A First-in-human Study Using BDC-1001 as a Single Agent and in Combination With Nivolumab in Advanced HER2-Expressing Solid Tumors

[
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/statusVerifiedDate",
    "value": "2021-04"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2021-04-13"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2021-04-19"
  },
  {
    "op": "replace",
    "path": "/protocolSection/conditionsModule/conditions/0",
    "value": "HER2 Positive Solid Tumors"
  },
  {
    "op": "remove",
    "path": "/protocolSection/conditionsModule/conditions/1"
  },
  {
    "op": "remove",
    "path": "/protocolSection/conditionsModule/conditions/1"
  },
  {
    "op": "add",
    "path": "/protocolSection/conditionsModule/keywords",
    "value": [
      "HER2",
      "ERBB2",
      "Immunotherapy",
      "Gastric Cancer",
      "Gastroesophageal junction",
      "Breast Cancer",
      "Stomach Cancer",
      "Colorectal Cancer",
      "Gastrointestinal Cancer",
      "Non-Small Cell Lung Cancer",
      "Biliary Tract Cancer",
      "Head and Neck Cancer",
      "Urothelial Cancer",
      "Endometrial Cancer",
      "TLR7/8 agonist"
    ]
  },
  {
    "op": "replace",
    "path": "/protocolSection/designModule/enrollmentInfo/count",
    "value": 607
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/primaryOutcomes/1/timeFrame",
    "value": "up to 21 days"
  },
  {
    "op": "replace",
    "path": "/protocolSection/eligibilityModule/eligibilityCriteria",
    "value": "<p>Key Inclusion Criteria:</p><ul><li>Patient must have an advanced solid tumor with documented HER2-protein expression or gene amplification for which approved therapies have been exhausted or are not clinically indicated.</li><li>Measurable disease as determined by RECIST v.1.1.</li><li>Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.</li><li>Tumor tissue (archival or collected prior to the study start) available for exploratory biomarker evaluation.</li></ul><p>Key Exclusion Criteria:</p><ul><li>History of severe hypersensitivity to any ingredient of the study drug(s), including trastuzumab or other monoclonal antibody.</li><li>Previous treatment with a TLR 7, TLR 8 or a TLR 7&#x2F;8 agonist.</li><li>Impaired cardiac function or history of clinically significant cardiac disease</li><li>Human Immunodeficiency virus (HIV) infection, active hepatitis B infection, or hepatitis C infection.</li><li>Active SARS-CoV-2 infection</li><li>Untreated central nervous system (CNS), epidural tumor or metastasis, or brain metastasis.</li></ul><p>Other protocol defined inclusion&#x2F;exclusion criteria may apply.</p>"
  },
  {
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    "path": "/protocolSection/contactsLocationsModule/locations/8"
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  {
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    "path": "/protocolSection/contactsLocationsModule/locations/11",
    "value": {
      "zip": "05505",
      "city": "Seoul",
      "state": "Songpa-gu",
      "status": "RECRUITING",
      "country": "South Korea",
      "contacts": [
        {
          "name": "Yoon-Koo Kang",
          "role": "CONTACT",
          "email": "ykkang@amc.seoul.kr",
          "phone": "+82-2-3010-3230"
        }
      ],
      "facility": "Asan Medical Center",
      "geoPoint": {
        "lat": 37.566,
        "lon": 126.9784
      }
    }
  }
]