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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 6 to 7 · Bolt Biotherapeutics, Inc.

Patch inspector

Version 6 to 7

17 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
design_info_changephase_changeprimary_outcome_any_changesecondary_outcome_any_change
Value signals

None recorded.

Provenance
Source
ctgov_internal_history
Fetched
2026-06-18 19:11:04+00
Raw hash
7b2f60e93873a8532f38d660156450b3443604751d0821f43d0a8bae23754fc8
Payload
Source URL
Primary outcomes Outcome measures that define the trial's primary evidence target. Triage: Critical 3 ops
remove /protocolSection/outcomesModule/primaryOutcomes/5
Triage: Critical
Primary Outcome Change Operation 8
Matched rules
  • primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority.
Before
{
  "measure": "Duration of response (DOR) of confirmed complete or partial responses (CR, PR)",
  "timeFrame": "2 years",
  "description": "Expansion period only"
}
remove /protocolSection/outcomesModule/primaryOutcomes/5
Triage: Critical
Primary Outcome Change Operation 9
Matched rules
  • primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority.
Before
{
  "measure": "Disease control rate (DCR) of confirmed responses lasting 4 or more weeks",
  "timeFrame": "2 years",
  "description": "Expansion period only"
}
remove /protocolSection/outcomesModule/primaryOutcomes/5
Triage: Critical
Primary Outcome Change Operation 10
Matched rules
  • primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority.
Before
{
  "measure": "Progression free survival (PFS)",
  "timeFrame": "2 years",
  "description": "Expansion period only"
}
Design Trial model, phase, allocation, masking, arms, or interventions. Triage: High 3 ops
add /protocolSection/designModule/phases/1
Triage: High
Design Change Operation 5
Matched rules
  • phase_change Trial phase changes are high review-priority design changes.
After
PHASE2
replace /protocolSection/designModule/designInfo/interventionModel
Triage: High
Design Change Operation 6
Matched rules
  • design_info_change Design information changes can alter allocation, masking, model, or purpose and need review.
Before
SEQUENTIAL
After
PARALLEL
add /protocolSection/designModule/designInfo/interventionModelDescription
Triage: High
Design Change Operation 7
Matched rules
  • design_info_change Design information changes can alter allocation, masking, model, or purpose and need review.
After
Multiple ascending dose and dose-expansion of BDC-1001 administered as a single agent or in combination with pembrolizumab.
Secondary outcomes Additional endpoints and outcome descriptions. Triage: High 7 ops
add /protocolSection/outcomesModule/secondaryOutcomes/3
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.
After
{
  "measure": "PK (CL) of BDC-1001 as monotherapy and in combination with pembrolizumab",
  "timeFrame": "2 years",
  "description": "Escalation and expansion periods"
}
add /protocolSection/outcomesModule/secondaryOutcomes/4
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.
After
{
  "measure": "PK (Vz) of BDC-1001 as monotherapy and in combination with pembrolizumab",
  "timeFrame": "2 years",
  "description": "Escalation and expansion periods"
}
add /protocolSection/outcomesModule/secondaryOutcomes/5
Triage: High
Secondary Outcome Change Operation 13
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
After
{
  "measure": "PK (t1/2) of BDC-1001 as monotherapy and in combination with pembrolizumab",
  "timeFrame": "2 years",
  "description": "Escalation and expansion periods"
}
replace /protocolSection/outcomesModule/secondaryOutcomes/7/description
Triage: High
Secondary Outcome Change Operation 14
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
Escalation period only
After
Escalation and expansion periods
replace /protocolSection/outcomesModule/secondaryOutcomes/8/description
Triage: High
Secondary Outcome Change Operation 15
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
Escalation period only
After
Escalation and expansion periods
add /protocolSection/outcomesModule/secondaryOutcomes/9
Triage: High
Secondary Outcome Change Operation 16
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
After
{
  "measure": "Progression Free Survival (PFS)",
  "timeFrame": "2 years",
  "description": "Escalation and expansion periods"
}
add /protocolSection/outcomesModule/secondaryOutcomes/10
Triage: High
Secondary Outcome Change Operation 17
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
After
{
  "measure": "Overall Survival (OS)",
  "timeFrame": "2 years",
  "description": "Escalation period only"
}
Other registry fields Changes outside the current high-signal rule families. Triage: Uncategorized 3 ops
replace /protocolSection/statusModule/lastUpdateSubmitDate
Triage: Uncategorized
Uncategorized Operation 2
Before
2020-07-07
After
2020-07-24
replace /protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Uncategorized
Uncategorized Operation 3
Before
2020-07-08
After
2020-07-28
replace /protocolSection/descriptionModule/detailedDescription
Triage: Uncategorized
Uncategorized Operation 4
Before
This study has four parts.
Part 1 is a dose escalation of BDC-1001 as a single agent to determine the maximum tolerated dose (MTD) recommended for Part 3 and Phase 2 (RP2D).
In Part 3, the selected dose will be administered as monotherapy to patients with selected advanced malignancies.
Part 2 is a dose escalation of BDC-1001 in combination with pembrolizumab to determine the maximum tolerated dose (MTD) recommended for Part 4 and Phase 2 (RP2D).
In Part 4, the selected dose will be administered in combination with pembrolizumab to patients with selected advanced malignancies.
After
This study has four parts.
Part 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.
Part 2 is a dose escalation of BDC-1001 in combination with pembrolizumab 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 pembrolizumab to patients with selected advanced malignancies.
Sponsor and administrative fields Sponsor, collaborator, oversight, or registry maintenance changes. Triage: Uncategorized 1 ops
replace /protocolSection/identificationModule/officialTitle
Triage: Uncategorized
Uncategorized Operation 1
Before
Phase 1 Study of BDC-1001 as a Single Agent and in Combination With Pembrolizumab in Patients With Advanced and HER2-Expressing Solid Tumors
After
Phase 1/2 Study of BDC-1001 as a Single Agent and in Combination With Pembrolizumab in Patients With Advanced HER2-Expressing Solid Tumors
Raw JSON Patch 
[
  {
    "op": "replace",
    "path": "/protocolSection/identificationModule/officialTitle",
    "value": "Phase 1/2 Study of BDC-1001 as a Single Agent and in Combination With Pembrolizumab in Patients With Advanced HER2-Expressing Solid Tumors"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2020-07-24"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2020-07-28"
  },
  {
    "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 pembrolizumab 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 pembrolizumab to patients with selected advanced malignancies."
  },
  {
    "op": "add",
    "path": "/protocolSection/designModule/phases/1",
    "value": "PHASE2"
  },
  {
    "op": "replace",
    "path": "/protocolSection/designModule/designInfo/interventionModel",
    "value": "PARALLEL"
  },
  {
    "op": "add",
    "path": "/protocolSection/designModule/designInfo/interventionModelDescription",
    "value": "Multiple ascending dose and dose-expansion of BDC-1001 administered as a single agent or in combination with pembrolizumab."
  },
  {
    "op": "remove",
    "path": "/protocolSection/outcomesModule/primaryOutcomes/5"
  },
  {
    "op": "remove",
    "path": "/protocolSection/outcomesModule/primaryOutcomes/5"
  },
  {
    "op": "remove",
    "path": "/protocolSection/outcomesModule/primaryOutcomes/5"
  },
  {
    "op": "add",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/3",
    "value": {
      "measure": "PK (CL) of BDC-1001 as monotherapy and in combination with pembrolizumab",
      "timeFrame": "2 years",
      "description": "Escalation and expansion periods"
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/4",
    "value": {
      "measure": "PK (Vz) of BDC-1001 as monotherapy and in combination with pembrolizumab",
      "timeFrame": "2 years",
      "description": "Escalation and expansion periods"
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/5",
    "value": {
      "measure": "PK (t1/2) of BDC-1001 as monotherapy and in combination with pembrolizumab",
      "timeFrame": "2 years",
      "description": "Escalation and expansion periods"
    }
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/7/description",
    "value": "Escalation and expansion periods"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/8/description",
    "value": "Escalation and expansion periods"
  },
  {
    "op": "add",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/9",
    "value": {
      "measure": "Progression Free Survival (PFS)",
      "timeFrame": "2 years",
      "description": "Escalation and expansion periods"
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/10",
    "value": {
      "measure": "Overall Survival (OS)",
      "timeFrame": "2 years",
      "description": "Escalation period only"
    }
  }
]