A First-in-Human Phase 1/2 Dose Escalation and Treatment Optimization Study Evaluating Safety, Tolerability, and Preliminary Efficacy of [225Ac]Ac-FL-261 in Participants With Solid Tumors Overexpressing c-MET

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Record identity and dates

Source

ClinicalTrials.gov

Source record ID

NCT07873450

Title field or adapter rule

{'original_value': 'A First-in-Human Phase 1/2 Dose Escalation and Treatment Optimization Study Evaluating Safety, Tolerability, and Preliminary Efficacy of [225Ac]Ac-FL-261 in Participants With Solid Tumors Overexpressing c-MET', 'source_field': 'protocolSection.identificationModule.officialTitle'}

Ingested At

2026-10-31T23:27:28.856364+00:00

Published At

2026-10-29T00:00:00+00:00

Record Updated At

2026-10-29

Source Retrieved At

2026-10-31T22:18:26.854673+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

["Solid Tumor", "NSCLC", "Colorectal Cancer", "Head and Neck Cancer", "Cholangiocarcinoma"]

protocolSection.statusModule.lastUpdatePostDateStruct

{"date": "2026-10-29", "type": "ACTUAL"}

protocolSection.identificationModule.nctId

"NCT07873450"

protocolSection.identificationModule.officialTitle

"A First-in-Human Phase 1/2 Dose Escalation and Treatment Optimization Study Evaluating Safety, Tolerability, and Preliminary Efficacy of [225Ac]Ac-FL-261 in Participants With Solid Tumors Overexpressing c-MET"

protocolSection.statusModule.overallStatus

"RECRUITING"

protocolSection.designModule.phases

["PHASE1", "PHASE2"]

protocolSection.statusModule.resultsFirstPostDateStruct

null

Study condition terms

• Solid Tumor (protocolSection.conditionsModule.conditions)
• NSCLC (protocolSection.conditionsModule.conditions)
• Colorectal Cancer (protocolSection.conditionsModule.conditions)
• Head and Neck Cancer (protocolSection.conditionsModule.conditions)
• Cholangiocarcinoma (protocolSection.conditionsModule.conditions)

Interventions recorded in this study

• {'armGroupLabels': ['Phase 1 - Dose Escalation'], 'description': 'Dose escalation per BOIN design to determine MTD.', 'name': '[225Ac]Ac-FL-261', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
• {'armGroupLabels': ['Phase 1 - Dose Optimization'], 'description': 'Two candidate dosing regimens, randomized 1:1 (30 participants per arm)', 'name': '[225Ac]Ac-FL-261', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
• {'armGroupLabels': ['Phase 2'], 'description': '* Non-squamous non-small cell lung cancer (NSCLC)\n* Colorectal cancer (CRC)\n* Head and neck squamous cell carcinoma (HNSCC)\n* Cholangiocarcinoma', 'name': '[225Ac]Ac-FL-261', '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

• [225Ac]Ac-FL-261 (protocolSection.armsInterventionsModule.interventions[].name)
• [225Ac]Ac-FL-261 (protocolSection.armsInterventionsModule.interventions[].name)
• [225Ac]Ac-FL-261 (protocolSection.armsInterventionsModule.interventions[].name)

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

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