A First-in-Human, Phase 1/2 Trial to Assess the Safety, Tolerability and Preliminary Efficacy of Sofetabart Mipitecan (LY4170156), an Antibody-Drug Conjugate Targeting Folate Receptor α-Expressing Tumor Cells, in Participants With Selected Advanced Solid Tumors

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Record identity and dates

Source

ClinicalTrials.gov

Source record ID

NCT06400472

Title field or adapter rule

{'original_value': 'A First-in-Human, Phase 1/2 Trial to Assess the Safety, Tolerability and Preliminary Efficacy of Sofetabart Mipitecan (LY4170156), an Antibody-Drug Conjugate Targeting Folate Receptor α-Expressing Tumor Cells, in Participants With Selected Advanced Solid Tumors', 'source_field': 'protocolSection.identificationModule.officialTitle'}

Ingested At

2026-10-31T23:27:23.896514+00:00

Published At

2026-10-07T00:00:00+00:00

Record Updated At

2026-10-07

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

["Ovarian Neoplasms", "Endometrial Neoplasms", "Uterine Cervical Neoplasms", "Carcinoma, Non-Small-Cell Lung", "Triple Negative Breast Neoplasms", "Pancreatic Neoplasm", "Colorectal Neoplasms"]

protocolSection.statusModule.lastUpdatePostDateStruct

{"date": "2026-10-07", "type": "ACTUAL"}

protocolSection.identificationModule.nctId

"NCT06400472"

protocolSection.identificationModule.officialTitle

"A First-in-Human, Phase 1/2 Trial to Assess the Safety, Tolerability and Preliminary Efficacy of Sofetabart Mipitecan (LY4170156), an Antibody-Drug Conjugate Targeting Folate Receptor \u03b1-Expressing Tumor Cells, in Participants With Selected Advanced Solid Tumors"

protocolSection.statusModule.overallStatus

"RECRUITING"

protocolSection.designModule.phases

["PHASE1"]

protocolSection.statusModule.resultsFirstPostDateStruct

null

Study condition terms

• Ovarian Neoplasms (protocolSection.conditionsModule.conditions)
• Endometrial Neoplasms (protocolSection.conditionsModule.conditions)
• Uterine Cervical Neoplasms (protocolSection.conditionsModule.conditions)
• Carcinoma, Non-Small-Cell Lung (protocolSection.conditionsModule.conditions)
• Triple Negative Breast Neoplasms (protocolSection.conditionsModule.conditions)
• Pancreatic Neoplasm (protocolSection.conditionsModule.conditions)
• Colorectal Neoplasms (protocolSection.conditionsModule.conditions)

Interventions recorded in this study

• {'armGroupLabels': ['Sofe-M (Cohort A1 Parts A and C)', 'Sofe-M (Combination Cohort A4)', 'Sofe-M (Combination Cohort A5)', 'Sofe-M (Dose-escalation, Cohort A1)', 'Sofe-M (Dose-expansion, Cohort B1)', 'Sofe-M (Dose-expansion, Cohort B2-B4)', 'Sofe-M (Dose-optimization, Cohort A2)', 'Sofe-M (Enrichment Cohort A3)', 'Sofe-M Alone or with Itraconazole. Drug-Drug Interaction (DDI) (Cohort A1: Arm B)', 'Sofe-M Combination with Pembrolizumab (Dose-optimization Cohort A6)', 'Sofe-M Combination with carboplatin and optional bevacizumab (Dose-optimization Cohort A7)'], 'description': 'Intravenous', 'name': 'Sofe-M', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
• {'armGroupLabels': ['Sofe-M (Combination Cohort A4)', 'Sofe-M Combination with carboplatin and optional bevacizumab (Dose-optimization Cohort A7)'], 'description': 'IV', 'name': 'bevacizumab', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
• {'armGroupLabels': ['Sofe-M (Combination Cohort A5)', 'Sofe-M Combination with carboplatin and optional bevacizumab (Dose-optimization Cohort A7)'], 'description': 'IV', 'name': 'carboplatin', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
• {'armGroupLabels': ['Sofe-M Alone or with Itraconazole. Drug-Drug Interaction (DDI) (Cohort A1: Arm B)'], 'description': 'oral', 'name': 'Itraconazole', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
• {'armGroupLabels': ['Sofe-M Combination with Pembrolizumab (Dose-optimization Cohort A6)'], 'description': 'IV', '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

• Sofe-M (protocolSection.armsInterventionsModule.interventions[].name)
• bevacizumab (protocolSection.armsInterventionsModule.interventions[].name)
• carboplatin (protocolSection.armsInterventionsModule.interventions[].name)
• Itraconazole (protocolSection.armsInterventionsModule.interventions[].name)
• pembrolizumab (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.