protocolSection identificationModule nctId: NCT06345001, orgStudyIdInfo id: 22261, briefTitle: 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, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2024-08-12, completionDateStruct date: 2024-08-30, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Bayer, class: INDUSTRY, descriptionModule briefSummary: 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 testsAs 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., conditionsModule conditions: Hepatocellular Carcinoma (HCC), designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 17, type: ESTIMATED, armsInterventionsModule interventions name: BAY3630942, interventions name: BAY3547922, outcomesModule primaryOutcomes measure: Radioactivity concentration (SUVmean, %ID/g) of BAY3630942 in normal organs (including but not limited to kidney, spleen, liver, and bone marrow) as a function of time using 3 post-administration PET/CT scans, primaryOutcomes measure: Zirconium-89 absorbed doses (mGy/MBq) in normal organs, primaryOutcomes measure: Absorbed doses (mGy/MBq) from actinium-225 and daughter radionuclides in critical organs estimated, secondaryOutcomes measure: Proportion and severity of adverse events (AEs) after administration of BAY3630942 and BAY3547922, secondaryOutcomes measure: Cmax (from zirconium-89 radioactivity concentration (Bq/g and %ID/kg) as a function of time in blood), secondaryOutcomes measure: AUC (from zirconium-89 radioactivity concentration (Bq/g and %ID/kg) as a function of time in blood), secondaryOutcomes measure: Cmax (from plasma concentration of total antibody (mg/L and %ID/L) as a function of time), secondaryOutcomes measure: AUC (from plasma concentration of total antibody (mg/L and %ID/L) as a function of time), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: HonorHealth, city: Scottsdale, state: Arizona, zip: 85258, country: United States, geoPoint lat: 33.50921, lon: -111.89903, locations facility: University of Southern California Keck School of Medicine, city: Los Angeles, state: California, zip: 90089, country: United States, geoPoint lat: 34.05223, lon: -118.24368, locations facility: Biogenix Molecular, LLC, city: Miami, state: Florida, zip: 33165, country: United States, geoPoint lat: 25.77427, lon: -80.19366, hasResults: False