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A First-in-human Study to Learn About the Safety of BAY 3547926 and How Well it Works in Participants With Advanced Liver Cancer

RecruitingPhase 1Ages 18 Years - anyAllBayer
NCT06764316 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 4 different parts of the study. In Part 1, participants will receive different doses of BAY 3547926 alone to find the dose

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📋 Eligibility rules (as published)
Inclusion Criteria: * Locally advanced or metastatic and/or unresectable HCC (hepatocellular carcinoma) with histological or cytological confirmation, or non-invasive diagnosis as per American Association for the Study of Liver Diseases (AASLD) criteria in participants with a confirmed diagnosis of cirrhosis. * Demonstrated positive centrally confirmed GPC3 expression by immunohistochemistry (IHC) on tumor sample. * Disease not amenable to, or progressive disease after, curative surgery and/or locoregional therapies of established efficacy such as resection, local ablation, chemoembolization. * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1. * At least one measurable lesion by computed tomography (CT) scan or magnetic resonance imaging (MRI) according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1. as assessed by local site Investigator within 28 days prior to the start of the study treatment. * Adequate bone marrow and organ function Exclusion Criteria: * Fibrolamellar HCC, sarcomatoid HCC, and mixed hepatocellular/cholangiocarcinoma subtypes. * Participants with a history or clinical evidence of CNS metastases, unless they meet specific criteria * History of encephalopathy ≥ Grade 2 within the past 12 months * Clinically significant ascites
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What it tests

  • BAY 3547926
  • BAY 3547922
  • BAY 3713391
  • BAY 3713389
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Where

36 sites
Dothan
Dothan, United States
Duarte
Duarte, United States
Orlando
Orlando, United States
Nashville
Nashville, United States
Edegem
Edegem, Belgium
Leuven
Leuven, Belgium
Kortrijk
Kortrijk, Belgium
Brussel
Brussels, Belgium

…and 28 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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