Actively Recruiting
A First-in-human Phase 1 Study to Evaluate Safety, Tolerability, and Activity of BAY 3547926 Alone or in Combination in Advanced Hepatocellular Carcinoma
Led by Bayer · Updated on 2026-04-15
148
Participants Needed
13
Research Sites
108 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying a new drug called BAY 3547926 to learn about its safety and effectiveness in people with advanced hepatocellular carcinoma (HCC), a type of liver cancer that has a protein called Glypican 3 (GPC3). This is the first time BAY 3547926 is being tested in humans. The study aims to find the best dose of the drug and understand how it is absorbed and distributed in the body. BAY 3547926 is an antibody linked to a radioactive substance called actinium-225. This radioactive agent is delivered directly to the cancer cells, where it emits radiation that can kill the cancer cells while limiting damage to nearby healthy tissues. The study includes four parts: Part 1 tests different doses alone to find the safest and most effective dose, while Parts 2, 3, and 4 will give this dose either alone or combined with other treatments to more participants. Participants will undergo regular health check-ups, body scans like CT or MRI, blood and urine tests, and answer questions about their health and symptoms. The study will closely monitor side effects, tumor response using RECIST 1.1 criteria, and how long the benefits last. Follow-up will continue for up to 60 months after the first dose to evaluate safety and effectiveness outcomes.
CONDITIONS
Brief 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...
- Adults aged 18 years or older
- Locally advanced, metastatic, or unresectable hepatocellular carcinoma confirmed by biopsy or imaging
- Tumor positive for Glypican 3 (GPC3) by immunohistochemistry
- Disease not suitable for or progressing after surgery or established local treatments
- ECOG Performance Status of 0 or 1
- At least one measurable tumor lesion by CT or MRI within 28 days before treatment
- Adequate bone marrow and organ function
You will not qualify if you...
- Fibrolamellar, sarcomatoid, or mixed hepatocellular/cholangiocarcinoma subtypes
- History or evidence of brain metastases unless meeting specific criteria
- History of encephalopathy grade 2 or higher within the past 12 months
- Clinically significant ascites
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 60 months after first administration
Participants receive the study drug BAY 3547926, an antibody conjugate labeled with actinium-225, alone or in combination, to evaluate safety, tolerability, and activity.
Multiple visits for drug administration and assessments throughout treatment
Duration - Up to 60 months after first administration
Participants are monitored for safety, tolerability, and anti-tumor activity after treatment ends.
Visits scheduled according to protocol for long-term safety and activity monitoring
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
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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