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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
NCT06345001 · View on ClinicalTrials.gov ↗
Study 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. 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 medica
Conditions Studied
Interventions
- DRUG BAY3630942
- DRUG BAY3547922
Study Locations (4)
California
- City of Hope - Duarte Cancer Center — Duarte
- University of Southern California (USC) - Norris Comprehensive Cancer Center — Los Angeles
Arizona
- HonorHealth Research Institute — Scottsdale
Florida
- Biogenix Molecular, LLC — Miami
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2024-08-26 |
| Est. Completion | 2025-03-31 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06345001
The ClinicalTrials.gov registry entry for NCT06345001 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bayer, which has 143 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Solid Tumors appearing as the primary indexed condition, and to 2 interventions — of which BAY3630942 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06345001 reports 4 study locations spanning 3 distinct geographic areas — top geographies include California, Arizona, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06345001 about?
NCT06345001 is a clinical study titled "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". 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 treatm...
What is the current status of trial NCT06345001?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2024-08-26. Estimated completion is 2025-03-31.
What conditions does trial NCT06345001 study?
This clinical trial studies the following conditions: Solid Tumors, Hepatocellular Carcinoma (HCC). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06345001?
The interventions under investigation include: BAY3630942 (DRUG), BAY3547922 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06345001?
This trial is sponsored by Bayer, which has 143 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06345001 being conducted?
This trial has 4 study locations across Arizona, California, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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