Actively Recruiting
A First-in-human Study to Learn About the Safety of BAY 3547926 and How Well it Works in Participants With Advanced Liver Cancer
Led by Bayer · Updated on 2026-04-15
148
Participants Needed
13
Research Sites
339 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A First-in-human Study to Learn About the Safety of BAY 3547926 and How Well it Works in Participants With Advanced Liver Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have locally advanced, metastatic, or unresectable hepatocellular carcinoma confirmed by biopsy or non-invasive diagnosis with cirrhosis
- Have tumors that test positive for Glypican 3 (GPC3) protein by immunohistochemistry
- Disease not treatable by surgery or local therapies, or disease that progressed after these treatments
- Have an ECOG performance status of 0 or 1
- Have at least one measurable tumor lesion by CT or MRI within 28 days before starting treatment
- Have adequate bone marrow and organ function
You will not qualify if you...
- Have fibrolamellar, sarcomatoid, or mixed hepatocellular/cholangiocarcinoma subtypes
- Have a history or signs of brain metastases unless meeting specific criteria
- Had encephalopathy grade 2 or higher in the past 12 months
- Have clinically significant fluid buildup in the abdomen (ascites)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 13 locations
1
Edegem
Edegem, Belgium, 2650
Actively Recruiting
2
Kortrijk
Kortrijk, Belgium, 8500
Actively Recruiting
3
Leuven
Leuven, Belgium, 3000
Actively Recruiting
4
Toronto
Toronto, Ontario, Canada, M5G 2C4
Actively Recruiting
5
Montréal
Montreal, Quebec, Canada, H2X 0C1
Actively Recruiting
6
Montreal
Montreal, Quebec, Canada, H4A 3J1
Actively Recruiting
7
Sherbrooke
Sherbrooke, Quebec, Canada, J1H 5N4
Actively Recruiting
8
Tampere
Tampere, Pirkanmaa, Finland, 33520
Actively Recruiting
9
Turku
Turku, Southwest Finland, Finland, 20540
Actively Recruiting
10
Madrid
Madrid, Spain, 28050
Actively Recruiting
11
London
London, Greater London, United Kingdom, W12 0HS
Actively Recruiting
12
Glasgow
Glasgow, Scotland, United Kingdom, G12 0YN
Actively Recruiting
13
Sutton
Sutton, Surrey, United Kingdom, SM2 5PT
Actively Recruiting
Research Team
B
Bayer Clinical Trials Contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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