Testing a new drug for advanced liver cancer
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)
This study is testing a new drug for advanced liver cancer to see if it can safely target cancer cells while sparing healthy tissue.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 148 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Bayer Industry-sponsored |
| Locations | 13 sites (Edegem and 12 other locations) |
| Trial ID | NCT06764316 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the safety and effectiveness of a new drug called BAY 3547926 in patients with advanced hepatocellular carcinoma (HCC) that expresses a specific protein known as Glypican 3 (GPC3). Participants will receive varying doses of the drug to determine the optimal dose that is both safe and effective. The drug works by delivering a radioactive agent directly to cancer cells, which is designed to minimize damage to surrounding healthy tissues. This is the first time BAY 3547926 is being tested in humans, making it a crucial step in understanding its potential benefits for treating advanced liver cancer.
Who should consider this trial
Good fit: Ideal candidates include individuals with locally advanced or metastatic unresectable hepatocellular carcinoma who have confirmed GPC3 expression.
Not a fit: Patients with liver cancer that is amenable to curative surgery or those with poor organ function may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced liver cancer that is difficult to treat.
How similar studies have performed: While this approach is novel in humans, similar studies targeting GPC3 in liver cancer have shown promise in preclinical models.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Edegem and 12 other locations
- Edegem — Edegem, Belgium (Recruiting)
- Kortrijk — Kortrijk, Belgium (Recruiting)
- Leuven — Leuven, Belgium (Recruiting)
- Toronto — Toronto, Ontario, Canada (Recruiting)
- Montréal — Montreal, Quebec, Canada (Recruiting)
- Montreal — Montreal, Quebec, Canada (Recruiting)
- Sherbrooke — Sherbrooke, Quebec, Canada (Recruiting)
- Tampere — Tampere, Pirkanmaa, Finland (Recruiting)
- Turku — Turku, Southwest Finland, Finland (Recruiting)
- Madrid — Madrid, Spain (Recruiting)
- London — London, Greater London, United Kingdom (Recruiting)
- Glasgow — Glasgow, Scotland, United Kingdom (Recruiting)
- Sutton — Sutton, Surrey, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Bayer Clinical Trials Contact
- Email: clinical-trials-contact@bayer.com
- Phone: (+)1-888-84 22937
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.