At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- BAY 3547926 (drug), BAY 3547922 (drug), BAY 3713391 (drug), BAY 3713389 (drug)
- How long the study runs
- Study runs about 78 months (dates as stated)
- About the drug or intervention
- BAY 3547926 — drug: antibody conjugate with actinium-225 label · BAY 3547922 — drug: antibody conjugate without actinium-225 label as preinjection · BAY 3713391 — drug: Radioactive imaging agent - optional preinjection · BAY 3713389 — drug: optional preinjection
- Patient visit burden
- Not specified by the sponsor
In plain English
This is a first-in-human study looking at whether a new drug called BAY 3547926 is safe and how well it works in people with advanced liver cancer (hepatocellular carcinoma). It is funded by Bayer.
Who can take part
- Advanced or spread-out liver cancer that cannot be removed by surgery, confirmed by tests or by scans in people with cirrhosis
- The cancer must show a protein called GPC3, checked on a tumour sample
- The disease cannot be treated with curative surgery or local treatments such as ablation or chemoembolisation, or has got worse after them
- Being able to carry out normal daily activities (performance status score of 0 or 1)
- At least one tumour that can be measured on a CT or MRI scan within 28 days before starting treatment
- Good enough bone marrow and organ function
Who may not be able to
- Certain rarer types of liver cancer (fibrolamellar, sarcomatoid, or mixed hepatocellular/cholangiocarcinoma)
- Cancer that has spread to the brain or spinal cord, unless specific conditions are met
- A history of confusion or brain symptoms (encephalopathy) of grade 2 or worse in the past 12 months
- Fluid build-up in the tummy (ascites) that is clinically significant
What taking part involves
- • Not stated — ask the trial team
Time commitment: Not stated — ask the trial team about how many visits, how long the study lasts, and what taking part involves.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 148
- Started
- 2025-02-28
- Last checked
- 2026-07
Plain English Summary
What is this study?
- • Testing a new treatment for hepatocellular carcinoma
- • Phase1 - 148 participants
- • 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)
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with hepatocellular carcinoma
Where?
- • London - London
- • London - London
- • Glasgow - Glasgow
- • Sutton - Sutton
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This 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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓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...
- ✓activity scale (ECOG) Performance Status (PS) of 0 or 1.
- ✓Adequate bone marrow and organ health
Who cannot take part
- ✗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
See the full criteria
Where Is This Study? (4 UK sites)
London
London NW3 2QG, United Kingdom
London
London W12 0HS, United Kingdom
Glasgow
Glasgow G12 0YN, United Kingdom
Sutton
Sutton SM2 5PT, United Kingdom
How to Get in Touch
Bayer Clinical Trials Contact
Sponsor contactCONTACT