A First-in-human Study to Learn About the Safety of BAY 3547926 and How Well it Works in Participants With Advanced Liver Cancer (NCT06764316)
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)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Dothan — Dothan, Alabama
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (24 Sites)
- Dothan — Dothan, Alabama
- Duarte — Duarte, California
- Edegem — Edegem, Antwerp
- Leuven — Leuven, Flemish Brabant
- Kortrijk — Kortrijk, West Flanders
- Brussel — Brussels,
- Toronto — Toronto, Ontario
- Montreal — Montreal, Quebec
- Montreal — Montreal, Quebec
- Sherbrooke — Sherbrooke, Quebec
- Xuhui District — Xuhui, Shanghai Municipality
- Tampere — Tampere, Pirkanmaa
- Turku — Turku, Southwest Finland
- Montpellier — Montpellier, Occitanie
- Villejuif — Villejuif,
- Tokyo — Tokyo,
- Barcelona — Barcelona, Barcelona
- Madrid — Madrid, Madrid
- Madrid — Madrid,
- Pamplona — Pamplona,
- London — London, Greater London
- London — London, Greater London
- Glasgow — Glasgow, Scotland
- Sutton — Sutton, Surrey
📞 Contact the Study Coordinator
Phone: (888) 842-2937
Email: clinical-trials-contact@bayer.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Hepatocellular Carcinoma
- TACE With or Without SBRT as Bridging Therapy for Pre-transplant HCC Patients — Maywood, Illinois
- Cryoablation and Arterial Infusion of SD-101 in Combination With Durvalumab and Tremelimumab — San Diego, California
- Feasibility and Efficacy of Perioperative Nivolumab With or Without Relatlimab for Patients With Potentially Resectable Hepatocellular Carcinoma (HCC) — Baltimore, Maryland
- TheraSphere With Durvalumab and Tremelimumab for HCC — San Diego, California
- Blood Salvage in Orthotopic Liver Transplantation With HCC — Toronto, Ontario
- Study to Evaluate Adverse Events, and Change in Disease Activity, When Intravenously (IV) Infused With Livmoniplimab in Combination With IV Infused Budigalimab in Adult Participants With Hepatocellular Carcinoma (HCC) — Prescott Valley, Arizona
Explore by condition: All Hepatocellular Carcinoma clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.