Recruiting
Phase 1

BAY 3547926

Sponsor:

Bayer

Code:

NCT06764316

Conditions

Hepatocellular Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

BAY 3547926

BAY 3547922

BAY 3713391

BAY 3713389

Study Details

Brief 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). 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.

Conditions

Hepatocellular Carcinoma

Study ID

NCT06764316

Start date

Feb 28, 2025

Status verified date

Jul, 2026

Completion date

Aug 31, 2031

Anticipated

Primary completion date

Jul 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

148 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: BAY 3547926

actinium-225 labeled antibody conjugate

Interventions

BAY 3547926

antibody conjugate with actinium-225 label

BAY 3547922

antibody conjugate without actinium-225 label as preinjection

BAY 3713391

Radioactive imaging agent - optional preinjection

BAY 3713389

optional preinjection

Primary outcome measure

  • Part 1 (dose escalation): Occurrence and severity of TEAEs [ Time Frame: up to 60 months after first administration ]
  • Part 1 (dose escalation): Recommended safe and active dose (RSAD) [ Time Frame: up to 60 months after first administration ]
  • Part 2 (dose expansion): Occurrence and severity of TEAEs [ Time Frame: up to 60 months after first administration ]
  • Part 2 (dose expansion): ORR using RECIST 1.1 by investigator assessment [ Time Frame: up to 60 months after first administration ]
  • Part 2 (dose expansion): DCR using RECIST 1.1 by investigator assessment [ Time Frame: up to 60 months after first administration ]
  • Part 2 (dose expansion): DoR using RECIST 1.1 by investigator assessment [ Time Frame: up to 60 months after first administration ]
  • Part 2 (dose expansion): PFS using RECIST 1.1 by investigator assessment [ Time Frame: up to 60 months after first administration ]
  • Parts 3 and 4 (dose expansion in combination): Occurrence and severity of TEAEs [ Time Frame: up to 60 months after first administration ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Bayer Clinical Trials Contact

(+)1-888-84 22937clinical-trials-contact@bayer.com

Locations

Dothan

Recruiting

Dothan, Alabama, United States, 36303

Contacts

jlove@alocentclinical.com

Duarte

Recruiting

Duarte, California, United States, 91010

Toronto

Recruiting

Toronto, Ontario, Canada, M5G 2C4

Montreal

Recruiting

Montreal, Quebec, Canada, H2X 0C1

Montreal

Recruiting

Montreal, Quebec, Canada, H4A 3J1

Sherbrooke

Recruiting

Sherbrooke, Quebec, Canada, J1H 5N4

More Information

Sponsor

Bayer

Last update posted

Aug 18, 2026

Last verified

Jul, 2026

Keywords

  • Hepatocellular carcinoma (HCC)
  • Locally advanced HCC
  • Metastatic HCC
  • Unresectable HCC

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Bayer on 2026-08-18.