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BANTAM-01
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 study identifier
Secondary identifiers
REGISTRY · CTIS (EU)
interventional
148
9 countries
36
Study Start
February 28, 2025
Actual (reported)Primary Completion
July 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
August 31, 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 31, 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 18, 2024
Actual (reported)January 8, 2025
Actual (reported)February 28, 2025
Actual (reported)July 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
August 31, 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Part 1 (dose escalation): Occurrence and severity of TEAEs
TEAE=Treatment emergent adverse event
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
up to 60 months after first administration
Part 2 (dose expansion): Occurrence and severity of TEAEs
TEAE=Treatment emergent adverse event
up to 60 months after first administration
Part 2 (dose expansion): ORR using RECIST 1.1 by investigator assessment
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)
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)
up to 60 months after first administration
Part 1 (dose escalation): ORR using RECIST 1.1 by investigator assessment
up to 60 months after first administration
Part 1 (dose escalation): DCR using RECIST 1.1 by investigator assessment
up to 60 months after first administration
Part 1 (dose escalation): DoR using RECIST 1.1 by investigator assessment
Up to 60 months after first administration
actinium-225 labeled antibody conjugate
antibody conjugate with actinium-225 label
antibody conjugate without actinium-225 label as preinjection
Dothan
Dothan, Alabama, 36303, United States
Duarte
Duarte, California, 91010, United States
Orlando
Orlando, Florida, 32804, United States
First Submitted
December 18, 2024
First Posted
January 8, 2025
Study Start
February 28, 2025
Actual (reported)Primary Completion
July 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
ORR=Objective reponse rate RECIST=Response Evaluation Criteria in Solid Tumors
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
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
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
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
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
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
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
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
up to 60 months after first administration
Radioactive imaging agent - optional preinjection
optional preinjection
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Nashville
Nashville, Tennessee, 37232, United States
Edegem
Edegem, Antwerp, 2650, Belgium
Leuven
Leuven, Flemish Brabant, 3000, Belgium
Kortrijk
Kortrijk, West Flanders, 8500, Belgium
Brussel
Brussels, 1200, Belgium
Toronto
Toronto, Ontario, M5G 2C4, Canada
Montreal
Montreal, Quebec, H2X 0C1, Canada
Montreal
Montreal, Quebec, H4A 3J1, Canada
Sherbrooke
Sherbrooke, Quebec, J1H 5N4, Canada
Edmonton
Edmonton, T6G 1Z2, Canada
Xuhui District
Xuhui, Shanghai Municipality, 200032, China
Fujian
Fujian, 350005, China
Wuhan
Wuhan, 430023, China
Tampere
Tampere, Pirkanmaa, 33520, Finland
Turku
Turku, Southwest Finland, 20540, Finland
Helsinki
Helsinki, 00029, Finland
Montpellier
Montpellier, Occitanie, 34298, France
Bron
Bron, 69500, France
Nantes
Nantes, 44093, France
Villejuif
Villejuif, 94805, France
Kashiwa
Kashiwa, 277-8577, Japan
Tokyo
Tokyo, 104-0045, Japan
Tokyo
Tokyo, 135-8550, Japan
Barcelona
Barcelona, Barcelona, 08908, Spain
Madrid
Madrid, Madrid, 28050, Spain
Barcelona
Barcelona, 08035, Spain
Madrid
Madrid, 28027, Spain
Pamplona
Pamplona, 31008, Spain
London
London, Greater London, NW3 2QG, United Kingdom
London
London, Greater London, W12 0HS, United Kingdom
Glasgow
Glasgow, Scotland, G12 0YN, United Kingdom
Sutton
Sutton, Surrey, SM2 5PT, United Kingdom
London
London, SE59RS, United Kingdom
Study Completion
August 31, 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 21, 2026
Record last verified: 2026-07
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.
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