Clinical Trials | Phase 1/1b single arm, open-label trial of theranostic pair RYZ811 (diagnostic) and RYZ801 (therapeutic) to identify and treat subjects with GPC3+ unresectable hepatocellular carcinoma (HCC)

The University of Virginia Comprehensive Cancer Center seeks adults ages 18 and over with GPC3+ unresectable hepatocellular carcinoma (HCC). The purpose of this study is to learn about the safety and effectiveness of a pair of new radioactive study drugs called RYZ811 (an imaging agent) and RYZ801 (a therapeutic agent). RYZ811 and RYZ801 target a protein (made from the genetic instructions of the cancer cell) expressed on the surface of HCC tumor cells called glypican-3 (GPC3). • RYZ811 is a radioactive imaging agent and is given prior to an imaging test called positron emission tomography (PET) to identify HCC tumors in your body that express GPC3. RYZ811 is an imaging agent only and is not intended to treat your disease. • RYZ801 is a therapeutic agent that delivers targeted radiation to HCC tumors that express GPC3, potentially leading to tumor death. RYZ811 and RYZ801 are considered investigational and are not yet approved by any regulatory agencies such as the U. S. Food and Drug Administration (FDA) for use in patients outside of this research study. The study involves receiving the investigational drugs, as well as coming in for study visits, which include exams, laboratory tests, imaging scans, procedures such as having your blood drawn, and talking to the study doctor. This study comprises an Imaging Stage with RYZ811 and a Study Treatment Stage with RYZ801. If you agree to take part in this study, your involvement from start to finish will last for approximately 5 years. You will be asked to visit the clinic several times during the Imaging Stage of the study (including a screening visit). In some instances, you may have the option to have a phone call instead of visiting the clinic. You may be in screening for up to 14 days before beginning the Imaging Stage, but the study doctor will try to complete the screening assessments as soon as possible. The Imaging Stage will evaluate your HCC tumor for GPC3 expression to determine if you can proceed to the Study Treatment Stage. If you are eligible to enroll to the Study Treatment Stage, you may be asked to visit the clinic up to several times. You may have the option to have a phone call and have your blood samples taken at a local laboratory, instead of visiting the clinic, if there are no procedures that require you to be at the clinic and if your clinic is able to do this. Discuss with your study doctor which visits you could do via a phone call. You will have 1 visit to the clinic when you finish treatment or discontinue from the study. If you receive at least 1 dose of RYZ801, you will enter the Long-Term Follow-Up period following the Study Treatment Stage. During Long-Term Follow-Up, you will be followed up with every 3 months via phone or office visits until your study participation ends. The study drugs, RYZ811 and RYZ801, will be provided by the sponsor at no cost to you. All additional study procedures that are beyond your standard medical care, including laboratory tests, physical examinations, and visits to the study center, are provided to you at no charge. Additional information can be found here: https://clinicaltrials.gov/study/NCT06726161 [email protected]