CLINICAL_TRIALS ClinicalTrials.gov record update

Phase I/II Study of the Safety, Pharmacokinetics, and Preliminary Clinical Activity of BT8009 in Patients With Nectin-4 Expressing Advanced Malignancies

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Record identity and dates

Source: ClinicalTrials.gov
Source record ID: NCT04561362
Title field or adapter rule: {'original_value': 'Phase I/II Study of the Safety, Pharmacokinetics, and Preliminary Clinical Activity of BT8009 in Patients With Nectin-4 Expressing Advanced Malignancies', 'source_field': 'protocolSection.identificationModule.officialTitle'}
Ingested At: 2026-10-31T23:27:30.567031+00:00
Published At: 2026-10-20T00:00:00+00:00
Record Updated At: 2026-10-20
Source Retrieved At: 2026-10-31T22:18:24.976182+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: ["Urinary Bladder Neoplasm", "Triple Negative Breast Neoplasms", "Hormone Receptor Positive, HER2-negative Neoplasms", "Hormone Receptor Positive, HER2-low Neoplasms", "Breast Neoplasms", "Non-Small-Cell Lung Neoplasms", "Ovarian Neoplasm", "Advanced Solid Tumor"]
protocolSection.statusModule.lastUpdatePostDateStruct: {"date": "2026-10-20", "type": "ACTUAL"}
protocolSection.identificationModule.nctId: "NCT04561362"
protocolSection.identificationModule.officialTitle: "Phase I/II Study of the Safety, Pharmacokinetics, and Preliminary Clinical Activity of BT8009 in Patients With Nectin-4 Expressing Advanced Malignancies"
protocolSection.statusModule.overallStatus: "ACTIVE_NOT_RECRUITING"
protocolSection.designModule.phases: ["PHASE1", "PHASE2"]
protocolSection.statusModule.resultsFirstPostDateStruct: null

Study condition terms

Interventions recorded in this study

{'armGroupLabels': ['Cohort B-1 - BT8009 Monotherapy Dose Expansion', 'Cohort B-2- BT8009 Monotherapy Dose Expansion', 'Cohort B-3- BT8009 Monotherapy Dose Expansion', 'Cohort B-4- BT8009 Monotherapy Dose Expansion', 'Cohort B-5- BT8009 Monotherapy Dose Expansion', 'Cohort B-6- BT8009 Monotherapy Dose Expansion', 'Cohort B-7- BT8009 in Combination with Pembrolizumab Dose Expansion', 'Part A-1 -BT8009 Monotherapy Dose Escalation', 'Part A-2 -BT8009 in Combination with Pembrolizumab Dose De-Escalation', 'Part B-8 - BT8009 Monotherapy Dose Expansion', 'Part B-9 - BT8009 Monotherapy Dose Expansion', 'Part C - Renal Insufficiency BT8009 Monotherapy Dose Expansion', 'Part D - BT8009 Monotherapy Supplementary PK'], 'description': 'Bicyclic Toxin Conjugate (BTC) administered either weekly (i.e., on Days 1, 8, 15, and 22) or biweekly (Days 1 and 15) on a 28-day cycle or on Days 1 and 8 of a 21-day cycle for participants in A-1. Participants in Cohorts A-2 and B-7 will receive BT8009 weekly on 21-day cycle. Participants in Parts B-1-B-6 will receive BT8009 weekly either on a 21-day or 28-day cycle. Participants in Parts B-8 and B-9 will receive BT8009 on Days 1 and 8 of a 21-day cycle. Participants in Cohort C will receive BT8009 once weekly (i.e., on Days 1, 8, 15, and 22) on a 28-day cycle. Participants in Part D will receive BT8009 once weekly on a 28-day cycle.', 'name': 'BT8009', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
{'armGroupLabels': ['Cohort B-7- BT8009 in Combination with Pembrolizumab Dose Expansion', 'Part A-2 -BT8009 in Combination with Pembrolizumab Dose De-Escalation'], 'description': 'Participants in Cohorts A-2 and B-7 will receive 200 mg IV over 30-minute infusion of pembrolizumab on Day 1 of each Q3W.', '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

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