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BAY3630942

Phase 1

Hepatocellular Carcinoma (HCC) | Small molecule | Oncology |Bayer AG|Last Updated: Apr 13, 2025

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment14

FDA Designations

No designations recorded

Clinical trial landscape

BAY3630942 · 1 trial · 2 indications

Phase 1 1
NCT06345001A 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 CancersHepatocellular Carcinoma (HCC)
COMPLETED14 Analytics
PHASE1COMPLETED
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
Hepatocellular Carcinoma (HCC)
NCT0634500114
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Study Endpoints

Primary Endpoints

Radioactivity concentration (SUVmean, %ID/g) of BAY3630942 in normal organs (including but not limited to kidney, spleen, liver, and bone marrow) as a function of time using 3 post-administration PET/CT scans
Up to 12 days
Zirconium-89 absorbed doses (mGy/MBq) in normal organs
Up to 12 days
Absorbed doses (mGy/MBq) from actinium-225 and daughter radionuclides in critical organs estimated
Up to 12 days

By using the normal organ biodistribution time-course data of BAY3630942 (with assumptions on actinium-225 daughter radionuclides redistribution to critical organs)

Secondary Endpoints

Proportion and severity of adverse events (AEs) after administration of BAY3630942 and BAY3547922
Up to 30 days
Cmax (from zirconium-89 radioactivity concentration (Bq/g and %ID/kg) as a function of time in blood)
Up to 12 days
AUC (from zirconium-89 radioactivity concentration (Bq/g and %ID/kg) as a function of time in blood)
Up to 12 days
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeOTHER

Treatment Arms

ArmTypeDescription
Part 1 - Total mass dose selectionEXPERIMENTALParticipants with HCC or other select solid tumors will receive a single dose of BAY3630942 after intravenous (IV) administration of a specified dose of BAY3547922. Up to 5 total mass dose levels may be tested.
Part 2 - Actinium-225 Dosimetry EstimatesEXPERIMENTALParticipants with HCC or other select solid tumors will receive the total mass dose level selected in Part 1.

Interventions

NameTypeDescription
BAY3630942DRUGIV, Single administration
BAY3547922DRUGIV, Single infusion
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Participant (male or female) must be 18 years of age inclusive, at the time of signing the informed consent. * Histologically confirmed HCC or non-invasive diagnosis of HCC according to American Association for the Study of Liver Diseases (AASLD) criteria * Histologically or c...

Countries:United States
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Frequently asked questions about BAY3630942

What is BAY3630942 used for?

BAY3630942 is an investigational small molecule being studied for the treatment of hepatocellular carcinoma (HCC), a type of liver cancer. It is also being evaluated in other select solid cancers. The drug is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who makes BAY3630942?

BAY3630942 is being developed by Bayer AG, a multinational pharmaceutical company. Bayer is listed on the stock exchange under the ticker symbol BAYRY. The company is conducting clinical trials to evaluate the safety and pharmacokinetics of this investigational drug in patients with liver cancer.

What phase is BAY3630942 in?

BAY3630942 is in Phase 1 clinical development. A first-in-human study has been completed to evaluate how the drug is distributed and processed in the body and to assess its safety in patients with hepatocellular carcinoma or other select solid cancers. The drug remains investigational and is not yet approved.

What clinical trials is BAY3630942 in?

BAY3630942 has one completed clinical trial registered under NCT06345001. This Phase 1 study, titled '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,' enrolled 14 participants in the United States.

How does BAY3630942 work?

BAY3630942 is a small molecule therapeutic agent. Its specific molecular target has not been disclosed in available clinical trial information. The drug is being investigated for its potential to treat hepatocellular carcinoma and other solid tumors, but its mechanism of action is not publicly detailed.