Recently added Catalysts

BAY 3547926

Phase 1

Hepatocellular Carcinoma | Small molecule | Oncology |Bayer AG|Last Updated: Aug 18, 2026

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED

Total Trials1

Total Enrollment148

FDA Designations

No designations recorded

Clinical trial landscape

BAY 3547926 · 1 trial · 1 indication

Phase 1 1

NCT06764316A First-in-human Study to Learn About the Safety of BAY 3547926 and How Well it Works in Participants With Advanced Liver CancerHepatocellular Carcinoma

RECRUITING148 Analytics

PHASE1RECRUITING

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

Hepatocellular Carcinoma

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Study Endpoints

Primary Endpoints

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

up to 60 months after first administration

TEAE=Treatment emergent adverse event

Part 1 (dose escalation): Recommended safe and active dose (RSAD)

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

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

up to 60 months after first administration

TEAE=Treatment emergent adverse event

Part 2 (dose expansion): ORR using RECIST 1.1 by investigator assessment

up to 60 months after first administration

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

Part 2 (dose expansion): DCR using RECIST 1.1 by investigator assessment

up to 60 months after first administration

DCR=Disease control rate RECIST=Response Evaluation Criteria in Solid Tumors

Part 2 (dose expansion): DoR using RECIST 1.1 by investigator assessment

up to 60 months after first administration

DoR=Duration of response RECIST=Response Evaluation Criteria in Solid Tumors

Part 2 (dose expansion): PFS using RECIST 1.1 by investigator assessment

up to 60 months after first administration

PFS=Progression free survival RECIST=Response Evaluation Criteria in Solid Tumors

Parts 3 and 4 (dose expansion in combination): Occurrence and severity of TEAEs

up to 60 months after first administration

TEAE=Treatment emergent adverse event

Parts 3 and 4 (dose expansion in combination): ORR using RECIST 1.1 by investigator assessment

up to 60 months after first administration

ORR= Objective response rate

Parts 3 and 4 (dose expansion in combination): DCR using RECIST 1.1 by investigator assessment

up to 60 months after first administration

DCR=Disease control rate

Parts 3 and 4 (dose expansion in combination): DoR using RECIST 1.1 by investigator assessment

up to 60 months after first administration

DoR=Duration of response

Parts 3 and 4 (dose expansion in combination): PFS using RECIST 1.1 by investigator assessment

up to 60 months after first administration

PFS=Progression free survivial

Secondary Endpoints

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

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Study Design & Arms

AllocationNA

MaskingNONE

ModelSINGLE_GROUP

PurposeOTHER

Treatment Arms

Arm	Type	Description
BAY 3547926	EXPERIMENTAL	actinium-225 labeled antibody conjugate

Interventions

Name	Type	Description
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

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Eligibility Criteria

Age Range18 Years to N/A

SexALL

Healthy VolunteersNo

Study Sites24

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...

Countries:United StatesBelgiumCanadaChinaFinlandFranceJapanSpainUnited Kingdom

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Recent Changes (Last 90 Days)

LOWAug 18, 2026NCT06764316lastUpdatePostDate: changed

LOWAug 18, 2026NCT06764316lastUpdatePostDate: changed

MEDIUMJul 15, 2026NCT06764316lastUpdatePostDate: changed

MEDIUMJul 15, 2026NCT06764316lastUpdatePostDate: changed

MEDIUMJul 10, 2026NCT06764316lastUpdatePostDate: changed

MEDIUMJul 10, 2026NCT06764316lastUpdatePostDate: changed

MEDIUMJul 9, 2026NCT06764316lastUpdatePostDate: changed

MEDIUMJul 9, 2026NCT06764316lastUpdatePostDate: changed

Frequently asked questions about BAY 3547926

What is BAY 3547926 used for?

BAY 3547926 is an investigational small molecule being studied for the treatment of hepatocellular carcinoma, a type of advanced liver cancer. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who is developing BAY 3547926?

BAY 3547926 is being developed by Bayer AG, a multinational pharmaceutical company. The company is conducting a first-in-human study to evaluate the safety and efficacy of the drug in participants with advanced liver cancer.

What phase is BAY 3547926 in?

BAY 3547926 is in Phase 1 clinical development. The drug is currently being evaluated in an early-stage trial to assess its safety, tolerability, and preliminary effectiveness in patients with hepatocellular carcinoma. It remains investigational and is not yet approved.

What clinical trials is BAY 3547926 in?

BAY 3547926 is being studied in a Phase 1 clinical trial with the identifier NCT06764316. This first-in-human study is recruiting participants with advanced liver cancer and aims to evaluate the safety and efficacy of the drug. The trial is enrolling approximately 148 participants.

Is BAY 3547926 FDA approved?

BAY 3547926 is not FDA approved. The drug is currently in Phase 1 clinical development, meaning it is still being tested in early-stage trials to determine its safety and effectiveness. It has not yet received regulatory approval for any use.