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NCT06764316PHASE1Recruiting

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

Bayer

Start Date

2/28/2025

Completion Date

8/31/2031

Summary

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

BAY 3547926

DRUG

BAY 3547922

DRUG

BAY 3713391

DRUG

BAY 3713389

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Conditions

Hepatocellular Carcinoma

Locations

Dothan

Dothan, Alabama 36303

United States

Duarte

Duarte, California 91010

United States

Edegem

Edegem, Antwerp 2650

Belgium

Leuven

Leuven, Flemish Brabant 3000

Belgium

Kortrijk

Kortrijk, West Flanders 8500

Belgium

Toronto

Toronto, Ontario M5G 2C4

Canada

Montreal

Montreal, Quebec H2X 0C1

Canada

Montreal

Montreal, Quebec H4A 3J1

Canada

Sherbrooke

Sherbrooke, Quebec J1H 5N4

Canada

Xuhui District

Xuhui, Shanghai Municipality 200032

China

Tampere

Tampere, Pirkanmaa 33520

Finland

Turku

Turku, Southwest Finland 20540

Finland

Montpellier

Montpellier, Occitanie 34298

France

L'Hospitalet de Llobregat

L'Hospitalet de Llobregat, Barcelona 08908

Spain

Madrid

Madrid, Madrid 28050

Spain

Pamplona

Pamplona,

Spain

London

London, Greater London NW3 2QG

United Kingdom

London

London, Greater London W12 0HS

United Kingdom

Glasgow

Glasgow, Scotland G12 0YN

United Kingdom

Sutton

Sutton, Surrey SM2 5PT

United Kingdom