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ACTIVE NOT RECRUITING Phase 1

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

NCT04180371 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • DRUG Nivolumab
  • DRUG BT5528

Study Locations (20)

Other

  • Institut Jules Bordet — Brussels
  • Cliniques Universitaires Saint-Luc — Brussels
  • Antwerp University Hospital (UZA) — Edegem
  • Universitair Ziekenhuis Gent (UZ) — Ghent
  • Gachon University Gil Medical Center — Incheon
  • Severance Hospital, Yonsei University Health System — Seoul
  • Institut Catala d'Oncologia - L'Hospitalet — Barcelona
  • Hospital Universitario Vall d'Hebron — Barcelona

California

  • California Cancer Associates for Research and Excellence, Inc. — Encinitas
  • University of California - Irvine Medical Center — Orange

Colorado

  • Sarah Cannon Research Institute at HealthONE — Denver

Florida

  • Florida Cancer Specialists — Sarasota

Michigan

  • Barbara Ann Karmanos Cancer Institute — Detroit

Nevada

  • Comprehensive Cancer Centers of Nevada — Las Vegas

New York

  • David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center — New York

Oklahoma

  • Stephenson Cancer Center (Oklahoma University) — Oklahoma City

Trial Details

FieldValue
Enrollment Target 288 participants
Start Date 2019-11-07
Est. Completion 2027-07-31
Phase Phase 1

Sponsor

BicycleTx Limited

7 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04180371

The ClinicalTrials.gov registry entry for NCT04180371 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 288 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is BicycleTx Limited, which has 7 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 7 conditions, with Ovarian Cancer appearing as the primary indexed condition, and to 2 interventions — of which Nivolumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04180371 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Other, California, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04180371 about?

NCT04180371 is a clinical study titled "Study BT5528-100 in Patients With Advanced Solid Tumors Associated With EphA2 Expression". 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 participant...

What is the current status of trial NCT04180371?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 288 participants. The study started on 2019-11-07. Estimated completion is 2027-07-31.

What conditions does trial NCT04180371 study?

This clinical trial studies the following conditions: Ovarian Cancer, Head and Neck Cancer, Non-small Cell Lung Cancer, Triple Negative Breast Cancer, Urothelial Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04180371?

The interventions under investigation include: Nivolumab (DRUG), BT5528 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04180371?

This trial is sponsored by BicycleTx Limited, which has 7 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04180371 being conducted?

This trial has 20 study locations across California, Colorado, Florida, Michigan, Nevada. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial