RecruitingPhase 1NCT06764316

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

A Multicenter, Open Label, Non-randomized First-in-human Phase 1 Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of BAY 3547926 Alone, and in Combination, in Participants With Advanced Hepatocellular Carcinoma (HCC)


Sponsor

Bayer

Enrollment

148 participants

Start Date

Feb 28, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is a first-in-human study testing the safety of a new drug called BAY 3547926 in people with advanced liver cancer (hepatocellular carcinoma or HCC) that tests positive for a protein called GPC3. It is an early-phase trial primarily testing safety and dosing. **You may be eligible if...** - You have locally advanced, metastatic, or surgically unresectable hepatocellular carcinoma (HCC) - Your tumor has confirmed GPC3 protein expression on testing - Standard treatments like surgery, ablation, or embolization have not worked or are no longer an option - You are in good general health (ECOG performance status 0–1) - You have at least one measurable tumor on CT or MRI **You may NOT be eligible if...** - Your tumor does not express GPC3 - You have other conditions that make experimental treatment too risky - Your cancer can still be treated with established curative therapies Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBAY 3547926

antibody conjugate with actinium-225 label

DRUGBAY 3547922

antibody conjugate without actinium-225 label as preinjection


Locations(13)

Edegem

Edegem, Belgium

Kortrijk

Kortrijk, Belgium

Leuven

Leuven, Belgium

Toronto

Toronto, Ontario, Canada

Montréal

Montreal, Quebec, Canada

Montreal

Montreal, Quebec, Canada

Sherbrooke

Sherbrooke, Quebec, Canada

Tampere

Tampere, Pirkanmaa, Finland

Turku

Turku, Southwest Finland, Finland

Madrid

Madrid, Spain

London

London, Greater London, United Kingdom

Glasgow

Glasgow, Scotland, United Kingdom

Sutton

Sutton, Surrey, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT06764316


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