NCT04278144
Version 29 to 30 · Bolt Biotherapeutics, Inc.
Patch inspector
Manual review pending.
enrollment_count_changeenrollment_type_change [
{
"path": "/protocolSection/statusModule/completionDateStruct/date",
"signal": "timeline_earlier_adjustment",
"category": "timeline_minor_adjustment",
"new_type": "ESTIMATED",
"old_type": "ESTIMATED",
"severity": "low",
"direction": "earlier",
"new_value": "2026-01-31",
"old_value": "2026-10-31",
"delta_days": 273,
"date_struct": "completionDateStruct",
"new_precision": "day",
"old_precision": "day"
},
{
"path": "/protocolSection/designModule/enrollmentInfo/count",
"signal": "enrollment_count_change_ge_20pct",
"category": "enrollment_change",
"severity": "high",
"new_value": 175,
"old_value": 390,
"pct_change": 0.5513
}
] a26fe8250d20164bf2573dbc23c0176e3eeb823b62cec3dd5baf40a63c4fb59f/protocolSection/designModule/enrollmentInfo/count enrollment_count_change Enrollment count changes can signal scope or feasibility shifts. 390
175
/protocolSection/designModule/enrollmentInfo/type enrollment_type_change Enrollment type changes from anticipated to actual or similar are high review priority. ESTIMATED
ACTUAL
/protocolSection/statusModule/completionDateStruct/date completion_timeline_change Completion date changes are operational timeline signals. 2026-10-31
2026-01-31
/protocolSection/contactsLocationsModule/locations/14 {
"zip": "35042",
"city": "Rennes",
"country": "France",
"facility": "Centre Eugene Marquis",
"geoPoint": {
"lat": 48.11109,
"lon": -1.67431
}
} /protocolSection/contactsLocationsModule/locations/15 {
"zip": "80131",
"city": "Naples",
"state": "Campania",
"country": "Italy",
"facility": "Istituto Nazionale Tumori IRCCS Fondazione G. Pascale",
"geoPoint": {
"lat": 40.85216,
"lon": 14.26811
}
} /protocolSection/contactsLocationsModule/locations/15 {
"zip": "20089",
"city": "Milan",
"state": "Lombardy",
"country": "Italy",
"facility": "Instituto Clinico Humanitas",
"geoPoint": {
"lat": 45.46427,
"lon": 9.18951
}
} /protocolSection/contactsLocationsModule/locations/20 {
"zip": "08908",
"city": "Barcelona",
"country": "Spain",
"facility": "Institut Catala D'Oncologia",
"geoPoint": {
"lat": 41.38879,
"lon": 2.15899
}
} /protocolSection/statusModule/lastUpdateSubmitDate 2024-05-28
2024-08-16
/protocolSection/statusModule/lastUpdatePostDateStruct/date 2024-05-30
2024-08-20
/protocolSection/descriptionModule/detailedDescription 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 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.
<p>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 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.</p><p>Bolt amended the protocol to transition any subjects still receiving BDC-1001 to continue receiving BDC-1001 in the Maintenance Phase. Subjects remaining on BDC-1001 will continue to receive BDC-1001 until a criterion for discontinuation has been met.</p>
/protocolSection/ipdSharingStatementModule {
"ipdSharing": "NO"
} [
{
"op": "replace",
"path": "/protocolSection/statusModule/completionDateStruct/date",
"value": "2026-01-31"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdateSubmitDate",
"value": "2024-08-16"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
"value": "2024-08-20"
},
{
"op": "replace",
"path": "/protocolSection/descriptionModule/detailedDescription",
"value": "<p>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.</p><p>Bolt amended the protocol to transition any subjects still receiving BDC-1001 to continue receiving BDC-1001 in the Maintenance Phase.\nSubjects remaining on BDC-1001 will continue to receive BDC-1001 until a criterion for discontinuation has been met.</p>"
},
{
"op": "replace",
"path": "/protocolSection/designModule/enrollmentInfo/count",
"value": 175
},
{
"op": "replace",
"path": "/protocolSection/designModule/enrollmentInfo/type",
"value": "ACTUAL"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/14"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/15"
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{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/15"
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{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/20"
},
{
"op": "add",
"path": "/protocolSection/ipdSharingStatementModule",
"value": {
"ipdSharing": "NO"
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}
]