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NCT04278144

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

Version 22 to 23 · Bolt Biotherapeutics, Inc.

Patch inspector

Version 22 to 23

15 operations 4 path groups ctgov_internal_history
ClinicalTrials.gov
Severity is deterministic uncalibrated triage metadata, not validated review priority. Operation-level severity is inferred from deterministic path rules. Rule matches shown per operation are approximate previews (they skip the pipeline's suppression passes); the authoritative classification is the stored event record.
Plain-language summary

Manual review pending.

Rules fired
arms_or_interventions_changesecondary_outcome_any_change
Value signals

None recorded.

Provenance
Source
ctgov_internal_history
Fetched
2026-06-18 19:11:07+00
Raw hash
f99684731e7f00b3495cb8ff1b64e319c8536f86192e7c30f84e4f89cac2737d
Payload
Source URL
Design Trial model, phase, allocation, masking, arms, or interventions. Triage: High 2 ops
replace /protocolSection/armsInterventionsModule/armGroups/0/description
Triage: High
Arm Intervention Change Operation 4
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Escalating doses followed by expansion targeting breast and non-breast HER2 advanced malignancies
After
Escalating doses followed by expansion targeting HER2-expressing advanced malignancies
replace /protocolSection/armsInterventionsModule/armGroups/1/description
Triage: High
Arm Intervention Change Operation 5
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Escalating doses followed by expansion targeting breast and non-breast HER2 advanced malignancies
After
Escalating doses followed by expansion targeting HER2-expressing advanced malignancies
Secondary outcomes Additional endpoints and outcome descriptions. Triage: High 7 ops
replace /protocolSection/outcomesModule/secondaryOutcomes/0/measure
Triage: High
Secondary Outcome Change Operation 6
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
PK (Cmax) of BDC-1001 as a single agent and in combination with nivolumab
After
PK (Cmax) of BDC-1001
replace /protocolSection/outcomesModule/secondaryOutcomes/1/measure
Triage: High
Secondary Outcome Change Operation 7
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
PK (Cmin) of BDC-1001 as a single agent and in combination with nivolumab
After
PK (Cmin) of BDC-1001
replace /protocolSection/outcomesModule/secondaryOutcomes/2/measure
Triage: High
Secondary Outcome Change Operation 8
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
PK (AUC0-t) of BDC-1001 as a single agent and in combination with nivolumab
After
PK (AUC0-t) of BDC-1001
replace /protocolSection/outcomesModule/secondaryOutcomes/3/measure
Triage: High
Secondary Outcome Change Operation 9
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
PK (AUC0-inf) of BDC-1001 as a single agent and in combination with nivolumab
After
PK (AUC0-inf) of BDC-1001
replace /protocolSection/outcomesModule/secondaryOutcomes/4/measure
Triage: High
Secondary Outcome Change Operation 10
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
PK (CL) of BDC-1001 as a single agent and in combination with nivolumab
After
PK (CL) of BDC-1001
replace /protocolSection/outcomesModule/secondaryOutcomes/5/measure
Triage: High
Secondary Outcome Change Operation 11
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
PK (Vz) of BDC-1001 as a single agent and in combination with nivolumab
After
PK (Vz) of BDC-1001
replace /protocolSection/outcomesModule/secondaryOutcomes/6/measure
Triage: High
Secondary Outcome Change Operation 12
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
PK (t1/2) of BDC-1001 as a single agent and in combination with nivolumab
After
PK (t1/2) of BDC-1001
Contacts and locations Site, contact, and location updates that are usually operational. Triage: Uncategorized 3 ops
replace /protocolSection/contactsLocationsModule/locations/6/contacts/0/name
Triage: Uncategorized
Uncategorized Operation 13
Before
Kathy Estkowski
After
Katie L Robinson, BSN, RN, OCN
replace /protocolSection/contactsLocationsModule/locations/6/contacts/0/email
Triage: Uncategorized
Uncategorized Operation 14
Before
kathy.estkowski@startmidwest.com
After
katie.robinson@startmidwest.com
add /protocolSection/contactsLocationsModule/locations/10
Triage: Uncategorized
Uncategorized Operation 15
After
{
  "zip": "28204",
  "city": "Charlotte",
  "state": "North Carolina",
  "status": "RECRUITING",
  "country": "United States",
  "contacts": [
    {
      "name": "Carrie Chiluck, BSN, RN, OCN",
      "role": "CONTACT",
      "email": "carrie.chiluck@atriumhealth.org"
    }
  ],
  "facility": "Levine Cancer Institute",
  "geoPoint": {
    "lat": 35.22709,
    "lon": -80.84313
  }
}
Other registry fields Changes outside the current high-signal rule families. Triage: Uncategorized 3 ops
replace /protocolSection/statusModule/statusVerifiedDate
Triage: Uncategorized
Uncategorized Operation 1
Before
2021-12
After
2022-01
replace /protocolSection/statusModule/lastUpdateSubmitDate
Triage: Uncategorized
Uncategorized Operation 2
Before
2021-12-20
After
2022-01-14
replace /protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Uncategorized
Uncategorized Operation 3
Before
2021-12-21
After
2022-01-28
Raw JSON Patch 
[
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/statusVerifiedDate",
    "value": "2022-01"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2022-01-14"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2022-01-28"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/0/description",
    "value": "Escalating doses followed by expansion targeting HER2-expressing advanced malignancies"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/1/description",
    "value": "Escalating doses followed by expansion targeting HER2-expressing advanced malignancies"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/0/measure",
    "value": "PK (Cmax) of BDC-1001"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/1/measure",
    "value": "PK (Cmin) of BDC-1001"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/2/measure",
    "value": "PK (AUC0-t) of BDC-1001"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/3/measure",
    "value": "PK (AUC0-inf) of BDC-1001"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/4/measure",
    "value": "PK (CL) of BDC-1001"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/5/measure",
    "value": "PK (Vz) of BDC-1001"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/6/measure",
    "value": "PK (t1/2) of BDC-1001"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/6/contacts/0/name",
    "value": "Katie L Robinson, BSN, RN, OCN"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/6/contacts/0/email",
    "value": "katie.robinson@startmidwest.com"
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/10",
    "value": {
      "zip": "28204",
      "city": "Charlotte",
      "state": "North Carolina",
      "status": "RECRUITING",
      "country": "United States",
      "contacts": [
        {
          "name": "Carrie Chiluck, BSN, RN, OCN",
          "role": "CONTACT",
          "email": "carrie.chiluck@atriumhealth.org"
        }
      ],
      "facility": "Levine Cancer Institute",
      "geoPoint": {
        "lat": 35.22709,
        "lon": -80.84313
      }
    }
  }
]