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NCT06764316RecruitingPhase 1

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

A Multicenter, Open Label, Non-randomized First-in-human Phase 1 Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of BAY 3547926 Alone, and in Combination, in Participants With Advanced Hepatocellular Carcinoma (HCC)

Source: ClinicalTrials.gov · Last updated 21 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
148 (estimated)
First submitted
18 Dec 2024
Start date
28 Feb 2025
Primary completion date
31 Jul 2029
Lead sponsor
Bayer
NCT number
NCT06764316
EU CT number
2024-516615-25-00

What you commit to

  • Study type: Interventional · Phase 1
  • Planned participants: 148
  • From 28 Feb 2025 to the primary completion date, 31 Jul 2029
  • 31 sites in 9 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • History of encephalopathy ≥ Grade 2 within the past 12 months

Other

  • Fibrolamellar HCC, sarcomatoid HCC, and mixed hepatocellular/cholangiocarcinoma subtypes.
  • Participants with a history or clinical evidence of CNS metastases, unless they meet specific criteria
  • Clinically significant ascites

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (31)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Universitair Ziekenhuis Antwerpen
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EdegemBelgiumRecruiting
Algemeen Ziekenhuis Groeninge
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KortrijkBelgiumRecruiting
UZ Leuven
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LeuvenBelgiumRecruiting
Cliniques Universitaires Saint-Luc
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Sint-Lambrechts-WoluweBelgiumRecruiting
Edmonton
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EdmontonCanadaNot yet recruiting
Montreal
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MontrealCanadaRecruiting
Sherbrooke
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SherbrookeCanadaRecruiting
Toronto
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TorontoCanadaRecruiting
Fujian
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FujianChinaNot yet recruiting
Wuhan
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WuhanChinaNot yet recruiting
Xuhui District
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XuhuiChinaRecruiting
Institut Catala D'oncologia
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L'Hospitalet de LlobregatSpainRecruiting
Hospital Universitario HM Sanchinarro
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MadridSpainRecruiting
Clinica Universidad de Navarra
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MadridSpainRecruiting
Clínica Universidad de navarra
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PamplonaSpainRecruiting
Tampere University Hospital
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TampereFinlandRecruiting
Turku University Hospital
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TurkuFinlandRecruiting
Hospices Civils de Lyon
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BronFranceRecruiting
Institut Regional Du Cancer De Montpellier
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Montpellier Cedex 5FranceRecruiting
Centre Hospitalier Universitaire de Nantes
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NantesFranceRecruiting
CHRU De Nancy
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Vandoeuvre Les Nancy CedexFranceRecruiting
Institut Gustave Roussy
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VillejuifFranceRecruiting
Glasgow
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GlasgowUnited KingdomRecruiting
London
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LondonUnited KingdomRecruiting
Sutton
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SuttonUnited KingdomRecruiting
Kashiwa
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KashiwaJapanRecruiting
Tokyo
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TokyoJapanRecruiting
Dothan
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DothanUnited StatesRecruiting
Duarte
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DuarteUnited StatesRecruiting
Nashville
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NashvilleUnited StatesNot yet recruiting
Orlando
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OrlandoUnited StatesNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.