BAY3630942 After BAY3547922 for Liver Cancer

No longer recruiting at 6 trial locations

Overseen By Bayer Clinical Trials Contact

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Bayer

Must be taking: LHRH agonists

Must not be taking: Systemic anticancer therapy

Disqualifiers: Cardiac disease, Thrombotic events, others

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

Compensation: Varies

Number of Visits: 7

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to treat liver cancer and other select solid cancers using a monoclonal antibody. Researchers aim to understand how this protein spreads and processes in the body when administered to patients. Participants will receive two forms of this monoclonal antibody: one with a tracer for tracking through imaging tests, and one without. Individuals diagnosed with liver cancer or certain other solid tumors who can undergo imaging tests like PET/CT scans may qualify for this trial. The study aims to gather information that could aid in developing a new cancer treatment. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this innovative therapy.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot be on ongoing systemic anticancer therapy, except for certain prostate cancer treatments.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research is currently investigating the safety of two new treatments, BAY3630942 and BAY3547922, which are types of monoclonal antibodies. These treatments have not been tested in humans before, so the study aims to determine their safety. The study also examines how these antibodies move through the body and how different organs process them.

As an early-stage study, the primary goal is to understand how the treatment functions in the body, rather than to treat cancer directly. Participants will receive both antibodies, and researchers will closely monitor their health for any medical issues, such as side effects or reactions.

Since this is the first human trial for these treatments, safety information is limited. However, early-stage trials are carefully designed to assess how well people can tolerate the treatment. Participants will not receive direct health benefits from the treatment, but their involvement will aid researchers in developing potential new therapies for liver cancer and other cancers in the future. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for liver cancer, which often include surgery, chemotherapy, and targeted therapies like sorafenib, BAY3547922 and BAY3630942 offer a unique approach. Researchers are excited about these treatments because they involve a novel mechanism using targeted radiotherapy. BAY3547922 is administered first to guide the treatment, followed by BAY3630942, which uses the radioactive isotope Actinium-225 to deliver targeted radiation directly to cancer cells. This method aims to provide a more precise attack on tumors, potentially reducing side effects and improving outcomes compared to traditional therapies.

What evidence suggests that this trial's treatments could be effective for liver cancer?

Research has shown that monoclonal antibodies, such as BAY3630942 and BAY3547922, can specifically target cancer cells by attaching to proteins on their surface. This targeting focuses treatment on cancer cells while sparing healthy cells. In this trial, participants will receive BAY3630942 following BAY3547922 to study how the body processes these antibodies. Although this study does not aim to provide a direct treatment benefit, the knowledge gained could guide future treatments. Early results from similar studies have shown that these antibodies are generally safe and may improve outcomes for patients with certain cancers. More research and data from future trials are needed to determine their effectiveness in treating liver cancer or other solid tumors. ^{1 3 4 5 6}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My liver cancer diagnosis is confirmed by lab tests or meets specific criteria.

Able to tolerate the study procedures, including 3 PET/CT scans

Agreed to take proper contraception measures

Exclusion Criteria

I do not have serious heart problems like heart failure.

Any condition which, in the opinion of the Investigator, would preclude participation in this study

I haven't had a treatment with a radioisotope like yttrium-90 within the last 24 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Imaging Intervention

Participants receive BAY3547922 and BAY3630942, followed by imaging and blood tests

12 days

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• BAY3547922
• BAY3630942

Trial Overview 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.

How Is the Trial Designed?

Group I: Part 2 - Actinium-225 Dosimetry Estimates Experimental Treatment 2 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 selection Experimental Treatment 2 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.

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

Published Research Related to This Trial

A meta-analysis of 2,213 subjects from 14 trials revealed that regorafenib, an oral multi-kinase inhibitor, significantly increases the risk of hepatic toxicities, with notable elevations in liver enzymes such as AST (32% incidence) and ALT (27% incidence).

Patients treated with regorafenib showed a high-grade risk of bilirubin elevation (5%) and AST elevation (6%), indicating the need for regular monitoring of liver function during treatment to manage potential adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incidence and risk of regorafenib-induced hepatotoxicity. Zhao, B., Zhao, H.[2019]

A retrospective analysis of adverse events related to PD-1/PD-L1 inhibitors revealed a significant association between Pembrolizumab and hepatitis B reactivation (HBVr), with a reporting odds ratio of 2.32, indicating a higher risk compared to other treatments.

No cases of HBVr were reported with Ipilimumab or Avelumab, suggesting that not all immune checkpoint inhibitors carry the same risk, highlighting the need for further prospective studies to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hepatitis B Virus Reactivation in Cancer Patients Treated With Immune Checkpoint Inhibitors. Burns, EA., Muhsen, IN., Anand, K., et al.[2023]

Regorafenib significantly improves overall survival in patients with advanced hepatocellular carcinoma (HCC) who have previously been treated with sorafenib, with a median overall survival of 10.6 months compared to 7.8 months for placebo, based on a randomized trial involving these patients.

The drug also shows a notable improvement in progression-free survival (3.1 months for regorafenib vs. 1.5 months for placebo) and has an acceptable safety profile, making it a promising new standard of care for this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefit-Risk Summary of Regorafenib for the Treatment of Patients with Advanced Hepatocellular Carcinoma That Has Progressed on Sorafenib. Pelosof, L., Lemery, S., Casak, S., et al.[2019]

Regorafenib has demonstrated a median overall survival of 11.08 months in hepatocellular carcinoma patients who have failed sorafenib treatment, based on a meta-analysis of 809 patients from one randomized-controlled trial and seven non-randomized studies.

The treatment shows a disease control rate of 65.5% and is considered relatively safe, with common side effects including diarrhea, fatigue, and hand-foot skin reactions, making it a valuable option for patients with intermediate to advanced stages of the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Regorafenib in Hepatocellular Carcinoma Patients: A Systematic Review and Meta-Analysis. Facciorusso, A., Abd El Aziz, MA., Sacco, R.[2023]

Hepatitis B reactivation can occur in patients undergoing cytotoxic chemotherapy, including those treated with everolimus, leading to severe liver complications, as illustrated by a fatal case in a woman with metastatic breast cancer.

It is crucial for clinicians to screen for hepatitis B and consider prophylactic antiviral treatment before starting everolimus, as this rare but serious complication can arise even in patients with resolved or inactive hepatitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fatal hepatitis B reactivation due to everolimus in metastatic breast cancer: case report and review of literature. Teplinsky, E., Cheung, D., Weisberg, I., et al.[2015]

Citations

1. clinicaltrials.bayer.com clinicaltrials.bayer.com/study/22261

Hepatocellular carcinoma (HCC) || Solid tumors 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 ...

2. withpower.com withpower.com/trial/phase-1-hepatocellular-carcinoma-3-2024-18bba

BAY3630942 After BAY3547922 for Liver Cancer Regorafenib has demonstrated a median overall survival of 11.08 months in hepatocellular carcinoma patients who have failed sorafenib treatment, based on a ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11543349/

Therapeutic advances in hepatocellular carcinoma The treatment exhibited a manageable safety profile, with an ORR of 50% and a median PFS of 4.27 months. These preliminary results indicate ...

4. clinicaltrials.bayer.com clinicaltrials.bayer.com/study/22262

hepatocellular carcinoma | Study 22262 A first-in-human study to learn about the safety of BAY 3547926 and how well it works in participants with advanced liver cancer.

5. ctv.veeva.com ctv.veeva.com/study/a-first-in-human-study-to-learn-about-how-bay3630942-is-distributed-and-processed-inside-the-body-wh

A First-in-Human Study to Learn About How BAY3630942 is ... In this study, participants will not derive therapeutic benefit from receiving BAY3630942 or BAY3547922. However, this study may help ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06345001

NCT06345001 | A First-in-Human Study to Learn About ... In this study, participants will not derive therapeutic benefit from receiving BAY3630942 or BAY3547922. However, this study may help researchers develop a new ...