RecruitingPhase IEN originalLiver cancerMetastatic / advanced

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

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This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the 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 4 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 Parts 3 and 4 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.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Pacjenci z zaawansowanym lub nieoperacyjnym rakiem wątroby (zwany rakiem zrazikowatokomórkowym, HCC), potwierdzonym badaniami.
  • Rak wątroby musi wykazywać obecność białka GPC3.
  • Choroba jest nieuleczalna operacyjnie lub postępuje mimo wcześniejszego leczenia.
  • Pacjent jest w dobrym stanie ogólnym, zdolny do samodzielnego poruszania się i dbania o siebie (ocena 0 lub 1 w skali ECOG).
  • W badaniach obrazowych (tomografia komputerowa, rezonans magnetyczny) widoczna jest przynajmniej jedna zmiana nowotworowa o określonych rozmiarach.
  • Prawidłowe wyniki badań krwi wskazujące na dobrą pracę szpiku kostnego i narządów.

✗ Disqualifies

  • Pacjenci z innymi typami raka wątroby niż rakowiak zrazikowatokomórkowy.
  • Pacjenci z przerzutami do mózgu, chyba że spełniają bardzo konkretne warunki.
  • Pacjenci, którzy w ciągu ostatniego roku mieli znaczące problemy z wątrobą powodujące zaburzenia świadomości.
  • Pacjenci z dużą ilością płynu w jamie brzusznej (wodobrzusze).

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
July 15, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (20)

Dothan

Dothan, United States

Duarte

Duarte, United States

Edegem

Edegem, Belgium

Leuven

Leuven, Belgium

Kortrijk

Kortrijk, Belgium

Toronto

Toronto, Canada

Montreal

Montreal, Canada

Montreal

Montreal, Canada

Sherbrooke

Sherbrooke, Canada

Xuhui District

Xuhui, China

Tampere

Tampere, Finland

Turku

Turku, Finland

Montpellier

Montpellier, France

L'Hospitalet de Llobregat

L'Hospitalet de Llobregat, Spain

Madrid

Madrid, Spain

Pamplona

Pamplona, Spain

London

London, United Kingdom

London

London, United Kingdom

Glasgow

Glasgow, United Kingdom

Sutton

Sutton, United Kingdom

Trial contact

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/3/2026.

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