Neoplasms

All Conditions

Digestive System Diseases

Carcinoma

Carcinoma, Hepatocellular

Liver Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

All Drugs and Chemicals

Hematinics

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Liver Extracts

Chelating Agents

Participants with HCC will receive a single dose of BAY3630942 after intravenous (IV) administration of a specified dose of BAY3547922. Up to 5 total mass dose levels may be tested.

Participants with HCC will receive the total mass dose level selected in Part 1.

BAY3630942

BAY3547922

Bayer Clinical Trials Contact

Researchers are studying a new potential treatment for liver cancer.

To do this, researchers have developed a protein, called a monoclonal antibody, which can find and attach itself to another protein present on the surface of liver cancer cells. This can help the new treatment to specifically target cancer cells in the liver.

In this study, researchers want to understand the distribution and processing of this monoclonal antibody in people with liver cancer.

Researchers will use the following two forms of monoclonal antibody as study interventions during this study:

* BAY3630942: This is the monoclonal antibody attached to a tracer. A tracer emits radiation that can help researchers track the monoclonal antibody in the body using imaging tests like PET/CT (positron emission tomography / computed tomography). All participants will receive a fixed dose of BAY3630942 during the study.
* BAY3547922: This is the monoclonal antibody without the tracer. Participants may receive different amounts of BAY3547922 during the study.

In this study, participants will not derive therapeutic benefit from receiving BAY3630942 or BAY3547922. However, this study may help researchers develop a new treatment for people with liver cancer and find a dose to be tested in future studies.

The main purpose of this first-in-human study is to check how BAY3630942 distributes among different organs in the body and how much of the radiation it emits is absorbed by the organs based on the total dose of BAY3630942 and BAY3547922 given. For this, the researchers will:

* measure the amount of BAY3630942 radiation found in different organs over time.
* measure the amount of BAY3630942 radiation absorbed by different organs.
* use the above information to estimate the amount of radiation that would be absorbed by the same organs from the new potential treatment.

Researchers will also monitor the number and severity of medical problems participants have after receiving BAY3630942 and BAY3547922. These medical problems are also known as "adverse events". Doctors keep track of all medical problems that happen in studies, even if they do not think they might be related to the study interventions.

The study participants will first receive BAY3547922 as an infusion into a vein followed by BAY3630942 as an injection into the same vein. Both interventions will be administered only once, on the same day.

Each participant will be in the study for around 44 days with up to 7 visits to the study clinic which includes:

* a visit up to 14 days before the start of the study to confirm if the participant can take part in the study.
* up to 5 visits during the imaging intervention period. During this period, participants:

  * will receive the study interventions and have blood tests on the first visit,
  * will have imaging and blood tests on the next 3 visits. The tests scheduled for the second visit may be performed during the first visit.
  * may have blood tests on the last visit.
* a follow-up visit to check their health after 30 days of receiving the study interventions.

During the study, the doctors and their study team will:

* check participants' health by performing tests such as blood and urine tests, and check heart health using an electrocardiogram (ECG)
* track and study BAY3630942 using PET/CT imaging tests

As the study interventions are not yet treatments for liver cancer, access to BAY3630942 and BAY3547922 after the end of the study will not be required.

A First-in-Human Study to Learn About How BAY3630942 is Distributed and Processed Inside the Body When Given After BAY3547922 and How Safe it is in People With Liver Cancer

An Open-label Phase 1 Imaging Study to Evaluate the Biodistribution, Dosimetry, Safety and Pharmacokinetics of BAY 3630942, a 89Zr-labeled Monoclonal Antibody, With a Pre-infusion of BAY 3547922, a Monoclonal Antibody-chelator Conjugate, in Patients With Hepatocellular Carcinoma.

Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

By using the normal organ biodistribution time-course data of BAY3630942 (with assumptions on actinium-225 daughter radionuclides redistribution to critical organs)

Bayer

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A First-in-Human Study to Learn About How BAY3630942 is Distributed and Processed Inside the Body When Given After BAY3547922 and How Safe it is in People With Liver Cancer	NCT06345001	Hepatocellular ...	BAY3630942 BAY3547922	18 Years -	Bayer
A First-in-Human Study to Learn About How BAY3630942 is Distributed and Processed Inside the Body When Given After BAY3547922 and How Safe it is in People With Liver Cancer	NCT06345001	Hepatocellular ...	BAY3630942 BAY3547922	18 Years -	Bayer

Spots Global Cancer Trial Database for bay3630942

Every month we try and update this database with for bay3630942 cancer trials from around the world to help patients and their families find trials that might be right for them.
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Spots Global Cancer Trial Database for bay3630942

Every month we try and update this database with for bay3630942 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for bay3630942 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.