BAY 3547926 for Liver Cancer

(BANTAM-01 Trial)

Recruiting at 27 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, BAY 3547926, for advanced hepatocellular carcinoma (HCC) with a specific protein marker, Glypican 3 (GPC3). The goal is to determine the safest and most effective dose of BAY 3547926, which uses radiation to target cancer cells while sparing healthy tissue. Participants will receive varying doses to assess how their bodies respond and the drug's effectiveness. The study seeks individuals whose liver cancer has not responded to surgery or other treatments and who have a GPC3-positive tumor. As a Phase 1 trial, participants will be among the first to receive this treatment, aiding researchers in understanding its effects in people.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team to get a clear answer.

Is there any evidence suggesting that BAY 3547926 is likely to be safe for humans?

Research shows that BAY 3547926 is undergoing its first human trials. This drug targets cancer cells by delivering a radioactive substance directly to them, aiming to minimize harm to nearby healthy tissues since the radiation doesn't travel far.

As this is the initial study in humans, specific information on how well people tolerate BAY 3547926 is not yet available. In these early stages, researchers focus on understanding its safety and determining the right dose. This phase is crucial for identifying any potential side effects and ensuring the treatment's safety for future use.

Participants in this study will have regular health check-ups and tests to closely monitor their health, helping to quickly identify and manage any side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for liver cancer, such as surgery, chemotherapy, or targeted therapies like sorafenib, BAY 3547926 is an innovative approach using an actinium-225 labeled antibody conjugate. This means it combines a radioactive element, actinium-225, with an antibody that specifically targets cancer cells, delivering radiation directly to the tumor while sparing healthy tissues. Researchers are excited about BAY 3547926 because this targeted delivery method could potentially lead to more effective tumor destruction with fewer side effects compared to traditional treatments.

What evidence suggests that BAY 3547926 might be an effective treatment for liver cancer?

Research has shown that BAY 3547926 is a new treatment targeting liver cancer cells with a protein called Glypican 3 (GPC3). This drug delivers a radioactive substance directly to the cancer cells, allowing the radiation to destroy them while causing less harm to nearby healthy cells. Early studies suggest that this targeted method could effectively slow tumor growth in liver cancer. However, as this is the first study in humans, more information is needed to confirm its effectiveness. Participants in this trial will receive BAY 3547926 to further evaluate its effectiveness and safety. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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).

How Is the Trial Designed?

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

Top Products

Aspirin, Aleve, Yaz, Nexavar

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

Citations

1. bayer.com bayer.com/en/us/news-stories/phase-i-study-hepatocellular-carcinoma

Bayer initiates Phase I study targeting GPC3 with actinium- ... BAY 3547926 is an investigational targeted alpha radiopharmaceutical being developed to treat tumors expressing Glypican-3 (GPC3) in patients ...

2. aacrjournals.org aacrjournals.org/cancerres/article/85/8_Supplement_2/ND09/762488/Abstract-ND09-BAY-3547926-Novel-targeted

Abstract ND09: BAY 3547926: Novel targeted radionuclide ... Ac-GPC3 is a novel GPC3 targeting high affinity antibody, conjugated with a macropa chelator for efficient and stable radiolabeling with 225Ac.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06345001

NCT06345001 | A First-in-Human Study to Learn About ... In this study, researchers want to understand the distribution and processing of this monoclonal antibody in people with liver cancer or other select solid ...

4. finance.yahoo.com finance.yahoo.com/news/bayer-initiates-phase-study-targeting-090000730.html

Bayer Initiates Phase I Study Targeting GPC3 With ... The first-in-human, dose escalation study (NCT06764316) will evaluate the safety, tolerability and preliminary efficacy of BAY 3547926 alone, ...

5. prnewswire.com prnewswire.com/news-releases/anti-gpc3-therapies-market-gains-traction-with-key-players-advancing-pipeline-for-hepatocellular-carcinoma-non-small-cell-lung-cancer-gastric-cancer-and-others--delveinsight-302502053.html

Anti-GPC3 Therapies Market Gains Traction with Key ... 225Ac-GPC3 (BAY 3547926) is an investigational alpha-emitting radiopharmaceutical aimed at treating advanced HCC tumors that express GPC3. It ...

6. ctv.veeva.com ctv.veeva.com/study/a-first-in-human-study-to-learn-about-the-safety-of-bay-3547926-and-how-well-it-works-in-participant

A First-in-human Study to Learn About the Safety of BAY ... 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.

7. clinicaltrial.be clinicaltrial.be/nl/details/523570?per_page=100&country=Belgium&recruiting=1&enrolling_by_invitation=0&active_not_recruiting=0&not_yet_recruiting=0&completed=0&only_recruiting=1&only_eligible=0

A First-in-human Study to Learn About the Safety of BAY 3... 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 ...