Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT06764316

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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A First-in-human Study to Learn About the Safety of BAY 3547926 and How Well it Works in Participants With Advanced Liver Cancer | DecenTrialz