Testing a new drug for advanced liver cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the safety and effectiveness of a new drug called BAY 3547926 in patients with advanced hepatocellular carcinoma (HCC) that expresses a specific protein known as Glypican 3 (GPC3). Participants will receive varying doses of the drug to determine the optimal dose that is both safe and effective. The drug works by delivering a radioactive agent directly to cancer cells, which is designed to minimize damage to surrounding healthy tissues. This is the first time BAY 3547926 is being tested in humans, making it a crucial step in understanding its potential benefits for treating advanced liver cancer.

Why it matters

Who can join: the full rules

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

Where it's running

• Dothan
  Dothan, Alabama, United States Recruiting
• Duarte
  Duarte, California, United States Recruiting
• Edegem
  Edegem, Antwerp, Belgium Recruiting
• Leuven
  Leuven, Flemish Brabant, Belgium Recruiting
• Kortrijk
  Kortrijk, West Flanders, Belgium Recruiting
• Brussel
  Brussels, Belgium Recruiting

Study contacts

• Study coordinator: Bayer Clinical Trials Contact
• Email: clinical-trials-contact@bayer.com
• Phone: (+)1-888-84 22937

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.