A Phase 1 Open-label, First-in-human, Multi-center Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of Thorium-227 Labeled Antibody-chelator Conjugate BAY2701439, in Participants With Advanced HER2-expressing Tumors
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.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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