BAY 3547926 for Liver Cancer

Recruiting in Palo Alto (17 mi)

+22 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Bayer

Disqualifiers: Fibrolamellar HCC, CNS metastases, others

No Placebo Group

Trial Summary

What is the purpose of this trial?In this study, researchers want to learn about the safety of a new drug, BAY 3547926, and how well the drug works in people with a type of liver cancer called advanced hepatocellular carcinoma (HCC). Researchers want to find the best dose of BAY 3547926 for people with advanced HCC and look at the way the body absorbs and distributes the drug. The study drug, BAY 3547926, delivers a radioactive agent to cancer cells. The radioactive agent emits radiations which can damage the cancer cells and cause them to die. These radiations travel a small distance, so are expected to cause little damage to surrounding healthy tissues. This is the first study of BAY 3547926 in humans. Participants will take part in one of the 3 different parts of the study. In Part 1, participants will receive different doses of BAY 3547926 alone to find the dose that is deemed safe and works best for the participants. When this dose has been found, a larger number of participants will receive BAY 3547926 alone in Part 2 or with other treatments in Part 3 of the study. During the study, the doctors and their study team will do health check-ups, take pictures (scans) of the body, collect blood and urine samples, and ask participants questions about how they are feeling and what health problems they are having.

Eligibility Criteria

This trial is for individuals with advanced liver cancer, specifically hepatocellular carcinoma (HCC). Participants should be adults who have not responded to or cannot receive standard treatments. The study will exclude certain people based on additional medical criteria not specified here.

Inclusion Criteria

My bone marrow and organs are functioning well.

I have a tumor that can be measured by CT scan or MRI.

My liver cancer cannot be removed by surgery and is either locally advanced, has spread, or both.

+3 more

Exclusion Criteria

I have had brain metastases but meet specific treatment criteria.

I have a significant buildup of fluid in my abdomen.

I have not had severe brain function issues in the last year.

+1 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive different doses of BAY 3547926 to find the safe and effective dose

up to 36 weeks

Regular health check-ups, scans, and sample collections

Dose Expansion

Participants receive the determined safe dose of BAY 3547926 alone or in combination with other treatments

up to 60 months

Regular health check-ups, scans, and sample collections

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 60 months

Participant Groups

The trial is testing BAY 3547926, a new drug that delivers radiation directly to cancer cells in the liver. It's divided into three parts: finding a safe dose (Part 1), expanding the test at this dose (Part 2), and combining it with other treatments (Part 3).

1Treatment groups

Experimental Treatment

Group I: BAY 3547926Experimental Treatment2 Interventions

actinium-225 labeled antibody conjugate