A Multi-center, Open-label Phase Ib/II Study Exploring the Safety/Tolerability, Pharmacokinetics, and Efficacy of GFH276 in Combination With Cetuximab or Chemotherapy in the Treatment of Patients With Advanced Solid Tumors and Pancreatic Ductal Adenocarcinoma (PDAC) Harboring RAS Mutation

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Record identity and dates

Source

ClinicalTrials.gov

Source record ID

NCT07678593

Title field or adapter rule

{'original_value': 'A Multi-center, Open-label Phase Ib/II Study Exploring the Safety/Tolerability, Pharmacokinetics, and Efficacy of GFH276 in Combination With Cetuximab or Chemotherapy in the Treatment of Patients With Advanced Solid Tumors and Pancreatic Ductal Adenocarcinoma (PDAC) Harboring RAS Mutation', 'source_field': 'protocolSection.identificationModule.officialTitle'}

Ingested At

2026-10-31T23:27:24.126560+00:00

Published At

2026-10-05T00:00:00+00:00

Record Updated At

2026-10-05

Source Retrieved At

2026-10-31T22:17:54.613222+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 Solid Tumors Cancer", "Pancreatic Ductal Adenocarcinoma", "RAS Mutation"]

protocolSection.statusModule.lastUpdatePostDateStruct

{"date": "2026-10-05", "type": "ACTUAL"}

protocolSection.identificationModule.nctId

"NCT07678593"

protocolSection.identificationModule.officialTitle

"A Multi-center, Open-label Phase Ib/II Study Exploring the Safety/Tolerability, Pharmacokinetics, and Efficacy of GFH276 in Combination With Cetuximab or Chemotherapy in the Treatment of Patients With Advanced Solid Tumors and Pancreatic Ductal Adenocarcinoma (PDAC) Harboring RAS Mutation"

protocolSection.statusModule.overallStatus

"RECRUITING"

protocolSection.designModule.phases

["PHASE1", "PHASE2"]

protocolSection.statusModule.resultsFirstPostDateStruct

null

Study condition terms

• Advanced Solid Tumors Cancer (protocolSection.conditionsModule.conditions)
• Pancreatic Ductal Adenocarcinoma (protocolSection.conditionsModule.conditions)
• RAS Mutation (protocolSection.conditionsModule.conditions)

Interventions recorded in this study

• {'armGroupLabels': ['Arm A: GFH276 + Cetuximab', 'Arm B: GFH276 + AG', 'Arm C: GFH276 + mFOLFIRINOX'], 'description': 'Oral GFH276 administered once daily in combination with other study drugs.', 'name': 'GFH276', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
• {'armGroupLabels': ['Arm A: GFH276 + Cetuximab'], 'description': 'Intravenous cetuximab at a dose of 500 mg/m²', 'name': 'Cetuximab', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
• {'armGroupLabels': ['Arm B: GFH276 + AG'], 'description': 'Intravenous nab-paclitaxel at a dose of 125 mg/m².', 'name': 'Nab paclitaxel', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
• {'armGroupLabels': ['Arm B: GFH276 + AG'], 'description': 'Intravenous Gemcitabine at a dose of 1000 mg/m².', 'name': 'Gemcitabine', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
• {'armGroupLabels': ['Arm C: GFH276 + mFOLFIRINOX'], 'description': 'Intravenous Fluorouracil at a dose of 2400 mg/m² via 46-hour infusion.Dosing may follow the above regimen or local institutional standards.', 'name': 'Fluorouracil', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
• {'armGroupLabels': ['Arm C: GFH276 + mFOLFIRINOX'], 'description': 'Intravenous leucovorin at a dose of 400 mg/m².Dosing may follow the above regimen or local institutional standards.', 'name': 'Leucovorin', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
• {'armGroupLabels': ['Arm C: GFH276 + mFOLFIRINOX'], 'description': 'Intravenous irinotecan at a dose of 150 mg/m².Dosing may follow the above regimen or local institutional standards.', 'name': 'Irinotecan', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
• {'armGroupLabels': ['Arm C: GFH276 + mFOLFIRINOX'], 'description': 'Intravenous oxaliplatin at a dose of 85 mg/m².Dosing may follow the above regimen or local institutional standards.', 'name': 'Oxaliplatin', '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

• GFH276 (protocolSection.armsInterventionsModule.interventions[].name)
• Cetuximab (protocolSection.armsInterventionsModule.interventions[].name)
• Nab paclitaxel (protocolSection.armsInterventionsModule.interventions[].name)
• Gemcitabine (protocolSection.armsInterventionsModule.interventions[].name)
• Fluorouracil (protocolSection.armsInterventionsModule.interventions[].name)
• Leucovorin (protocolSection.armsInterventionsModule.interventions[].name)
• Irinotecan (protocolSection.armsInterventionsModule.interventions[].name)
• Oxaliplatin (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.