Clinical trialNCT04180371Active, not recruitingPhase 1/PHASE2Interventional

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

SponsorBicycleTx LimitedEnrollment288Advanced Solid Tumor Historically Known for High EphA2 ExpressionGastric/Upper Gastrointestinal CancerHead and Neck CancerNon-small Cell Lung CancerOvarian CancerTriple Negative Breast Cancer+1 more conditions

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Meredith McKean, MD, MPH
Sarah Cannon and HCA Research Institute
Study Chair
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A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

28 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Belgium

Cliniques Universitaires Saint-Luc
Brussels, Belgium
Institut Jules Bordet
Brussels, Belgium
Antwerp University Hospital (uza)
Edegem, Belgium
Universitair Ziekenhuis Gent (uz)
Ghent, Belgium

South Korea

Gachon University Gil Medical Center
Incheon, South Korea
Severance Hospital, Yonsei University Health System
Seoul, South Korea

Spain

Hospital Universitario Vall D'Hebron
Barcelona, Spain
Institut Catala D'Oncologia - L'Hospitalet
Barcelona, Spain
Centro Integral Oncologico Clara Campal
Madrid, Spain
Hospital Fundación Jimenez Diaz
Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain

United Kingdom

Sarah Cannon Research Institute Uk
London, United Kingdom, United Kingdom
the Christie Nhs Foundation Trust
Manchester, United Kingdom, United Kingdom
Cambridge University Hospitals Nhs Foundation Trust
Cambridge, United Kingdom
the Leeds Teaching Hospitals Nhs Trust of Trust Headquarters, St James'S University Hospital
Leeds, United Kingdom
Sir Bobby Robson Cancer Trials Research Centre, the Northern Center for Cancer Care, Freeman Hospital
Newcastle upon Tyne, United Kingdom

United States

California Cancer Associates for Research and Excellence, Inc.
Encinitas, California, United States
University of California - Irvine Medical Center
Orange, California, United States
Sarah Cannon Research Institute at Healthone
Denver, Colorado, United States
Florida Cancer Specialists
Sarasota, Florida, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
New York, New York, United States
Stephenson Cancer Center (oklahoma University)
Oklahoma City, Oklahoma, United States
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Sarah Cannon and Hca Research Institute
Nashville, Tennessee, United States
Md Anderson Cancer Center
Houston, Texas, United States
Virginia Cancer Specialists
Fairfax, Virginia, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

BT5528Nivolumab →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 7 Nov 2019
Primary completion: 31 Jul 2026
Completion: 31 Jul 2027
Last update posted: 17 Nov 2025
Registered enrollment: 288
Registry id: NCT04180371

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.