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BAY3630942 After BAY3547922 for Liver Cancer

Phase 1
Recruiting
Research Sponsored by Bayer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 days
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new potential treatment for liver cancer using a protein called a monoclonal antibody. The researchers want to see how well the antibody can target liver cancer cells and how it moves through

Who is the study for?
This trial is for individuals with liver cancer. Participants will receive two monoclonal antibodies, one with a tracer (BAY3630942) and one without (BAY3547922), to study how they distribute in the body. The goal is not treatment but to inform future dose selection.
What is being tested?
Researchers are testing BAY3630942 and BAY3547922 in people with liver cancer to understand their distribution within the body using PET/CT imaging. This first-in-human study aims to track these substances and assess safety over approximately 44 days.
What are the potential side effects?
Potential side effects include medical problems or adverse events related to receiving the monoclonal antibodies, which will be monitored by doctors throughout the study period.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Absorbed doses (mGy/MBq) from actinium-225 and daughter radionuclides in critical organs estimated
Secondary study objectives
AUC (from zirconium-89 radioactivity concentration (Bq/g and %ID/kg) as a function of time in blood)
Cmax (from zirconium-89 radioactivity concentration (Bq/g and %ID/kg) as a function of time in blood)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Part 2 - Actinium-225 Dosimetry EstimatesExperimental Treatment2 Interventions
Participants with HCC or other select solid tumors will receive the total mass dose level selected in Part 1.
Group II: Part 1 - Total mass dose selectionExperimental Treatment2 Interventions
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.

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Who is running the clinical trial?

BayerLead Sponsor
2,274 Previous Clinical Trials
25,532,634 Total Patients Enrolled
~8 spots leftby Jan 2025
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