Informations générales (source: ClinicalTrials.gov)
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)
Interventional
Phase 1
Bayer (Voir sur ClinicalTrials)
février 2025
août 2031
21 août 2026
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Antoine HOLLEBECQUE | 07/10/2026 14:40:05 | Contacter | ||
Critères
Tous
- 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