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A Phase I/IIa, Open-label, Multi-center Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of the ATR Kinase Inhibitor ART0380 Administered Orally as Monotherapy and in Combination to Patients With Advanced or Metastatic Solid Tumors

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Record identity and dates

Source
ClinicalTrials.gov
Source record ID
NCT04657068
Title field or adapter rule
{'original_value': 'A Phase I/IIa, Open-label, Multi-center Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of the ATR Kinase Inhibitor ART0380 Administered Orally as Monotherapy and in Combination to Patients With Advanced or Metastatic Solid Tumors', 'source_field': 'protocolSection.identificationModule.officialTitle'}
Ingested At
2026-10-31T23:27:22.631788+00:00
Published At
2026-10-22T00:00:00+00:00
Record Updated At
2026-10-22
Source Retrieved At
2026-10-31T22:17:25.750886+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
["Advanced Cancer", "Metastatic Cancer", "Ovarian Cancer", "Primary Peritoneal Cancer", "Fallopian Tube Cancer", "Endometrial Cancer", "Metastatic Colorectal Cancer", "Pancreatic Ductal Adenocarcinoma", "Acinar Cell Carcinoma"]
protocolSection.statusModule.lastUpdatePostDateStruct
{"date": "2026-10-22", "type": "ACTUAL"}
protocolSection.identificationModule.nctId
"NCT04657068"
protocolSection.identificationModule.officialTitle
"A Phase I/IIa, Open-label, Multi-center Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of the ATR Kinase Inhibitor ART0380 Administered Orally as Monotherapy and in Combination to Patients With Advanced or Metastatic Solid Tumors"
protocolSection.statusModule.overallStatus
"RECRUITING"
protocolSection.designModule.phases
["PHASE1", "PHASE2"]
protocolSection.statusModule.resultsFirstPostDateStruct
null

Study condition terms

  • Advanced Cancer (protocolSection.conditionsModule.conditions)
  • Metastatic Cancer (protocolSection.conditionsModule.conditions)
  • Ovarian Cancer (protocolSection.conditionsModule.conditions)
  • Primary Peritoneal Cancer (protocolSection.conditionsModule.conditions)
  • Fallopian Tube Cancer (protocolSection.conditionsModule.conditions)
  • Endometrial Cancer (protocolSection.conditionsModule.conditions)
  • Metastatic Colorectal Cancer (protocolSection.conditionsModule.conditions)
  • Pancreatic Ductal Adenocarcinoma (protocolSection.conditionsModule.conditions)
  • Acinar Cell Carcinoma (protocolSection.conditionsModule.conditions)

Interventions recorded in this study

  • {'armGroupLabels': ['Part A1', 'Part A2', 'Part A3', 'Part A3 Fed/Fast', 'Part B1', 'Part B2', 'Part B3', 'Part B4', 'Part B5', 'Part B6'], 'description': 'Participants will receive ART0380 by mouth either intermittently (either once daily 3 days on, 4 days off; days 2-4 and 9-11;or days 1-3 and 8-10) or continuously (once daily each day) in 21 day cycles.', 'name': 'ART0380', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
  • {'armGroupLabels': ['Part A2', 'Part B2'], 'description': 'Gemcitabine will be administered on Days 1 and 8 of a 21-day cycle.', 'name': 'Gemcitabine', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
  • {'armGroupLabels': ['Part A3', 'Part A3 Fed/Fast', 'Part B1', 'Part B5', 'Part B6'], 'description': 'Irinotecan will be administered as a 90-minute infusion on Days 1 and 8 of a 21 day cycle.', 'name': 'Irinotecan', '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

  • ART0380 (protocolSection.armsInterventionsModule.interventions[].name)
  • Gemcitabine (protocolSection.armsInterventionsModule.interventions[].name)
  • Irinotecan (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.