A Phase 1, First-in-human, Multicentre, Open-label, Dose Escalation Study of [225Ac]-FPI-2068 in Adult Patients With Advanced Solid Tumours

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Record identity and dates

Source

ClinicalTrials.gov

Source record ID

NCT06147037

Title field or adapter rule

{'original_value': 'A Phase 1, First-in-human, Multicentre, Open-label, Dose Escalation Study of [225Ac]-FPI-2068 in Adult Patients With Advanced Solid Tumours', 'source_field': 'protocolSection.identificationModule.officialTitle'}

Ingested At

2026-10-31T23:27:24.423807+00:00

Published At

2026-09-30T00:00:00+00:00

Record Updated At

2026-09-30

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 Tumor", "Metastatic Colorectal Carcinoma", "Head and Neck Squamous Cell Carcinoma", "Non-small Cell Lung Cancer", "Pancreatic Ductal Adenocarcinoma", "Gastric Cancer", "Renal Cell Carcinoma"]

protocolSection.statusModule.lastUpdatePostDateStruct

{"date": "2026-09-30", "type": "ACTUAL"}

protocolSection.identificationModule.nctId

"NCT06147037"

protocolSection.identificationModule.officialTitle

"A Phase 1, First-in-human, Multicentre, Open-label, Dose Escalation Study of [225Ac]-FPI-2068 in Adult Patients With Advanced Solid Tumours"

protocolSection.statusModule.overallStatus

"ACTIVE_NOT_RECRUITING"

protocolSection.designModule.phases

["PHASE1"]

protocolSection.statusModule.resultsFirstPostDateStruct

null

Study condition terms

• Advanced Solid Tumor (protocolSection.conditionsModule.conditions)
• Metastatic Colorectal Carcinoma (protocolSection.conditionsModule.conditions)
• Head and Neck Squamous Cell Carcinoma (protocolSection.conditionsModule.conditions)
• Non-small Cell Lung Cancer (protocolSection.conditionsModule.conditions)
• Pancreatic Ductal Adenocarcinoma (protocolSection.conditionsModule.conditions)
• Gastric Cancer (protocolSection.conditionsModule.conditions)
• Renal Cell Carcinoma (protocolSection.conditionsModule.conditions)

Interventions recorded in this study

• {'armGroupLabels': ['Dose Exploration and Dose Escalation'], 'description': 'FPI-2053 is a bispecific antibody that targets EGFR and cMET', 'name': 'FPI-2053', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
• {'armGroupLabels': ['Dose Exploration and Dose Escalation'], 'description': '\\[111In\\]-FPI-2107 is an imaging agent in which indium-111 is conjugated to FPI-2053.\n\nParticipants will have a fixed dose of \\[111In\\]-FPI-2107 followed by imaging scans (with or without pre-administration of FPI-2053).', 'name': '[111In]-FPI-2107', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
• {'armGroupLabels': ['Dose Exploration and Dose Escalation'], 'description': '\\[225Ac\\]-FPI-2068 is a radiopharmaceutical therapy in which an alpha emitter, actinium-225, is conjugated to FPI-2053.\n\nParticipants will be dosed through IV administration every 56 days for up to 3 cycles of the Treatment Period.', 'name': '[225Ac]-FPI-2068', '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

• FPI-2053 (protocolSection.armsInterventionsModule.interventions[].name)
• [111In]-FPI-2107 (protocolSection.armsInterventionsModule.interventions[].name)
• [225Ac]-FPI-2068 (protocolSection.armsInterventionsModule.interventions[].name)

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

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