Hepatocellular Carcinoma (HCC)Phase 1NCT06345001
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
A Phase 1 study testing BAY3630942 and BAY3547922 in people with Hepatocellular Carcinoma (HCC) and Solid Tumors, run by Bayer at 4 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma (HCC), Solid Tumors
- What is being tested?
- BAY3630942 and BAY3547922
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 4 sitesUnited States
- Study dates
- 26 Aug 2024to 31 Mar 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
4 sites in 1 country.
United States4 sites
City of Hope - Duarte Cancer Center
Duarte, California, 91010
University of Southern California (USC) - Norris Comprehensive Cancer Center
Los Angeles, California, 90089-1019
Biogenix Molecular, LLC
Miami, Florida, 33165
HonorHealth Research Institute
Scottsdale, Arizona, 85258
About this study
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 or Other Select Solid Tumors.
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.
Read more
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:
- 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 or other select solid cancers, access to BAY3630942 and BAY3547922 after the end of the study will not be required.
- Conditions
- Hepatocellular Carcinoma (HCC), Solid Tumors
- Being tested
- BAY3630942, BAY3547922
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAY3630942Drug
IV, Single administration
BAY3547922Drug
IV, Single infusion
| Study group | Role | What they receive |
|---|---|---|
| Part 1 - Total mass dose selection | Experimental | Participants with HCC or other select solid tumors 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. Receives: Drug: BAY3630942; Drug: BAY3547922 |
| Part 2 - Actinium-225 Dosimetry Estimates | Experimental | Participants with HCC or other select solid tumors will receive the total mass dose level selected in Part 1. Receives: Drug: BAY3630942; Drug: BAY3547922 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 12 days
Zirconium-89 absorbed doses (mGy/MBq) in normal organs
Measured: Up to 12 days
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)
Measured: Up to 12 days
Secondary outcomes (5)
Proportion and severity of adverse events (AEs) after administration of BAY3630942 and BAY3547922
Measured: Up to 30 days
Cmax (from zirconium-89 radioactivity concentration (Bq/g and %ID/kg) as a function of time in blood)
Cmax: Maximum observed concentration
Measured: Up to 12 days
AUC (from zirconium-89 radioactivity concentration (Bq/g and %ID/kg) as a function of time in blood)
AUC: Area under the curve
Measured: Up to 12 days
Cmax (from plasma concentration of total antibody (mg/L and %ID/L) as a function of time)
Measured: Up to 12 days
AUC (from plasma concentration of total antibody (mg/L and %ID/L) as a function of time)
Measured: Up to 12 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start26 Aug 2024
- Primary completion10 Mar 2025
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06345001
- Sponsor's protocol ID
- 22261
- Status last verified
- Apr 2025
- First submitted
- 28 Mar 2024
- Last updated
- 13 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 or Other Select Solid Tumors.
- ClinicalTrials.gov ID
- NCT06345001
- Acronym / sponsor ID
- 22261
- Conditions
- Hepatocellular Carcinoma (HCC), Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 26 Aug 2024 (actual)
- Primary completion
- 10 Mar 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 3 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 or other select solid cancers, access to BAY3630942 and BAY3547922 after the end of the study will not be required.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1 - Total mass dose selection | Experimental | Drug: BAY3630942, Drug: BAY3547922Participants with HCC or other select solid tumors 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. |
| Part 2 - Actinium-225 Dosimetry Estimates | Experimental | Drug: BAY3630942, Drug: BAY3547922Participants with HCC or other select solid tumors will receive the total mass dose level selected in Part 1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BAY3630942IV, Single administration | Drug | Part 1 - Total mass dose selection, Part 2 - Actinium-225 Dosimetry Estimates |
| BAY3547922IV, Single infusion | Drug | Part 1 - Total mass dose selection, Part 2 - Actinium-225 Dosimetry Estimates |
Primary outcome
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
Time frame: Up to 12 days
Zirconium-89 absorbed doses (mGy/MBq) in normal organs
Time frame: Up to 12 days
Absorbed doses (mGy/MBq) from actinium-225 and daughter radionuclides in critical organs estimated
Time frame: Up to 12 days
By using the normal organ biodistribution time-course data of BAY3630942 (with assumptions on actinium-225 daughter radionuclides redistribution to critical organs)
5 secondary outcomes
Proportion and severity of adverse events (AEs) after administration of BAY3630942 and BAY3547922
Time frame: Up to 30 days
Cmax (from zirconium-89 radioactivity concentration (Bq/g and %ID/kg) as a function of time in blood)
Time frame: Up to 12 days
AUC (from zirconium-89 radioactivity concentration (Bq/g and %ID/kg) as a function of time in blood)
Time frame: Up to 12 days
Cmax (from plasma concentration of total antibody (mg/L and %ID/L) as a function of time)
Time frame: Up to 12 days
AUC (from plasma concentration of total antibody (mg/L and %ID/L) as a function of time)
Time frame: Up to 12 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2025.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BAY3630942 and BAY3547922 in people with Hepatocellular Carcinoma (HCC) and Solid Tumors, run by Bayer at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: Up to 12 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2025.