Study of BAY 3547926 for Advanced Liver Cancer
This study is looking at a new drug, BAY 3547926, for people with advanced hepatocellular carcinoma (HCC), a type of liver cancer. Researchers want to understand how safe BAY 3547926 is and how well it works. The drug delivers a radioactive agent that targets and damages cancer cells, aiming to cause little harm to healthy tissues. This is the first time BAY 3547926 is being tested in humans. The study will also help determine the best dose of BAY 3547926 and how your body processes it. You may be eligible if you have advanced HCC that has a special protein called Glypican 3 (GPC3).
- Study design
- This is a first-in-human study with a planned enrollment of 148 participants. It will first find a safe dose (Part 1) and then expand to further test that dose (Part 2).
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for up to 60 months (5 years) after their first administration of the study drug to monitor for side effects.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A First-in-human Study to Learn About the Safety of BAY 3547926 and How Well it Works in Participants With Advanced Liver Cancer
At a glance
Conditions
NCT06764316
Where you'd take part
This study runs at 24 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Dothan
Dothan, Alabamastudy coordinator listed
Recruiting
Barcelona
Barcelona, Barcelona, Spainno site contact published
Recruiting
Brussel
Brussels, Belgiumno site contact published
Recruiting
Duarte
Duarte, Californiano site contact published
Recruiting
Edegem
Edegem, Antwerp, Belgiumno site contact published
Recruiting
Glasgow
Glasgow, Scotland, United Kingdomno site contact published
Recruiting
Kortrijk
Kortrijk, West Flanders, Belgiumno site contact published
Recruiting
Leuven
Leuven, Flemish Brabant, Belgiumno site contact published
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
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Inclusion
Exclusion
What this trial measures
- Part 1 (dose escalation): Occurrence and severity of TEAEsup to 60 months after first administration
TEAE=Treatment emergent adverse event
- Part 1 (dose escalation): Recommended safe and active dose (RSAD)up to 60 months after first administration
The RSAD is based on incidence of DLT and preliminary anti-tumor activity (ORR using RECIST 1.1 by Investigator assessment) informed by TITE-CRM. RSAD=Recommended safe and active dose DLT=Dose limiting toxicity ORR=Objective reponse rate RECIST=Response Evaluation Criteria in Solid Tumors TITE-CRM =Time-to-event continual reassessment method
- Part 2 (dose expansion): Occurrence and severity of TEAEsup to 60 months after first administration
TEAE=Treatment emergent adverse event
- Part 2 (dose expansion): ORR using RECIST 1.1 by investigator assessmentup to 60 months after first administration
ORR=Objective reponse rate RECIST=Response Evaluation Criteria in Solid Tumors
- Part 2 (dose expansion): DCR using RECIST 1.1 by investigator assessmentup to 60 months after first administration
DCR=Disease control rate RECIST=Response Evaluation Criteria in Solid Tumors
- Part 2 (dose expansion): DoR using RECIST 1.1 by investigator assessmentup to 60 months after first administration
DoR=Duration of response RECIST=Response Evaluation Criteria in Solid Tumors
- Part 2 (dose expansion): PFS using RECIST 1.1 by investigator assessmentup to 60 months after first administration
PFS=Progression free survival RECIST=Response Evaluation Criteria in Solid Tumors
- Parts 3 and 4 (dose expansion in combination): Occurrence and severity of TEAEsup to 60 months after first administration
TEAE=Treatment emergent adverse event
- Parts 3 and 4 (dose expansion in combination): ORR using RECIST 1.1 by investigator assessmentup to 60 months after first administration
ORR= Objective response rate
- Parts 3 and 4 (dose expansion in combination): DCR using RECIST 1.1 by investigator assessmentup to 60 months after first administration
DCR=Disease control rate
- Parts 3 and 4 (dose expansion in combination): DoR using RECIST 1.1 by investigator assessmentup to 60 months after first administration
DoR=Duration of response
- Parts 3 and 4 (dose expansion in combination): PFS using RECIST 1.1 by investigator assessmentup to 60 months after first administration
PFS=Progression free survivial