Clinical Trial

Study BT8009-100 in Subjects With Nectin-4 Expressing Advanced Malignancies

Active, Not Recruiting Phase 1/2
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Record status
This record was last updated November 14, 2025 (before its estimated March 2026 completion). Its status may not reflect the trial's current state.
Summary
This study is a Phase I/II, multicenter, first-in-human, open-label dose-escalation study of BT8009 given as a single agent and in combination with pembrolizumab in participants with advanced solid tumors associated with Nectin-4 expression or in participants with advanced solid tumor malignancies having renal insufficiency. The primary endpoints are: Dose limiting toxicities (Parts A-1 and A-2), Overall response rate per RECIST v1.1 (Parts B1-B7), Safety and tolerability (Parts B-8, B-9 and C), and characterization of the pharmacokinetics (Part D).
Protocol Amendment History 28 amendments
This ClinicalTrials.gov record has been amended 28 times since 2020-09-22; most recent amendment 2025-11-13.
Status change: Recruiting → Active, Not Recruiting 2025-11-13
Trial Details
NCT Number NCT04561362
Lead Sponsor BicycleTx Limited
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
Enrollment 329 participants
Start Date 2020-07-17
Primary Completion 2026-03 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2025-11-14