Back to trial

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 31 to 32 · Bolt Biotherapeutics, Inc.

Patch inspector

Version 31 to 32

15 operations 5 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
terminal_status_changewhy_stopped_change
Value signals
[
  {
    "path": "/protocolSection/statusModule/primaryCompletionDateStruct/date",
    "signal": "timeline_actualized_earlier",
    "category": "timeline_actualized_earlier",
    "new_type": "ACTUAL",
    "old_type": "ESTIMATED",
    "severity": "low",
    "direction": "earlier",
    "new_value": "2024-10-07",
    "old_value": "2025-01-31",
    "delta_days": 116,
    "date_struct": "primaryCompletionDateStruct",
    "new_precision": "day",
    "old_precision": "day"
  },
  {
    "path": "/protocolSection/statusModule/completionDateStruct/date",
    "signal": "timeline_actualized_earlier",
    "category": "timeline_actualized_earlier",
    "new_type": "ACTUAL",
    "old_type": "ESTIMATED",
    "severity": "low",
    "direction": "earlier",
    "new_value": "2025-02-14",
    "old_value": "2026-01-31",
    "delta_days": 351,
    "date_struct": "completionDateStruct",
    "new_precision": "day",
    "old_precision": "day"
  },
  {
    "path": "/protocolSection/statusModule/whyStopped",
    "value": "Sponsor Decision",
    "signal": "why_stopped_low_information",
    "category": "status_termination",
    "severity": "high"
  }
]
Provenance
Source
ctgov_internal_history
Fetched
2026-06-18 19:11:09+00
Raw hash
68f95ff92e1c5ac1a0de0178d8894586ba96752ddc2531e467003f6ca70ed3bf
Payload
Source URL
Status and stopping reason Recruitment status, termination, suspension, withdrawal, or why-stopped text. Triage: High 2 ops
replace /protocolSection/statusModule/overallStatus
Triage: High
Status Termination Operation 4
Matched rules
  • terminal_status_change Status changed to terminated, suspended, or withdrawn; whyStopped content determines whether critical review is warranted.
Before
ACTIVE_NOT_RECRUITING
After
TERMINATED
add /protocolSection/statusModule/whyStopped
Triage: High
Status Termination Operation 11
Matched rules
  • why_stopped_change Why-stopped changes explain discontinuation and need review.
After
Sponsor Decision
Timeline Start, primary completion, and completion date movement. Triage: Medium 4 ops
replace /protocolSection/statusModule/primaryCompletionDateStruct/date
Triage: Medium
Timeline Shift Operation 5
Matched rules
  • primary_completion_timeline_change Primary completion date changes are operational timeline signals.
Before
2025-01-31
After
2024-10-07
replace /protocolSection/statusModule/primaryCompletionDateStruct/type
Triage: Medium
Timeline Shift Operation 6
Matched rules
  • primary_completion_timeline_change Primary completion date changes are operational timeline signals.
Before
ESTIMATED
After
ACTUAL
replace /protocolSection/statusModule/completionDateStruct/date
Triage: Medium
Timeline Shift Operation 7
Matched rules
  • completion_timeline_change Completion date changes are operational timeline signals.
Before
2026-01-31
After
2025-02-14
replace /protocolSection/statusModule/completionDateStruct/type
Triage: Medium
Timeline Shift Operation 8
Matched rules
  • completion_timeline_change Completion date changes are operational timeline signals.
Before
ESTIMATED
After
ACTUAL
Contacts and locations Site, contact, and location updates that are usually operational. Triage: Uncategorized 2 ops
add /protocolSection/contactsLocationsModule/locations/19/state
Triage: Uncategorized
Uncategorized Operation 14
After
Madrid
add /protocolSection/contactsLocationsModule/locations/20/state
Triage: Uncategorized
Uncategorized Operation 15
After
Madrid
Other registry fields Changes outside the current high-signal rule families. Triage: Uncategorized 4 ops
replace /protocolSection/statusModule/statusVerifiedDate
Triage: Uncategorized
Uncategorized Operation 3
Before
2024-10
After
2025-02
replace /protocolSection/statusModule/lastUpdateSubmitDate
Triage: Uncategorized
Uncategorized Operation 9
Before
2024-10-07
After
2025-02-20
replace /protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Uncategorized
Uncategorized Operation 10
Before
2024-10-09
After
2025-02-24
add /protocolSection/statusModule/expandedAccessInfo
Triage: Uncategorized
Uncategorized Operation 12
After
{
  "hasExpandedAccess": false
}
Sponsor and administrative fields Sponsor, collaborator, oversight, or registry maintenance changes. Triage: Uncategorized 3 ops
replace /protocolSection/identificationModule/briefTitle
Triage: Uncategorized
Uncategorized Operation 1
Before
A First-in-human Study Using BDC-1001 as a Single Agent and in Combination With Nivolumab in Advanced HER2-Expressing Solid Tumors
After
A First-in-human Study Using BDC-1001 As a Single Agent and in Combination with Nivolumab in Advanced HER2-Expressing Solid Tumors
replace /protocolSection/identificationModule/officialTitle
Triage: Uncategorized
Uncategorized Operation 2
Before
Phase 1/2 Study of BDC-1001 as a Single Agent and in Combination With Nivolumab in Patients With Advanced HER2-Expressing Solid Tumors
After
Phase 1/2 Study of BDC-1001 As a Single Agent and in Combination with Nivolumab in Patients with Advanced HER2-Expressing Solid Tumors
add /protocolSection/oversightModule/isUsExport
Triage: Uncategorized
Uncategorized Operation 13
After
false
Raw JSON Patch 
[
  {
    "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": "2025-02"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/overallStatus",
    "value": "TERMINATED"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/primaryCompletionDateStruct/date",
    "value": "2024-10-07"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/primaryCompletionDateStruct/type",
    "value": "ACTUAL"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/completionDateStruct/date",
    "value": "2025-02-14"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/completionDateStruct/type",
    "value": "ACTUAL"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2025-02-20"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2025-02-24"
  },
  {
    "op": "add",
    "path": "/protocolSection/statusModule/whyStopped",
    "value": "Sponsor Decision"
  },
  {
    "op": "add",
    "path": "/protocolSection/statusModule/expandedAccessInfo",
    "value": {
      "hasExpandedAccess": false
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/oversightModule/isUsExport",
    "value": false
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/19/state",
    "value": "Madrid"
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/20/state",
    "value": "Madrid"
  }
]