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NCT04180371 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Non-Small Cell Lung Cancer and Ovarian Cancer, sponsored by BicycleTx Limited.

Active
Registry status
Phase 1
Development phase
288
Enrollment target
20
Study locations

NCT04180371 is a Phase 1 study of Non-Small Cell Lung Cancer and Ovarian Cancer that is active but no longer recruiting, run by BicycleTx Limited. The registered enrollment target is 288 participants, below the 658-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (56% lower). The trial reports 20 study locations across 12 states.

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The verdict

NCT04180371, a Phase 1 study of Non-Small Cell Lung Cancer and Ovarian Cancer, is active but no longer recruiting, sponsored by BicycleTx Limited.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
288 participants
Enrollment target
20
Study locations

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

What the Registry Record Tells You About NCT04180371

The ClinicalTrials.gov registry entry for NCT04180371 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 288 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 658-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (56% lower). The listed sponsor is BicycleTx Limited, which has 7 total studies on file at ClinicalTrials.gov.

The record links to 7 conditions, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 2 interventions - of which Nivolumab is the first listed.

NCT04180371 reports 20 study locations spanning 12 distinct geographic areas - top geographies include Other, California, Colorado.

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: Non-Small Cell Lung Cancer, Ovarian Cancer, Head and Neck Cancer, Triple Negative Breast Cancer, Urothelial Cancer.

What interventions are being tested in trial NCT04180371?

The interventions under investigation include: Nivolumab (DRUG), BT5528 (DRUG).

Who is sponsoring clinical trial NCT04180371?

This trial is sponsored by BicycleTx Limited, which has 7 total clinical trials registered on ClinicalTrials.gov.

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.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.