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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

148 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-28

Study Completion Date

2033-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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 3 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 Part 3 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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Safety Study of BAY73-4506 in Patients With Hepatocellular Carcinoma

NCT01003015

Carcinoma, Hepatocellular

COMPLETED PHASE2

A First-in-Human Study to Learn About How BAY3630942 is Distributed and Processed Inside the Body When Given After BAY3547922 and How Safe it is in People With Liver Cancer or Other Select Solid Cancers

NCT06345001

Hepatocellular Carcinoma (HCC) Solid Tumors

COMPLETED PHASE1

Assessing BAY86-9766 Plus Sorafenib for the Treatment of Liver Cancer.

NCT01204177

Carcinoma, Hepatocellular

COMPLETED PHASE2

Safety, Tolerability, PK, Anti-Tumor Activity of STP705 in Subjects With Advanced/Metastatic or Surgically Unresectable Solid Tumors Who Are Refractory to Standard Therapy

NCT04676633

Hepatocellular Carcinoma Liver Metastases Cholangiocarcinoma

COMPLETED PHASE1

BMS-247550 in Treating Patients With Liver or Gallbladder Cancer

NCT00023946

Adult Primary Cholangiocellular Carcinoma Adult Primary Hepatocellular Carcinoma Advanced Adult Primary Liver Cancer +11 more

TERMINATED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hepatocellular Carcinoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

BAY 3547926

actinium-225 labeled antibody conjugate

Group Type EXPERIMENTAL

BAY 3547926

Intervention Type DRUG

antibody conjugate with actinium-225 label

BAY 3547922

Intervention Type DRUG

antibody conjugate without actinium-225 label as preinjection

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

BAY 3547926

antibody conjugate with actinium-225 label

Intervention Type DRUG

BAY 3547922

antibody conjugate without actinium-225 label as preinjection

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No