Clinical Trial

Study BT5528-100 in Patients With Advanced Solid Tumors Associated With EphA2 Expression

Active, Not Recruiting Phase 1/2
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Record status
This record was last updated November 17, 2025 (before its estimated July 31, 2026 completion). Its status may not reflect the trial's current state.
Summary
This clinical trial is evaluating a drug called BT5528 alone and in combination with nivolumab in participants with advanced solid tumors historically known for expression of EphA2. The main goals of this study are to: * Find the recommended dose(s) of BT5528 that can be given safely to participants alone and in combination with nivolumab * Learn more about the side effects of BT5528 * Learn about how effective BT5528 is for the treatment of ovarian cancer, urothelial/bladder cancer, lung cancer (NSCLC), triple-negative breast cancer, head and neck cancer (HNSCC), and gastric/upper gastrointestinal cancer. * Learn more about BT5528 therapy alone and in combination with nivolumab.
Protocol Amendment History 28 amendments
This ClinicalTrials.gov record has been amended 28 times since 2019-11-26; most recent amendment 2025-11-14.
Status change: Recruiting → Active, Not Recruiting 2025-11-14
Trial Details
NCT Number NCT04180371
Lead Sponsor BicycleTx Limited
Conditions Advanced Solid Tumor Historically Known for High EphA2 Expression, Urothelial Cancer, Ovarian Cancer, Non-small Cell Lung Cancer, Head and Neck Cancer, Triple Negative Breast Cancer, Gastric/Upper Gastrointestinal Cancer
Enrollment 288 participants
Start Date 2019-11-07
Primary Completion 2026-07-31 (estimated)
Study Completion 2027-07-31 (estimated)
Updated on ClinicalTrials.gov 2025-11-17