臨床研究等提出・公開システム

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)

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

Myoishi Masafumi

Bayer Yakuhin, Ltd.

2-4-9 Umeda, Kita-ku, Osaka, Osaka

byl_ct_contact@bayer.com

Dedicated contact

Bayer Yakuhin, Ltd.

2-4-9 Umeda, Kita-ku, Osaka, Osaka

+81-6-6133-6363

byl_ct_contact@bayer.com

Recruiting

June. 11, 2026

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

- 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

- 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

Both

Hepatocellular Carcinoma

Drug: BAY 3547926
antibody conjugate with actinium-225 label
Drug: BAY 3547922
antibody conjugate without actinium-225 label as preinjection

- Part 1 (dose escalation): Occurrence and severity of TEAEs TEAE=Treatment emergent adverse event
- Part 1 (dose escalation): Recommended safe and active dose (RSAD)
- Part 2 (dose expansion): Occurrence and severity of TEAEs
- Part 2 (dose expansion): ORR using RECIST 1.1 by investigator assessment
- Part 2 (dose expansion): DCR using RECIST 1.1 by investigator assessment
- Part 2 (dose expansion): DoR using RECIST 1.1 by investigator assessment
- Part 2 (dose expansion): PFS using RECIST 1.1 by investigator assessment
- Parts 3 and 4 (dose expansion in combination): Occurrence and severity of TEAEs
- Parts 3 and 4 (dose expansion in combination): ORR using RECIST 1.1 by investigator assessment
- Parts 3 and 4 (dose expansion in combination): DCR using RECIST 1.1 by investigator assessment
- Parts 3 and 4 (dose expansion in combination): DoR using RECIST 1.1 by investigator assessment
- Parts 3 and 4 (dose expansion in combination): PFS using RECIST 1.1 by investigator assessment

+81-3-3520-0111

Mar. 10, 2026

No

Belgium/Canada/Finland/Spain/United Kingdom