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NCT04147819 · ClinicalTrials.gov registry record · Phase 1
A First in Human Study of BAY2701439 to Look at Safety, How the Body Absorbs, Distributes and Excretes the Drug, and How Well the Drug Works in Participants With Advanced Cancer Expressing the HER2 Protein
A Phase 1 study of Cancers With HER2 Expression, sponsored by Bayer.
- Completed
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
- 6
- Study locations
NCT04147819 is a Phase 1 study of Cancers With HER2 Expression that has completed, run by Bayer. The registered enrollment target is 14 participants. The trial reports 6 study locations across 6 states.
The verdict
NCT04147819, a Phase 1 study of Cancers With HER2 Expression, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
- 6
- Study locations
Study Summary
In this study, researchers want to learn about the safety of drug BAY2701439 and how well the drug works in patients with advanced cancer that has the protein HER2 (Human Epidermal growth factor Receptor 2) and cannot be cured by currently available treatment options. The study will include patients with HER2 expressing breast, gastric (stomach) or gastroesophageal (stomach and esophagus) cancer, as well as other cancers that have HER2. Researchers want to find the best dose of BAY2701439 for patients and look at the way the body absorbs, distributes and excretes the drug. The study drug is a type of therapy called a 'targeted alpha therapy' which uses an antibody to deliver a radioactive particle to cancer cells. BAY2701439 contains thorium-227 which emits radiation (a lot of energy that moves from one place to another with damaging effects). The thorium-227 in the drug is attached to an 'antibody' (large protein) that specifically binds to HER2 on the cancer cells and will emit its radiation in the form of alpha particles. The alpha particles are expected to damage the tumor cells and cause them to die, but spare surrounding tissue as alpha particles travel only very short distances in the body. This is the first study in humans for drug BAY2701439. Patients participating in this study will receive the drug by injection every 6 weeks a maximum 6 times. Observation after treatment last up to 3 years.
Conditions Studied
Interventions
- DRUG BAY2701439
Study Locations (6)
Maryland
- Johns Hopkins Hospital/Health System - Baltimore
Missouri
- Washington University School of Medicine - St Louis
New York
- Memorial Sloan-Kettering Cancer Center - New York
Texas
- University of Texas MD Anderson Cancer Center - Houston
Hampshire
- Southampton General Hospital - Southampton
Surrey
- Royal Marsden NHS Trust (Surrey) - Sutton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2020-07-02 |
| Est. Completion | 2023-09-26 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04147819
The ClinicalTrials.gov registry entry for NCT04147819 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Cancers With HER2 Expression appearing as the primary indexed condition, and to 1 intervention - of which BAY2701439 is the first listed.
NCT04147819 reports 6 study locations spanning 6 distinct geographic areas - top geographies include Maryland, Missouri, New York.
Frequently Asked Questions
What is clinical trial NCT04147819 about?
NCT04147819 is a clinical study titled "A First in Human Study of BAY2701439 to Look at Safety, How the Body Absorbs, Distributes and Excretes the Drug, and How Well the Drug Works in Participants With Advanced Cancer Expressing the HER2 Protein". In this study, researchers want to learn about the safety of drug BAY2701439 and how well the drug works in patients with advanced cancer that has the protein HER2 (Human Epidermal growth factor Receptor 2) and cannot be cured by currently available treatment options. The study will include patients...
What is the current status of trial NCT04147819?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2020-07-02. Estimated completion is 2023-09-26.
What conditions does trial NCT04147819 study?
This clinical trial studies the following conditions: Cancers With HER2 Expression.
What interventions are being tested in trial NCT04147819?
The interventions under investigation include: BAY2701439 (DRUG).
Who is sponsoring clinical trial NCT04147819?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04147819 being conducted?
This trial has 6 study locations across Maryland, Missouri, New York, Texas, Hampshire. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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