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/identificationModule/briefTitle",
    "value": "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/identificationModule/officialTitle",
    "value": "Phase 1/2 Study of BDC-1001 as a Single Agent and in Combination With Nivolumab in Patients With Advanced HER2-Expressing Solid Tumors"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/statusVerifiedDate",
    "value": "2021-11"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2021-11-05"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2021-11-11"
  },
  {
    "op": "add",
    "path": "/protocolSection/sponsorCollaboratorsModule/collaborators",
    "value": [
      {
        "name": "Bristol-Myers Squibb",
        "class": "INDUSTRY"
      }
    ]
  },
  {
    "op": "replace",
    "path": "/protocolSection/descriptionModule/briefSummary",
    "value": "A first-in-human study using BDC-1001 as a single agent and in combination with nivolumab in HER2 expressing advanced malignancies"
  },
  {
    "op": "replace",
    "path": "/protocolSection/descriptionModule/detailedDescription",
    "value": "This study has four parts.\nPart 1 is a dose escalation of BDC-1001 as a single agent to determine the maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D), or maximum protocol dose (MPD) recommended for Part 3. In Part 3, the selected dose will be administered as monotherapy to patients with selected advanced malignancies.\nPart 2 is a dose escalation of BDC-1001 in combination with nivolumab to determine the maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D), or maximum protocol dose (MPD) recommended for Part 4. In Part 4, the selected dose will be administered in combination with nivolumab to patients with selected advanced malignancies."
  },
  {
    "op": "replace",
    "path": "/protocolSection/designModule/designInfo/interventionModelDescription",
    "value": "Multiple ascending dose and dose-expansion of BDC-1001 administered as a single agent or in combination with nivolumab."
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/1/label",
    "value": "Combination BDC-1001 plus nivolumab"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/1/interventionNames/1",
    "value": "Drug: Nivolumab"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/0",
    "value": "Combination BDC-1001 plus nivolumab"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/interventions/1/name",
    "value": "Nivolumab"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/interventions/1/armGroupLabels/0",
    "value": "Combination BDC-1001 plus nivolumab"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/interventions/1/otherNames/0",
    "value": "Opdivo"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/primaryOutcomes/0/description",
    "value": "Escalation period"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/primaryOutcomes/1/description",
    "value": "Escalation period"
  },
  {
    "op": "replace",
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    "value": "Escalation period"
  },
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    "op": "replace",
    "path": "/protocolSection/outcomesModule/primaryOutcomes/3/description",
    "value": "Escalation period"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/primaryOutcomes/4/measure",
    "value": "Objective response rate (ORR) of confirmed complete or partial responses (CR, PR)"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/primaryOutcomes/4/description",
    "value": "Expansion period"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/0/measure",
    "value": "PK (Cmax) of BDC-1001 as a single agent and in combination with nivolumab"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/1/measure",
    "value": "PK (Cmin) of BDC-1001 as a single agent and in combination with nivolumab"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/2/measure",
    "value": "PK (AUC0-t) of BDC-1001 as a single agent and in combination with nivolumab"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/2/description",
    "value": "Escalation period"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/3/measure",
    "value": "PK (AUC0-inf) of BDC-1001 as a single agent and in combination with nivolumab"
  },
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    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/3/description",
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  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/4/measure",
    "value": "PK (CL) of BDC-1001 as a single agent and in combination with nivolumab"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/4/description",
    "value": "Escalation period"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/5/measure",
    "value": "PK (Vz) of BDC-1001 as a single agent and in combination with nivolumab"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/5/description",
    "value": "Escalation period"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/6/measure",
    "value": "PK (t1/2) of BDC-1001 as a single agent and in combination with nivolumab"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/6/description",
    "value": "Escalation period"
  },
  {
    "op": "add",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/7",
    "value": {
      "measure": "Objective response rate (ORR) using RECIST 1.1",
      "timeFrame": "2 years",
      "description": "Escalation period"
    }
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/11/measure",
    "value": "Incidence of anti-BDC-1001 antibodies"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/12/measure",
    "value": "Incidence of adverse events (AEs) and serious adverse events (SAEs)"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/12/description",
    "value": "Expansion period"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/13/measure",
    "value": "Incidence of potential-immune related toxicities"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/13/description",
    "value": "Expansion period"
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/0",
    "value": {
      "zip": "85711",
      "city": "Tucson",
      "state": "Arizona",
      "status": "RECRUITING",
      "country": "United States",
      "contacts": [
        {
          "name": "Stacey Kimbell, RN",
          "role": "CONTACT",
          "email": "stacey.kimbell@usoncology.com",
          "phone": "520-668-5678"
        }
      ],
      "facility": "Arizona Oncology",
      "geoPoint": {
        "lat": 32.22174,
        "lon": -110.92648
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    }
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