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

Hepatocellular Carcinoma (HCC) Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06345001
• Other study ID #: 22261
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: June 27, 2024
• Est. completion date: November 29, 2024

Study information

• Verified date: June 2024
• Source: Bayer
• Contact: Bayer Clinical Trials Contact
• Phone: (+)1-888-84 22937
• Email: clinical-trials-contact[@]bayer.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 17
• Est. completion date: November 29, 2024
• Est. primary completion date: November 12, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

• 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 anticancer therapy

• 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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma (HCC)

Intervention

Drug:
• BAY3630942
IV, Single administration
• BAY3547922
IV, Single infusion

Locations

Country	Name	City	State
United States	University of Southern California Keck School of Medicine	Los Angeles	California
United States	Biogenix Molecular, LLC	Miami	Florida
United States	HonorHealth	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		Up to 12 days
Primary	Zirconium-89 absorbed doses (mGy/MBq) in normal organs		Up to 12 days
Primary	Absorbed doses (mGy/MBq) from actinium-225 and daughter radionuclides in critical organs estimated	By using the normal organ biodistribution time-course data of BAY3630942 (with assumptions on actinium-225 daughter radionuclides redistribution to critical organs)	Up to 12 days
Secondary	Proportion and severity of adverse events (AEs) after administration of BAY3630942 and BAY3547922		Up to 30 days
Secondary	Cmax (from zirconium-89 radioactivity concentration (Bq/g and %ID/kg) as a function of time in blood)	Cmax: Maximum observed concentration	Up to 12 days
Secondary	AUC (from zirconium-89 radioactivity concentration (Bq/g and %ID/kg) as a function of time in blood)	AUC: Area under the curve	Up to 12 days
Secondary	Cmax (from plasma concentration of total antibody (mg/L and %ID/L) as a function of time)		Up to 12 days
Secondary	AUC (from plasma concentration of total antibody (mg/L and %ID/L) as a function of time)		Up to 12 days

External Links

•   Click here to find further information and, after study completion, the study results according to Bayer's transparency standards