzumab, lapatinib, tucatinib, fam-trastuzumab deruxtecan-nxki or T-DM1 within 3 weeks before first IMM2902 dosing.",
            "criterions": [
                {
                    "exact_snippets": "Trastuzumab, pertuzumab, lapatinib, tucatinib, fam-trastuzumab deruxtecan-nxki or T-DM1 within 3 weeks before first IMM2902 dosing.",
                    "criterion": "use of specific drugs",
                    "requirements": [
                        {
                            "requirement_type": "drugs",
                            "expected_value": [
                                "Trastuzumab",
                                "pertuzumab",
                                "lapatinib",
                                "tucatinib",
                                "fam-trastuzumab deruxtecan-nxki",
                                "T-DM1"
                            ]
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any unresolved toxicity NCI CTCAE v5.0 Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria.",
            "criterions": [
                {
                    "exact_snippets": "unresolved toxicity NCI CTCAE v5.0 Grade ≥2 from previous anticancer therapy",
                    "criterion": "unresolved toxicity from previous anticancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "NCI CTCAE v5.0 Grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Mean QT interval corrected for heart rate (QTc) ≥ 450 ms for males or QTc ≥ 470 ms for females calculated from 2 electrocardiograms (ECGs) using Fridericia's formula. Two EKGs 5 minutes (+/-2 min) apart are mandatory.",
            "criterions": [
                {
                    "exact_snippets": "Mean QT interval corrected for heart rate (QTc) ≥ 450 ms for males",
                    "criterion": "QTc interval for males",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 450,
                                "unit": "ms"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "QTc ≥ 470 ms for females",
                    "criterion": "QTc interval for females",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 470,
                                "unit": "ms"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "calculated from 2 electrocardiograms (ECGs) using Fridericia's formula",
                    "criterion": "QTc calculation method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": "Fridericia's formula"
                        }
                    ]
                },
                {
                    "exact_snippets": "Two EKGs 5 minutes (+/-2 min) apart are mandatory",
                    "criterion": "EKG timing",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "5 minutes (+/-2 min) apart"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]).",
            "criterions": [
                {
                    "exact_snippets": "Active or prior documented autoimmune or inflammatory disorders",
                    "criterion": "autoimmune or inflammatory disorders",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "inflammatory bowel disease [eg, colitis or Crohn's disease]",
                    "criterion": "inflammatory bowel disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "diverticulitis [with the exception of diverticulosis]",
                    "criterion": "diverticulitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "systemic lupus erythematosus",
                    "criterion": "systemic lupus erythematosus",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Sarcoidosis syndrome",
                    "criterion": "Sarcoidosis syndrome",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Wegener syndrome [granulomatosis with polyangiitis",
                    "criterion": "Wegener syndrome (granulomatosis with polyangiitis)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Graves' disease",
                    "criterion": "Graves' disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "rheumatoid arthritis",
                    "criterion": "rheumatoid arthritis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hypophysitis",
                    "criterion": "hypophysitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "uveitis",
                    "criterion": "uveitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Symptomatic congestive heart failure New York Heart Association (NYHA) Function Classification II-IV, uncontrolled hypertension, acute myocardial infarction within the last 6 months, unstable angina pectoris, cardiac arrhythmia.",
            "criterions": [
                {
                    "exact_snippets": "Symptomatic congestive heart failure New York Heart Association (NYHA) Function Classification II-IV",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "symptomatic",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "NYHA classification",
                            "expected_value": [
                                "II",
                                "III",
                                "IV"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled hypertension",
                    "criterion": "hypertension",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "acute myocardial infarction within the last 6 months",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "recency",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "unstable angina pectoris",
                    "criterion": "angina pectoris",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": "unstable"
                        }
                    ]
                },
                {
                    "exact_snippets": "cardiac arrhythmia",
                    "criterion": "cardiac arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Uncontrolled diabetes mellitus, Interstitial lung disease, serious gastrointestinal conditions associated with diarrhea.",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled diabetes mellitus",
                    "criterion": "diabetes mellitus",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "Interstitial lung disease",
                    "criterion": "interstitial lung disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "serious gastrointestinal conditions associated with diarrhea",
                    "criterion": "gastrointestinal conditions",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        },
                        {
                            "requirement_type": "association",
                            "expected_value": "diarrhea"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pulmonary embolism or deep vein thrombosis within 3 months prior to the first dose of study drug.",
            "criterions": [
                {
                    "exact_snippets": "Pulmonary embolism ... within 3 months prior to the first dose of study drug.",
                    "criterion": "pulmonary embolism",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "deep vein thrombosis within 3 months prior to the first dose of study drug.",
                    "criterion": "deep vein thrombosis",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Uncontrolled pulmonary, renal, or hepatic dysfunction.",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled pulmonary ... dysfunction.",
                    "criterion": "pulmonary dysfunction",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrolled ... renal ... dysfunction.",
                    "criterion": "renal dysfunction",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrolled ... hepatic dysfunction.",
                    "criterion": "hepatic dysfunction",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Ongoing or active infection requiring systemic treatment.",
            "criterions": [
                {
                    "exact_snippets": "Ongoing or active infection requiring systemic treatment.",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "ongoing",
                                "active"
                            ]
                        },
                        {
                            "requirement_type": "treatment",
                            "expected_value": "systemic"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Psychiatric illness/social situations that would limit compliance with study requirements, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent.",
            "criterions": [
                {
                    "exact_snippets": "Psychiatric illness",
                    "criterion": "psychiatric illness",
                    "requirements": [
                        {
                            "requirement_type": "impact on compliance",
                            "expected_value": "limit compliance with study requirements"
                        },
                        {
                            "requirement_type": "risk",
                            "expected_value": "substantially increase risk of incurring AEs"
                        },
                        {
                            "requirement_type": "consent ability",
                            "expected_value": "compromise the ability of the patient to give written informed consent"
                        }
                    ]
                },
                {
                    "exact_snippets": "social situations",
                    "criterion": "social situations",
                    "requirements": [
                        {
                            "requirement_type": "impact on compliance",
                            "expected_value": "limit compliance with study requirements"
                        },
                        {
                            "requirement_type": "risk",
                            "expected_value": "substantially increase risk of incurring AEs"
                        },
                        {
                            "requirement_type": "consent ability",
                            "expected_value": "compromise the ability of the patient to give written informed consent"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any other illness or condition that the treating investigator feels would interfere with study compliance or would compromise the patient's safety or study endpoints.",
            "criterions": [
                {
                    "exact_snippets": "Any other illness or condition",
                    "criterion": "illness or condition",
                    "requirements": [
                        {
                            "requirement_type": "interference with study compliance",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "compromise patient safety",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "compromise study endpoints",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Second malignancy, except treated basal cell or localized squamous skin carcinomas, localized prostate cancer, or other malignancy for which treatment was completed at least 3 years ago and for which there is no evidence of recurrence.",
            "criterions": [
                {
                    "exact_snippets": "Second malignancy",
                    "criterion": "second malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "except treated basal cell or localized squamous skin carcinomas",
                    "criterion": "treated basal cell or localized squamous skin carcinomas",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "localized prostate cancer",
                    "criterion": "localized prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "other malignancy for which treatment was completed at least 3 years ago and for which there is no evidence of recurrence",
                    "criterion": "other malignancy",
                    "requirements": [
                        {
                            "requirement_type": "treatment completion time",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "years"
                            }
                        },
                        {
                            "requirement_type": "evidence of recurrence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known allergic reactions to any component or excipient of IMM2902 or known allergic reactions to trastuzumab or other prior anti-HER2 (including investigational) or other monoclonal antibody ≥ Grade 3.",
            "criterions": [
                {
                    "exact_snippets": "Known allergic reactions to any component or excipient of IMM2902",
                    "criterion": "allergic reactions to IMM2902 components",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "known allergic reactions to trastuzumab",
                    "criterion": "allergic reactions to trastuzumab",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "known allergic reactions to ... other prior anti-HER2 (including investigational)",
                    "criterion": "allergic reactions to prior anti-HER2",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "known allergic reactions to ... other monoclonal antibody ≥ Grade 3",
                    "criterion": "allergic reactions to other monoclonal antibodies",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "Grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients requiring concomitant therapeutic anticoagulation, excluding those taking low dose of anticoagulation agents for diseases such as pulmonary embolism, deep venous thrombosis.",
            "criterions": [
                {
                    "exact_snippets": "Patients requiring concomitant therapeutic anticoagulation",
                    "criterion": "therapeutic anticoagulation",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "excluding those taking low dose of anticoagulation agents",
                    "criterion": "low dose anticoagulation",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "for diseases such as pulmonary embolism, deep venous thrombosis",
                    "criterion": "diseases requiring low dose anticoagulation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "pulmonary embolism",
                                "deep venous thrombosis"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus.",
            "criterions": [
                {
                    "exact_snippets": "Known active infection including tuberculosis",
                    "criterion": "active infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hepatitis B",
                    "criterion": "hepatitis B",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hepatitis C",
                    "criterion": "hepatitis C",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "human immunodeficiency virus",
                    "criterion": "human immunodeficiency virus",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known inherited or acquired bleeding disorders.",
            "criterions": [
                {
                    "exact_snippets": "Known inherited or acquired bleeding disorders",
                    "criterion": "bleeding disorders",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "inheritance",
                            "expected_value": [
                                "inherited",
                                "acquired"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of hemolytic anemia or Evans syndrome, sickle cell disease, thalassemia, G6PD deficiency, hereditary spherocytosis, or hypersplenism in the last 3 months.",
            "criterions": [
                {
                    "exact_snippets": "History of hemolytic anemia",
                    "criterion": "hemolytic anemia",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Evans syndrome",
                    "criterion": "Evans syndrome",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "sickle cell disease",
                    "criterion": "sickle cell disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "thalassemia",
                    "criterion": "thalassemia",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "G6PD deficiency",
                    "criterion": "G6PD deficiency",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hereditary spherocytosis",
                    "criterion": "hereditary spherocytosis",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hypersplenism in the last 3 months",
                    "criterion": "hypersplenism",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": "last 3 months"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Current or prior use of immunosuppressive therapy within 14 days before the first dose of IMM2902.",
            "criterions": [
                {
                    "exact_snippets": "Current or prior use of immunosuppressive therapy within 14 days before the first dose of IMM2902.",
                    "criterion": "use of immunosuppressive therapy",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 14 days before the first dose of IMM2902"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Receipt of live attenuated vaccination within 30 days prior to registration.",
            "criterions": [
                {
                    "exact_snippets": "Receipt of live attenuated vaccination within 30 days prior to registration.",
                    "criterion": "live attenuated vaccination",
                    "requirements": [
                        {
                            "requirement_type": "receipt",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "* Female subject must either be of non-reproductive potential or must have a negative urine or serum prenancy test within 7 days prior to the first dose of IMM2902.",
            "criterions": [
                {
                    "exact_snippets": "Female subject must either be of non-reproductive potential",
                    "criterion": "reproductive potential",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "non-reproductive"
                        }
                    ]
                },
                {
                    "exact_snippets": "must have a negative urine or serum pregnancy test within 7 days prior to the first dose of IMM2902",
                    "criterion": "pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        },
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 7 days prior to the first dose of IMM2902"
                        }
                    ]
                }
            ]
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}