Biogenix Molecular, LLC | Miami, FL
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 or Other Select Solid Cancers
Status and phase
Conditions
Treatments
Details and patient eligibility
About
Researchers are studying a new potential treatment for liver cancer or other select solid cancers.
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 cancer cells. This can help the new treatment to specifically target cancer cells.
In this study, researchers want to understand the distribution and processing of this monoclonal antibody in people with liver cancer or other select solid cancers.
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 or other select solid cancers 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:
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a visit up to 14 days before the start of the study to confirm if the participant can take part in the study.
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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.
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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 or other select solid cancers, access to BAY3630942 and BAY3547922 after the end of the study will not be required.
Enrollment
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Volunteers
Inclusion criteria
- Participant (male or female) must be 18 years of age inclusive, at the time of signing the informed consent.
- Histologically confirmed HCC or non-invasive diagnosis of HCC according to American Association for the Study of Liver Diseases (AASLD) criteria
- Histologically or cytologically confirmed solid tumors
- Child-Pugh class A and B7
- Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1
- Able to tolerate the study procedures, including 3 PET/CT scans
- Adequate bone marrow, hepatic, and renal function
- Agreed to take proper contraception measures
Exclusion criteria
- Impaired cardiac function or clinically significant cardiac disease (i.e., congestive heart failure New York Heart Association [NYHA] Class II, III or IV).
- Patients with arterial thrombotic or embolic events or venous pulmonary embolism within 3 months before the start of study intervention.
- On-going systemic anticancer therapy except continued luteinizing hormone-releasing hormone (LHRH) agonist or antagonists in participants with prostate adenocarcinoma
- Administered a radioisotope within 9 physical half-lives of that radioisotope (24 days for yttrium-90 or 90Y) before administration of the study interventions
- Any local or locoregional therapy of intrahepatic tumor lesions, open biopsy or significant traumatic injury < 4 weeks before administration of the study interventions.
- Known hypersensitivity to human monoclonal antibodies.
- Any condition which, in the opinion of the Investigator, would preclude participation in this study.
Trial design
Primary purpose
Allocation
Interventional model
Masking
14 participants in 2 patient groups
Trial contacts and locations
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Central trial contact
Bayer Clinical Trials Contact
Data sourced from clinicaltrials.gov
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