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
- Diseases
- Liver and biliary tract cancer
- 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
Sites (31)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitair Ziekenhuis Antwerpen Coordinator of this site? Confirm its status | Edegem | Belgium | Recruiting |
| Algemeen Ziekenhuis Groeninge Coordinator of this site? Confirm its status | Kortrijk | Belgium | Recruiting |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Recruiting |
| Cliniques Universitaires Saint-Luc Coordinator of this site? Confirm its status | Sint-Lambrechts-Woluwe | Belgium | Recruiting |
| Edmonton Coordinator of this site? Confirm its status | Edmonton | Canada | Not yet recruiting |
| Montreal Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
| Sherbrooke Coordinator of this site? Confirm its status | Sherbrooke | Canada | Recruiting |
| Toronto Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| Fujian Coordinator of this site? Confirm its status | Fujian | China | Not yet recruiting |
| Wuhan Coordinator of this site? Confirm its status | Wuhan | China | Not yet recruiting |
| Xuhui District Coordinator of this site? Confirm its status | Xuhui | China | Recruiting |
| Institut Catala D'oncologia Coordinator of this site? Confirm its status | L'Hospitalet de Llobregat | Spain | Recruiting |
| Hospital Universitario HM Sanchinarro Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Clinica Universidad de Navarra Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Clínica Universidad de navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Recruiting |
| Tampere University Hospital Coordinator of this site? Confirm its status | Tampere | Finland | Recruiting |
| Turku University Hospital Coordinator of this site? Confirm its status | Turku | Finland | Recruiting |
| Hospices Civils de Lyon Coordinator of this site? Confirm its status | Bron | France | Recruiting |
| Institut Regional Du Cancer De Montpellier Coordinator of this site? Confirm its status | Montpellier Cedex 5 | France | Recruiting |
| Centre Hospitalier Universitaire de Nantes Coordinator of this site? Confirm its status | Nantes | France | Recruiting |
| CHRU De Nancy Coordinator of this site? Confirm its status | Vandoeuvre Les Nancy Cedex | France | Recruiting |
| Institut Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Recruiting |
| Glasgow Coordinator of this site? Confirm its status | Glasgow | United Kingdom | Recruiting |
| London Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Sutton Coordinator of this site? Confirm its status | Sutton | United Kingdom | Recruiting |
| Kashiwa Coordinator of this site? Confirm its status | Kashiwa | Japan | Recruiting |
| Tokyo Coordinator of this site? Confirm its status | Tokyo | Japan | Recruiting |
| Dothan Coordinator of this site? Confirm its status | Dothan | United States | Recruiting |
| Duarte Coordinator of this site? Confirm its status | Duarte | United States | Recruiting |
| Nashville Coordinator of this site? Confirm its status | Nashville | United States | Not yet recruiting |
| Orlando Coordinator of this site? Confirm its status | Orlando | United States | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.