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NCT Number: NCT06764316

A First-in-human Study to Learn About the Safety of BAY 3547926 and How Well it Works in Participants With Advanced Liver Cancer

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.

Recruiting

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Edegem, Antwerp, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BAY 3547926

Drug

antibody conjugate with actinium-225 label

BAY 3547922

Drug

antibody conjugate without actinium-225 label as preinjection

BAY 3713391

Drug

Radioactive imaging agent - optional preinjection

BAY 3713389

Drug

optional preinjection

Primary outcomes

  1. Part 1 (dose escalation): Occurrence and severity of TEAEs

    Time frame: up to 60 months after first administration

    TEAE=Treatment emergent adverse event

  2. 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

  3. Part 2 (dose expansion): Occurrence and severity of TEAEs

    Time frame: up to 60 months after first administration

    TEAE=Treatment emergent adverse event

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

Secondary outcomes

  1. 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)

    Time frame: up to 60 months after first administration

    TEAE=Treatment emergent adverse event DLT=Dose limiting toxicity PK=Pharmacokinetic ORR=Objective response rate RECIST=Response Evaluation Criteria in Solid Tumors

  2. 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)

    Time frame: up to 60 months after first administration

    TEAE=Treatment emergent adverse event DLT=Dose limiting toxicity PK=Pharmacokinetic ORR=Objective response rate RECIST=Response Evaluation Criteria in Solid Tumors

  3. Part 1 (dose escalation): ORR using RECIST 1.1 by investigator assessment

    Time frame: up to 60 months after first administration

    ORR=Objective response rate RECIST=Response Evaluation Criteria in Solid Tumors

  4. Part 1 (dose escalation): 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

  5. Part 1 (dose escalation): 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

  6. Part 1 (dose escalation): 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

  7. Part 1 (dose escalation): Cmax of BAY 3547926 after a single dose and after multiple doses

    Time frame: up to 36 weeks after first administration

    Cmax=Maximal blood concentration

  8. Part 1 (dose escalation): AUC of BAY 3547926 after a single dose and after multiple doses

    Time frame: up to 36 weeks after first administration

    AUC=Area under the blood concentration versus time curve

  9. Part 1 (dose escalation): Clearance of BAY 3547926 after a single dose and after multiple doses if data allow

    Time frame: up to 36 weeks after first administration

    PK=Pharmacokinetic

  10. Part 2 (dose expansion): Recommended dose based on safety, PK, IG and markers of pharmacodynamic activity and efficacy assessments

    Time frame: up to 36 months after first administration

    PK=Pharmacokinetic IG=Immunogenicity

  11. Part 2 (dose expansion): Recommended schedule based on safety, PK, IG and markers of pharmacodynamic activity and efficacy assessments

    Time frame: up to 36 months after first administration

    PK=Pharmacokinetic IG=Immunogenicity

  12. Part 2 (dose expansion): Cmax of BAY 3547926 after a single dose and after multiple doses

    Time frame: up to 36 weeks after first administration

    Cmax=maximal blood concentration

  13. Part 2 (dose expansion): AUC of BAY 3547926 after a single dose and after multiple doses

    Time frame: up to 36 weeks after first administration

    AUC=Area under curve of blood concentration versus time curve

  14. Part 2 (dose expansion): Clearance of BAY 3547926 after single dose and after multiple doses, where applicable and if data allow

    Time frame: up to 36 weeks after first administration

    PK=Pharmacokinetic

  15. 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

    Time frame: up to 60 months after first administration

    TEAE=Treatment emergent adverse event DLT=Dose limiting toxicity PK=Pharmacokinetic IG=Immunogenicity

  16. 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

    Time frame: up to 60 months after first administration

    TEAE=Treatment emergent adverse event DLT=Dose limiting toxicity PK=Pharmacokinetic IG=Immunogenicity

  17. Parts 3 and 4 (dose expansion in combination): Recommended schedule of BAY 3547926 based on severity of TEAEs, PK, IG

    Time frame: up to 60 months after first administration

    TEAE=Treatment emergent adverse event DLT=Dose limiting toxicity PK=Pharmacokinetic IG=Immunogenicity

  18. 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

    Time frame: up to 60 months after first administration

    Cmax=maximal blood concentration

  19. Parts 3 and 4 (dose expansion in combination): AUC of BAY 3547926 after single dose and after multiple doses of BAY 3547926 in combination

    Time frame: up to 60 months after first administration

    AUC=Area under curve of blood concentration versus time curve

  20. 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

    Time frame: up to 60 months after first administration

    PK=Pharmacokinetic

Study contacts

Contact information is provided by the study sponsor or research team.

Bayer Clinical Trials Contact

CONTACT

[email protected]

(+)1-888-84 22937

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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)

Acronym: BANTAM-01

Important dates

Study start
2025
Primary completion
2029
Study completion
2031
First posted
Jan 8, 2025
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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