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Active, not recruiting Phase 1Phase 2 Interventional

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

ClinicalTrials.gov ID: NCT04180371

Public ClinicalTrials.gov record NCT04180371. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 25, 2026, 1:21 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Phase I/II Study of the Safety, Pharmacokinetics, and Preliminary Clinical Activity of BT5528 in Patients With Advanced Malignancies Associated With EphA2 Expression

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT04180371
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 1, Phase 2
Lead sponsor
BicycleTx Limited
Industry
Enrollment
288 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 7, 2019 (Actual)
Primary completion
Dec 31, 2026 (Estimated)
Completion
Jul 31, 2027 (Estimated)
Last update posted
Oct 16, 2026

2019 – 2027

United States locations

U.S. sites
12
U.S. states
11
U.S. cities
12
Facility City State ZIP Site status
California Cancer Associates for Research and Excellence, Inc. Encinitas California 92024 —
University of California - Irvine Medical Center Orange California 92868 —
Sarah Cannon Research Institute at HealthONE Denver Colorado 80218 —
Florida Cancer Specialists Sarasota Florida 34232 —
Barbara Ann Karmanos Cancer Institute Detroit Michigan 48201 —
Comprehensive Cancer Centers of Nevada Las Vegas Nevada 89169 —
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center New York New York 10021 —
Stephenson Cancer Center (Oklahoma University) Oklahoma City Oklahoma 73104 —
Sidney Kimmel Cancer Center at Thomas Jefferson University Philadelphia Pennsylvania 19107 —
Sarah Cannon and HCA Research Institute Nashville Tennessee 37221 —
MD Anderson Cancer Center Houston Texas 77030 —
Virginia Cancer Specialists Fairfax Virginia 22031 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 16 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04180371, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 16, 2026 · Synced Oct 25, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04180371 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →