Hepatocellular Carcinoma study: BAY
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
ClinicalTrials.gov ID: NCT06764316
What this study is testing
What is BAY 3547926?
This is an investigational antibody conjugate being studied as a potential treatment for advanced hepatocellular carcinoma. It is designed to deliver a radioactive agent directly to cancer cells to damage them.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to find the safest and most effective dose of BAY 3547926 and to see how the drug behaves in the body. It also looks at how well the drug can kill cancer cells using a small amount of radiation.
- Who it's for
- Adults with advanced hepatocellular carcinoma (a type of liver cancer) that expresses the Glypican 3 protein.
- What's involved
- Participants will receive different doses of the drug in the first part of the study. After the safe dose is found, more people will get the drug alone or with other treatments. Throughout the study, doctors will do health checks, scans, and collect blood and urine samples, and ask about side effects.
- Time commitment
- The study lasts several months, with multiple clinic visits for dosing, monitoring, and testing. The exact number of visits depends on the study part the participant is in.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Locally advanced or metastatic and/or unresectable HCC (hepatocellular carcinoma) with histological or cytological confirmation, or non-invasive...
- 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 how well it works such as...
- 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...
You likely can't join if
- 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
See the full eligibility 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...
- 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 how well it works 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.
- Adequate bone marrow and organ function
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Dothan, Alabama, United States
- Duarte, California, United States
- Edegem, Antwerp, Belgium
- Leuven, Flemish Brabant, Belgium
- Kortrijk, West Flanders, Belgium
- Brussels, Belgium
- Toronto, Ontario, Canada
- Montreal, Quebec, Canada
- Sherbrooke, Quebec, Canada
- Xuhui, Shanghai Municipality, China
- Tampere, Pirkanmaa, Finland
- Turku, Southwest Finland, Finland
- Montpellier, Occitanie, France
- Bron, France
- Nantes, France
- Villejuif, France
- Kashiwa, Japan
- Tokyo, Japan
- Barcelona, Barcelona, Spain
- Madrid, Madrid, Spain
+ 5 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Dothan, Alabama, United States; Duarte, California, United States; Edegem, Antwerp, Belgium; Leuven, Flemish Brabant, Belgium; Kortrijk, West Flanders, Belgium; Brussels, Belgium and 19 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.