NCT06764316 · Bayer
A First-in-human Study to Learn About the Safety of BAY 3547926 and How Well it Works in Participants With Advanced Liver Cancer
(BANTAM-01)
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
BAY 3547926
antibody conjugate with actinium-225 label
DRUG
BAY 3547922
antibody conjugate without actinium-225 label as preinjection
DRUG
BAY 3713391
Radioactive imaging agent - optional preinjection
DRUG
BAY 3713389
optional preinjection
Primary outcome measures
Part 1 (dose escalation): Occurrence and severity of TEAEs
Time frame: up to 60 months after first administration
TEAE=Treatment emergent adverse event
Part 1 (dose escalation): Recommended safe and active dose (RSAD)
Time frame: 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 TEAEs
Time frame: up to 60 months after first administration
TEAE=Treatment emergent adverse event
Part 2 (dose expansion): ORR using RECIST 1.1 by investigator assessment
Time frame: up 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 assessment
Time frame: up 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 assessment
Time frame: up 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 assessment
Time frame: up 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 TEAEs
Time frame: up 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 assessment
Time frame: up 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 assessment
Time frame: up 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 assessment
Time frame: up 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 assessment
Time frame: up to 60 months after first administration
PFS=Progression free survivial
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Dothan, Alabama
- Duarte, California
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 10, 2026 · Source of record for eligibility and locations