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Safety, Pharmacokinetics (PK), and Efficacy of ONC-392 as a Single Agent and in Combination With Pembrolizumab in Advanced Solid Tumors and NSCLC: An Open Label Phase IA/IB Study. Preserve CTLA4 Checkpoint Function (PRESERVE-001)

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Record identity and dates

Source
ClinicalTrials.gov
Source record ID
NCT04140526
Title field or adapter rule
{'original_value': 'Safety, Pharmacokinetics (PK), and Efficacy of ONC-392 as a Single Agent and in Combination With Pembrolizumab in Advanced Solid Tumors and NSCLC: An Open Label Phase IA/IB Study. Preserve CTLA4 Checkpoint Function (PRESERVE-001)', 'source_field': 'protocolSection.identificationModule.officialTitle'}
Ingested At
2026-10-31T23:27:25.868973+00:00
Published At
2026-09-14T00:00:00+00:00
Record Updated At
2026-09-14
Source Retrieved At
2026-10-31T22:17:56.788771+00:00
Timestamp Basis
ClinicalTrials.gov API/RSS response retrieval timestamp recorded by Dossier adapter
Date limitation
ClinicalTrials.gov API/RSS response retrieval timestamp recorded by Dossier adapter

Fields recorded by this source

protocolSection.conditionsModule.conditions
["Non Small Cell Lung Cancer", "Advanced Solid Tumor", "Metastatic Melanoma", "Metastatic Head and Neck Carcinoma", "Metastatic Renal Cell Carcinoma", "Metastatic Colorectal Cancer", "Sarcomas", "Metastatic Prostate Cancer", "Ovarian Cancer", "Small Cell Lung Cancer", "Metastatic Breast Cancer", "Pancreas Cancer", "Gastric Cancer", "Esophageal Cancer", "Gastroesophageal Junction Adenocarcinoma", "Cervical Cancer", "Adenoid Cystic Carcinoma", "Salivary Gland Cancer", "Urothelial Carcinoma"]
protocolSection.statusModule.lastUpdatePostDateStruct
{"date": "2026-09-14", "type": "ACTUAL"}
protocolSection.identificationModule.nctId
"NCT04140526"
protocolSection.identificationModule.officialTitle
"Safety, Pharmacokinetics (PK), and Efficacy of ONC-392 as a Single Agent and in Combination With Pembrolizumab in Advanced Solid Tumors and NSCLC: An Open Label Phase IA/IB Study. Preserve CTLA4 Checkpoint Function (PRESERVE-001)"
protocolSection.statusModule.overallStatus
"ACTIVE_NOT_RECRUITING"
protocolSection.designModule.phases
["PHASE1", "PHASE2"]
protocolSection.statusModule.resultsFirstPostDateStruct
null

Study condition terms

  • Non Small Cell Lung Cancer (protocolSection.conditionsModule.conditions)
  • Advanced Solid Tumor (protocolSection.conditionsModule.conditions)
  • Metastatic Melanoma (protocolSection.conditionsModule.conditions)
  • Metastatic Head and Neck Carcinoma (protocolSection.conditionsModule.conditions)
  • Metastatic Renal Cell Carcinoma (protocolSection.conditionsModule.conditions)
  • Metastatic Colorectal Cancer (protocolSection.conditionsModule.conditions)
  • Sarcomas (protocolSection.conditionsModule.conditions)
  • Metastatic Prostate Cancer (protocolSection.conditionsModule.conditions)
  • Ovarian Cancer (protocolSection.conditionsModule.conditions)
  • Small Cell Lung Cancer (protocolSection.conditionsModule.conditions)
  • Metastatic Breast Cancer (protocolSection.conditionsModule.conditions)
  • Pancreas Cancer (protocolSection.conditionsModule.conditions)
  • Gastric Cancer (protocolSection.conditionsModule.conditions)
  • Esophageal Cancer (protocolSection.conditionsModule.conditions)
  • Gastroesophageal Junction Adenocarcinoma (protocolSection.conditionsModule.conditions)
  • Cervical Cancer (protocolSection.conditionsModule.conditions)
  • Adenoid Cystic Carcinoma (protocolSection.conditionsModule.conditions)
  • Salivary Gland Cancer (protocolSection.conditionsModule.conditions)
  • Urothelial Carcinoma (protocolSection.conditionsModule.conditions)

Interventions recorded in this study

  • {'armGroupLabels': ['ONC-392 Treatment as single agent', 'ONC-392 and docetaxel', 'ONC-392 in combination with pembrolizumab'], 'description': 'ONC-392 will be given by intravenous infusion, once every 21 days (Q3W). In Part C Arm M and in Part D, ONC-392 will be given Q4W.', 'name': 'ONC-392', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
  • {'armGroupLabels': ['ONC-392 in combination with pembrolizumab'], 'description': 'Pembrolizumab will be given intravenous (IV) infusion at 200 mg/cycle, once every 21 days (Q3W).', 'name': 'Pembrolizumab', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
  • {'armGroupLabels': ['ONC-392 and docetaxel'], 'description': 'Docetaxel will be given intravenous (IV) infusion at 75 mg/m2, once every 21 days (Q3W).', 'name': 'Docetaxel', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])

An intervention appearing in a study record does not establish an effect or an approved use.

Drug names recorded in this source

  • ONC-392 (protocolSection.armsInterventionsModule.interventions[].name)
  • Pembrolizumab (protocolSection.armsInterventionsModule.interventions[].name)
  • Docetaxel (protocolSection.armsInterventionsModule.interventions[].name)

A recorded drug name is not by itself an indication or a condition-specific relationship.

This index keeps the source fields it imported; it may not contain the complete original record. Verify wording and context in the linked source.