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.
Age range
18 Years
Sex
ALL
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The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Part 1 (dose escalation): Occurrence and severity of TEAEs
Timeframe: up to 60 months after first administration
Part 1 (dose escalation): Recommended safe and active dose (RSAD)
Timeframe: up to 60 months after first administration
Part 2 (dose expansion): Occurrence and severity of TEAEs
Timeframe: up to 60 months after first administration
Part 2 (dose expansion): ORR using RECIST 1.1 by investigator assessment
Timeframe: up to 60 months after first administration
Part 2 (dose expansion): DCR using RECIST 1.1 by investigator assessment
Timeframe: up to 60 months after first administration
Part 2 (dose expansion): DoR using RECIST 1.1 by investigator assessment
Timeframe: up to 60 months after first administration
Part 2 (dose expansion): PFS using RECIST 1.1 by investigator assessment
Bayer Clinical Trials Contact
Timeframe: up to 60 months after first administration
Parts 3 and 4 (dose expansion in combination): Occurrence and severity of TEAEs
Timeframe: up to 60 months after first administration
Parts 3 and 4 (dose expansion in combination): ORR using RECIST 1.1 by investigator assessment
Timeframe: up to 60 months after first administration
Parts 3 and 4 (dose expansion in combination): DCR using RECIST 1.1 by investigator assessment
Timeframe: up to 60 months after first administration
Parts 3 and 4 (dose expansion in combination): DoR using RECIST 1.1 by investigator assessment
Timeframe: up to 60 months after first administration
Parts 3 and 4 (dose expansion in combination): PFS using RECIST 1.1 by investigator assessment
Timeframe: up to 60 months after first administration