New smart bomb for liver cancer: radiation drug targets tumors only
NCT ID NCT06764316
First seen Jun 27, 2026 · Last updated Aug 19, 2026 · Updated 8 times
Summary
This early-stage trial tests a new drug, BAY 3547926, that delivers radiation directly to liver cancer cells with a specific protein (GPC3). The goal is to find a safe dose and see if it shrinks tumors. About 148 adults with advanced liver cancer will take part in four groups, some receiving the drug alone and others in combination with other treatments.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- BAY 3547926 (a drug that delivers radiation directly to cancer cells)
- What this could lead to
- If it works, this could point toward a new treatment option for advanced liver cancer that targets cancer cells while sparing healthy tissue.
- What could go wrong
- This is a very early Phase 1 trial, so the drug may not be safe or effective. Only 148 people will take part, and results may not apply to everyone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 148 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2025
- Expected to finish
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Aug 2031
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
24 sites in 9 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Barcelona
RECRUITINGBarcelona, Barcelona, 08908, Spain
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Brussel
RECRUITINGBrussels, 1200, Belgium
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Dothan
RECRUITINGDothan, Alabama, 36303, United States
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Duarte
RECRUITINGDuarte, California, 91010, United States
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Edegem
RECRUITINGEdegem, Antwerp, 2650, Belgium
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Glasgow
RECRUITINGGlasgow, Scotland, G12 0YN, United Kingdom
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Kortrijk
RECRUITINGKortrijk, West Flanders, 8500, Belgium
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Leuven
RECRUITINGLeuven, Flemish Brabant, 3000, Belgium
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London
RECRUITINGLondon, Greater London, NW3 2QG, United Kingdom
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London
RECRUITINGLondon, Greater London, W12 0HS, United Kingdom
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Madrid
RECRUITINGMadrid, Madrid, 28050, Spain
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Madrid
RECRUITINGMadrid, 28027, Spain
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Montpellier
RECRUITINGMontpellier, Occitanie, 34298, France
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Montreal
RECRUITINGMontreal, Quebec, H2X 0C1, Canada
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Montreal
RECRUITINGMontreal, Quebec, H4A 3J1, Canada
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Pamplona
RECRUITINGPamplona, 31008, Spain
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Sherbrooke
RECRUITINGSherbrooke, Quebec, J1H 5N4, Canada
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Sutton
RECRUITINGSutton, Surrey, SM2 5PT, United Kingdom
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Tampere
RECRUITINGTampere, Pirkanmaa, 33520, Finland
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Tokyo
RECRUITINGTokyo, 104-0045, Japan
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Toronto
RECRUITINGToronto, Ontario, M5G 2C4, Canada
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Turku
RECRUITINGTurku, Southwest Finland, 20540, Finland
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Villejuif
RECRUITINGVillejuif, 94805, France
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Xuhui District
RECRUITINGXuhui, Shanghai Municipality, 200032, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- New antibody drug conjugate tested against advanced cancers
- Sparing the liver: targeted chemoembolization meets lenvatinib in liver cancer
- AI-Enhanced ultrasound aims to catch liver cancer earlier
- Can turbocharged immune cells stop liver cancer from coming back?
- Two blood markers put to the test for early liver cancer detection
- New antibody pair takes aim at advanced liver cancer in major trial