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NCT06345001 · ClinicalTrials.gov registry record · Phase 1

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 of Solid Tumors and Hepatocellular Carcinoma (HCC), sponsored by Bayer.

Completed
Registry status
Phase 1
Development phase
14
Enrollment target
4
Study locations

NCT06345001: Completed Phase 1 study of Solid Tumors and Hepatocellular Carcinoma (HCC), sponsored by Bayer.

NCT06345001 is a Phase 1 study of Solid Tumors and Hepatocellular Carcinoma (HCC) that has completed, run by Bayer. The registered enrollment target is 14 participants, below the 284-participant average among 125 other Solid Tumors trials with a reported enrollment target (95% lower). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06345001, a Phase 1 study of Solid Tumors and Hepatocellular Carcinoma (HCC), has completed, sponsored by Bayer.

COMPLETED
Registry status
Phase 1
Development phase
14 participants
Enrollment target
4
Study locations

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

Solid Tumors Hepatocellular Carcinoma (HCC)

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

FieldValue
Enrollment Target 14 participants
Start Date 2024-08-26
Est. Completion 2025-03-31
Phase Phase 1
Bayer

591 total trials

What the finished NCT06345001 record still lists

NCT06345001 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 284-participant average among 125 other Solid Tumors trials with a reported enrollment target (95% lower).

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.

NCT06345001 reports a single indexed study location in California, Arizona, Florida.

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).

What interventions are being tested in trial NCT06345001?

The interventions under investigation include: BAY3630942 (DRUG), BAY3547922 (DRUG).

Who is sponsoring clinical trial NCT06345001?

This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.

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.

Learn More About Clinical Trials

Similar trials for Solid Tumors

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06345001's enrollment target sits among peer trials

14 120th of 125 higher than 5 of 125 other Solid Tumors trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Solid Tumors trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT06345001, the US trial registry maintained by the National Library of Medicine. NCT06345001 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.