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Part 2 - Actinium-225 Dosimetry Estimates for Liver Cancer

Phase 1

Waitlist Available

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 30 days

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 30 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 30 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Absorbed doses (mGy/MBq) from actinium-225 and daughter radionuclides in critical organs estimated

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

Zirconium-89 absorbed doses (mGy/MBq) in normal organs

Secondary outcome measures

AUC (from plasma concentration of total antibody (mg/L and %ID/L) as a function of time)

AUC (from zirconium-89 radioactivity concentration (Bq/g and %ID/kg) as a function of time in blood)

Cmax (from plasma concentration of total antibody (mg/L and %ID/L) as a function of time)

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Part 2 - Actinium-225 Dosimetry EstimatesExperimental Treatment2 Interventions

Participants with HCC will receive the total mass dose level selected in Part 1.

Group II: Part 1 - Total mass dose selectionExperimental Treatment2 Interventions

Participants with HCC 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.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

BayerLead Sponsor

2,240 Previous Clinical Trials

25,332,760 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are researchers currently enrolling participants for this medical study?

"As per information from clinicaltrials.gov, this particular research endeavor is not currently in the process of enlisting participants. Despite being initially listed on 4/30/2024 and last updated on 4/2/2024, it is presently inactive in terms of patient recruitment. However, amidst a pool of 2669 active clinical trials, there are numerous other opportunities for individuals to participate at present."

Answered by AI

Has the FDA given their approval for Part 1 - Selection of the total mass dosage?

"In accordance with Power team's evaluation, the safety rating for Part 1 - Total mass dose selection is graded as a level 1 due to its Phase 1 trial status. This indicates that there exists limited evidence supporting both safety and effectiveness at this stage of clinical investigation."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06345001.

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