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NCT04478279

A Phase 1-2 Study of ST101 in Patients With Advanced Solid Tumors

Version 13 to 14 · Sapience Therapeutics

Patch inspector

Version 13 to 14

12 operations 3 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_change
Value signals

None recorded.

Provenance
Source
ctgov_internal_history
Fetched
2026-06-18 18:57:42+00
Raw hash
94109c16cf384f046c03b3d9b5d08960724bfe0d6d85e84c26df1683dd30eed9
Payload
Source URL
Design Trial model, phase, allocation, masking, arms, or interventions. Triage: High 4 ops
add /protocolSection/armsInterventionsModule/armGroups/5
Triage: High
Arm Intervention Change Operation 8
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
{
  "type": "EXPERIMENTAL",
  "label": "Dose Expansion Recurrent Glioblastoma",
  "description": "Recurrent GBM patients must have completed radiation at least 3 months prior to minimize the inclusion of patients with pseudoprogression.\nRecurrent GBM patients must have unequivocal radiographic evidence of tumor progression by contrast-enhanced magnetic resonance imaging (MRI) scan within 21 days prior to registration.\nPatients must be able to delay surgery for 2 - 4 weeks per investigator decision",
  "interventionNames": [
    "Drug: ST101"
  ]
}
add /protocolSection/armsInterventionsModule/armGroups/6
Triage: High
Arm Intervention Change Operation 9
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
{
  "type": "EXPERIMENTAL",
  "label": "Newly Diagnosed Glioblastoma",
  "description": "Newly diagnosed patients with a suboptimal resection or biopsy must be candidates for another surgical resection as determined by neurosurgical evaluation or multidisciplinary team based on the current standard of care that suggests that maximal safe resection is beneficial.\nRecurrent GBM patients must be candidates for tumor resection",
  "interventionNames": [
    "Drug: ST101"
  ]
}
add /protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/5
Triage: High
Arm Intervention Change Operation 10
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
Dose Expansion Recurrent Glioblastoma
add /protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/6
Triage: High
Arm Intervention Change Operation 11
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
Newly Diagnosed Glioblastoma
Contacts and locations Site, contact, and location updates that are usually operational. Triage: Uncategorized 1 ops
replace /protocolSection/contactsLocationsModule/overallOfficials/1/name
Triage: Uncategorized
Uncategorized Operation 12
Before
Yasser Kamel, MD
After
Abi Vainstein-Haras, MD
Other registry fields Changes outside the current high-signal rule families. Triage: Uncategorized 7 ops
replace /protocolSection/statusModule/statusVerifiedDate
Triage: Uncategorized
Uncategorized Operation 1
Before
2022-11
After
2023-02
replace /protocolSection/statusModule/lastUpdateSubmitDate
Triage: Uncategorized
Uncategorized Operation 2
Before
2022-11-15
After
2023-02-14
replace /protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Uncategorized
Uncategorized Operation 3
Before
2022-11-18
After
2023-02-16
remove /protocolSection/conditionsModule/conditions/2
Triage: Uncategorized
Uncategorized Operation 4
Before
Melanoma Recurrent
add /protocolSection/conditionsModule/conditions/10
Triage: Uncategorized
Uncategorized Operation 5
After
Melanoma Recurrent
add /protocolSection/conditionsModule/conditions/12
Triage: Uncategorized
Uncategorized Operation 6
After
Recurrent Glioblastoma
add /protocolSection/conditionsModule/conditions/13
Triage: Uncategorized
Uncategorized Operation 7
After
Newly Diagnosed Glioblastoma
Raw JSON Patch
[
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/statusVerifiedDate",
    "value": "2023-02"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2023-02-14"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2023-02-16"
  },
  {
    "op": "remove",
    "path": "/protocolSection/conditionsModule/conditions/2"
  },
  {
    "op": "add",
    "path": "/protocolSection/conditionsModule/conditions/10",
    "value": "Melanoma Recurrent"
  },
  {
    "op": "add",
    "path": "/protocolSection/conditionsModule/conditions/12",
    "value": "Recurrent Glioblastoma"
  },
  {
    "op": "add",
    "path": "/protocolSection/conditionsModule/conditions/13",
    "value": "Newly Diagnosed Glioblastoma"
  },
  {
    "op": "add",
    "path": "/protocolSection/armsInterventionsModule/armGroups/5",
    "value": {
      "type": "EXPERIMENTAL",
      "label": "Dose Expansion Recurrent Glioblastoma",
      "description": "Recurrent GBM patients must have completed radiation at least 3 months prior to minimize the inclusion of patients with pseudoprogression.\nRecurrent GBM patients must have unequivocal radiographic evidence of tumor progression by contrast-enhanced magnetic resonance imaging (MRI) scan within 21 days prior to registration.\nPatients must be able to delay surgery for 2 - 4 weeks per investigator decision",
      "interventionNames": [
        "Drug: ST101"
      ]
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/armsInterventionsModule/armGroups/6",
    "value": {
      "type": "EXPERIMENTAL",
      "label": "Newly Diagnosed Glioblastoma",
      "description": "Newly diagnosed patients with a suboptimal resection or biopsy must be candidates for another surgical resection as determined by neurosurgical evaluation or multidisciplinary team based on the current standard of care that suggests that maximal safe resection is beneficial.\nRecurrent GBM patients must be candidates for tumor resection",
      "interventionNames": [
        "Drug: ST101"
      ]
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/5",
    "value": "Dose Expansion Recurrent Glioblastoma"
  },
  {
    "op": "add",
    "path": "/protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/6",
    "value": "Newly Diagnosed Glioblastoma"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/overallOfficials/1/name",
    "value": "Abi Vainstein-Haras, MD"
  }
]