BAY 3547926 for Liver Cancer

(BANTAM-01 Trial)

Recruiting at 25 trial locations

Overseen By Bayer Clinical Trials Contact

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Bayer

Disqualifiers: Fibrolamellar HCC, CNS metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

148 Participants Needed

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), which has a special protein called Glypican 3 (GPC3). 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.

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.

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

Treatment Details

Interventions

• BAY 3547926

Trial Overview 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).

Participant Groups

Group I: BAY 3547926 Experimental Treatment 2 Interventions

actinium-225 labeled antibody conjugate

Who Is Running the Clinical Trial?

Bayer

Lead Sponsor

Trials

2,291

Recruited

25,560,000+

Founded

1863

Headquarters

Leverkusen, Germany

Known For

Pharmaceutical Innovations

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Bill Anderson

Bayer

Chief Executive Officer since 2023

BSc in Chemical Engineering from the University of Texas, MSc in Chemical Engineering and Management from MIT

Michael Devoy

Bayer

Chief Medical Officer since 2014

MD, PhD