First-in-Human, Phase 1/1b, Open-label, Multicenter Study of Bifunctional EGFR/TGFβ Fusion Protein BCA101 Monotherapy and in Combination Therapy in Patients With EGFR-Driven Advanced Solid Tumors

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Record identity and dates

Source

ClinicalTrials.gov

Source record ID

NCT04429542

Title field or adapter rule

{'original_value': 'First-in-Human, Phase 1/1b, Open-label, Multicenter Study of Bifunctional EGFR/TGFβ Fusion Protein BCA101 Monotherapy and in Combination Therapy in Patients With EGFR-Driven Advanced Solid Tumors', 'source_field': 'protocolSection.identificationModule.officialTitle'}

Ingested At

2026-10-31T23:27:24.049199+00:00

Published At

2026-10-06T00:00:00+00:00

Record Updated At

2026-10-06

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

["Head and Neck Squamous Cell Carcinoma", "Squamous Cell Carcinoma of Anal Canal", "Colorectal Cancer", "Squamous Cell Carcinoma of the Lung", "EGFR Amplification", "Epithelial Ovarian Cancer", "Pancreas Cancer", "Cutaneous Squamous Cell Carcinoma", "Head and Neck Neoplasms", "Carcinoma, Squamous Cell", "Squamous Cell Carcinoma of Head and Neck"]

protocolSection.statusModule.lastUpdatePostDateStruct

{"date": "2026-10-06", "type": "ACTUAL"}

protocolSection.identificationModule.nctId

"NCT04429542"

protocolSection.identificationModule.officialTitle

"First-in-Human, Phase 1/1b, Open-label, Multicenter Study of Bifunctional EGFR/TGF\u03b2 Fusion Protein BCA101 Monotherapy and in Combination Therapy in Patients With EGFR-Driven Advanced Solid Tumors"

protocolSection.statusModule.overallStatus

"RECRUITING"

protocolSection.designModule.phases

["PHASE1"]

protocolSection.statusModule.resultsFirstPostDateStruct

null

Study condition terms

• Head and Neck Squamous Cell Carcinoma (protocolSection.conditionsModule.conditions)
• Squamous Cell Carcinoma of Anal Canal (protocolSection.conditionsModule.conditions)
• Colorectal Cancer (protocolSection.conditionsModule.conditions)
• Squamous Cell Carcinoma of the Lung (protocolSection.conditionsModule.conditions)
• EGFR Amplification (protocolSection.conditionsModule.conditions)
• Epithelial Ovarian Cancer (protocolSection.conditionsModule.conditions)
• Pancreas Cancer (protocolSection.conditionsModule.conditions)
• Cutaneous Squamous Cell Carcinoma (protocolSection.conditionsModule.conditions)
• Head and Neck Neoplasms (protocolSection.conditionsModule.conditions)
• Carcinoma, Squamous Cell (protocolSection.conditionsModule.conditions)
• Squamous Cell Carcinoma of Head and Neck (protocolSection.conditionsModule.conditions)

Interventions recorded in this study

• {'armGroupLabels': ['BCA101 + pembrolizumab', 'BCA101 Monotherapy'], 'description': 'EGFR/TGFβ fusion monoclonal antibody', 'name': 'BCA101', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
• {'armGroupLabels': ['BCA101 + pembrolizumab'], 'description': 'anti-PD-1', 'name': 'Pembrolizumab', '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

• BCA101 (protocolSection.armsInterventionsModule.interventions[].name)
• Pembrolizumab (protocolSection.armsInterventionsModule.interventions[].name)

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

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