Hepatocellular CarcinomaPhase 1BANTAM-01NCT06764316
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 Phase 1 study testing BAY 3547926, BAY 3547922 and BAY 3713391 in people with Hepatocellular Carcinoma, run by Bayer at 36 sites in 9 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- BAY 3547926, BAY 3547922 and BAY 3713391
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 36 sitesin 9 countries
- Study dates
- 28 Feb 2025to 31 Aug 2031
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
36 sites in 9 countries. Contact the study team or a site near you to ask about taking part.
36 sites in 9 countries
Canada5 sites, 5 recruiting
- Not yet recruiting
Edmonton
Edmonton, T6G 1Z2
- Recruiting
Montreal
Montreal, Quebec, H2X 0C1
- Recruiting
Montreal
Montreal, Quebec, H4A 3J1
- Recruiting
Sherbrooke
Sherbrooke, Quebec, J1H 5N4
- Recruiting
Toronto
Toronto, Ontario, M5G 2C4
Spain5 sites, 5 recruiting
- Recruiting
Barcelona
Barcelona, Barcelona, 08908
- Not yet recruiting
Barcelona
Barcelona, 08035
- Recruiting
Madrid
Madrid, Madrid, 28050
- Recruiting
Madrid
Madrid, 28027
- Recruiting
Pamplona
Pamplona, 31008
United Kingdom5 sites, 5 recruiting
- Recruiting
Glasgow
Glasgow, Scotland, G12 0YN
- Recruiting
London
London, Greater London, NW3 2QG
- Recruiting
London
London, Greater London, W12 0HS
- Not yet recruiting
London
London, SE59RS
- Recruiting
Sutton
Sutton, Surrey, SM2 5PT
United States4 sites, 4 recruiting
- Recruiting
Dothan
Dothan, Alabama, 36303
jlove@alocentclinical.com
- Recruiting
Duarte
Duarte, California, 91010
- Not yet recruiting
Nashville
Nashville, Tennessee, 37232
- Not yet recruiting
Orlando
Orlando, Florida, 32804
Belgium4 sites, 4 recruiting
- Recruiting
Brussel
Brussels, 1200
- Recruiting
Edegem
Edegem, Antwerp, 2650
- Recruiting
Kortrijk
Kortrijk, West Flanders, 8500
- Recruiting
Leuven
Leuven, Flemish Brabant, 3000
France4 sites, 4 recruiting
- Recruiting
Bron
Bron, 69500
- Recruiting
Montpellier
Montpellier, Occitanie, 34298
- Recruiting
Nantes
Nantes, 44093
- Recruiting
Villejuif
Villejuif, 94805
China3 sites, 3 recruiting
- Not yet recruiting
Fujian
Fujian, 350005
- Not yet recruiting
Wuhan
Wuhan, 430023
- Recruiting
Xuhui District
Xuhui, Shanghai Municipality, 200032
Finland3 sites, 3 recruiting
- Not yet recruiting
Helsinki
Helsinki, 00029
- Recruiting
Tampere
Tampere, Pirkanmaa, 33520
- Recruiting
Turku
Turku, Southwest Finland, 20540
Japan3 sites, 3 recruiting
- Recruiting
Kashiwa
Kashiwa, 277-8577
- Recruiting
Tokyo
Tokyo, 104-0045
- Recruiting
Tokyo
Tokyo, 135-8550
About this study
Official title: 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)
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.
Read more
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.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- BAY 3547926, BAY 3547922, BAY 3713391, BAY 3713389
- Keywords
- Hepatocellular carcinoma (HCC), Locally advanced HCC, Metastatic HCC, Unresectable HCC
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAY 3547926Drug
antibody conjugate with actinium-225 label
BAY 3547922Drug
antibody conjugate without actinium-225 label as preinjection
BAY 3713391Drug
Radioactive imaging agent - optional preinjection
BAY 3713389Drug
optional preinjection
| Study group | Role | What they receive |
|---|---|---|
| BAY 3547926 | Experimental | actinium-225 labeled antibody conjugate Receives: Drug: BAY 3547926; Drug: BAY 3547922; Drug: BAY 3713391; Drug: BAY 3713389 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1 (dose escalation): Occurrence and severity of TEAEs
TEAE=Treatment emergent adverse event
Measured: up to 60 months after first administration
Part 1 (dose escalation): Recommended safe and active dose (RSAD)
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
Measured: up to 60 months after first administration
Part 2 (dose expansion): Occurrence and severity of TEAEs
TEAE=Treatment emergent adverse event
Measured: up to 60 months after first administration
Part 2 (dose expansion): ORR using RECIST 1.1 by investigator assessment
ORR=Objective reponse rate RECIST=Response Evaluation Criteria in Solid Tumors
Measured: up to 60 months after first administration
Part 2 (dose expansion): DCR using RECIST 1.1 by investigator assessment
DCR=Disease control rate RECIST=Response Evaluation Criteria in Solid Tumors
Measured: up to 60 months after first administration
Part 2 (dose expansion): DoR using RECIST 1.1 by investigator assessment
DoR=Duration of response RECIST=Response Evaluation Criteria in Solid Tumors
Measured: up to 60 months after first administration
Part 2 (dose expansion): PFS using RECIST 1.1 by investigator assessment
PFS=Progression free survival RECIST=Response Evaluation Criteria in Solid Tumors
Measured: up to 60 months after first administration
Parts 3 and 4 (dose expansion in combination): Occurrence and severity of TEAEs
TEAE=Treatment emergent adverse event
Measured: up to 60 months after first administration
Parts 3 and 4 (dose expansion in combination): ORR using RECIST 1.1 by investigator assessment
ORR= Objective response rate
Measured: up to 60 months after first administration
Parts 3 and 4 (dose expansion in combination): DCR using RECIST 1.1 by investigator assessment
DCR=Disease control rate
Measured: up to 60 months after first administration
Parts 3 and 4 (dose expansion in combination): DoR using RECIST 1.1 by investigator assessment
DoR=Duration of response
Measured: up to 60 months after first administration
Parts 3 and 4 (dose expansion in combination): PFS using RECIST 1.1 by investigator assessment
PFS=Progression free survivial
Measured: up to 60 months after first administration
Secondary outcomes (20)
Part 1 (dose escalation): Recommended dose level(s) based on occurrence and severity of TEAEs and DLTs, PK, immunogenicity, and preliminary anit-tumor activity (ORR using RECIST 1.1 by Investigator assessment)
TEAE=Treatment emergent adverse event DLT=Dose limiting toxicity PK=Pharmacokinetic ORR=Objective response rate RECIST=Response Evaluation Criteria in Solid Tumors
Measured: up to 60 months after first administration
Part 1 (dose escalation): Recommended dosing regimen based on occurrence and severity of TEAEs and DLTs, PK, immunogenicity, and preliminary anti-tumor activity (ORR using RECIST 1.1 by Investigator assessment)
TEAE=Treatment emergent adverse event DLT=Dose limiting toxicity PK=Pharmacokinetic ORR=Objective response rate RECIST=Response Evaluation Criteria in Solid Tumors
Measured: up to 60 months after first administration
Part 1 (dose escalation): ORR using RECIST 1.1 by investigator assessment
ORR=Objective response rate RECIST=Response Evaluation Criteria in Solid Tumors
Measured: up to 60 months after first administration
Part 1 (dose escalation): DCR using RECIST 1.1 by investigator assessment
DCR=Disease control rate RECIST=Response Evaluation Criteria in Solid Tumors
Measured: up to 60 months after first administration
Part 1 (dose escalation): DoR using RECIST 1.1 by investigator assessment
DoR=Duration of response RECIST=Response Evaluation Criteria in Solid Tumors
Measured: Up to 60 months after first administration
Part 1 (dose escalation): PFS using RECIST 1.1 by investigator assessment
PFS=Progression free survival RECIST=Response Evaluation Criteria in Solid Tumors
Measured: up to 60 months after first administration
Part 1 (dose escalation): Cmax of BAY 3547926 after a single dose and after multiple doses
Cmax=Maximal blood concentration
Measured: up to 36 weeks after first administration
Part 1 (dose escalation): AUC of BAY 3547926 after a single dose and after multiple doses
AUC=Area under the blood concentration versus time curve
Measured: up to 36 weeks after first administration
Part 1 (dose escalation): Clearance of BAY 3547926 after a single dose and after multiple doses if data allow
PK=Pharmacokinetic
Measured: up to 36 weeks after first administration
Part 2 (dose expansion): Recommended dose based on safety, PK, IG and markers of pharmacodynamic activity and efficacy assessments
PK=Pharmacokinetic IG=Immunogenicity
Measured: up to 36 months after first administration
Part 2 (dose expansion): Recommended schedule based on safety, PK, IG and markers of pharmacodynamic activity and efficacy assessments
PK=Pharmacokinetic IG=Immunogenicity
Measured: up to 36 months after first administration
Part 2 (dose expansion): Cmax of BAY 3547926 after a single dose and after multiple doses
Cmax=maximal blood concentration
Measured: up to 36 weeks after first administration
Part 2 (dose expansion): AUC of BAY 3547926 after a single dose and after multiple doses
AUC=Area under curve of blood concentration versus time curve
Measured: up to 36 weeks after first administration
Part 2 (dose expansion): Clearance of BAY 3547926 after single dose and after multiple doses, where applicable and if data allow
PK=Pharmacokinetic
Measured: up to 36 weeks after first administration
Parts 3 and 4 (dose expansion in combination): Recommended dose level(s) of BAY 3547926 based on clinical data including, but not limited to, occurrence and severity of TEAEs and DLTs, PK and IG
TEAE=Treatment emergent adverse event DLT=Dose limiting toxicity PK=Pharmacokinetic IG=Immunogenicity
Measured: up to 60 months after first administration
Parts 3 and 4 (dose expansion in combination): Recommended dosing regimen of BAY 3547926 based on clinical data including, but not limited to, occurrence and severity of TEAEs and DLTs, PK and IG
TEAE=Treatment emergent adverse event DLT=Dose limiting toxicity PK=Pharmacokinetic IG=Immunogenicity
Measured: up to 60 months after first administration
Parts 3 and 4 (dose expansion in combination): Recommended schedule of BAY 3547926 based on severity of TEAEs, PK, IG
TEAE=Treatment emergent adverse event DLT=Dose limiting toxicity PK=Pharmacokinetic IG=Immunogenicity
Measured: up to 60 months after first administration
Parts 3 and 4 (dose expansion in combination): Cmax of BAY 3547926 after a single dose and after multiple doses of BAY 3547926 in combination
Cmax=maximal blood concentration
Measured: up to 60 months after first administration
Parts 3 and 4 (dose expansion in combination): AUC of BAY 3547926 after single dose and after multiple doses of BAY 3547926 in combination
AUC=Area under curve of blood concentration versus time curve
Measured: up to 60 months after first administration
Parts 3 and 4 (dose expansion in combination): Clearance of BAY 3547926 after single dose and after multiple doses of BAY 3547926 in combination, where applicable and if data allow
PK=Pharmacokinetic
Measured: up to 60 months after first administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2025
- Study start28 Feb 2025
- Primary completion31 Jul 2029 (estimated)
- Study completion31 Aug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06764316
- Sponsor's protocol ID
- 22262
- Other IDs
- 2024-516615-25-00
- Acronym
- BANTAM-01
- Status last verified
- Jul 2026
- First submitted
- 18 Dec 2024
- Last updated
- 21 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.