Full Title
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)Purpose
Researchers want to find the best dose of RYZ801 to give with RYZ811 in people with inoperable liver cancer. Inoperable means the cancer cannot be taken out with surgery. The people in this study have hepatocellular carcinoma (HCC) that makes high levels of a liver protein called GPC3.
RYZ811 is an imaging drug that gives off a small amount of radiation and attaches to GPC3 on HCC cells. After you get RYZ811, a PET scanner takes images of your cancer. It detects the radioactivity from RYZ811, which lights up to show wherever the cancer is in your body.
RYZ801 is a radioactive targeted therapy. It is designed to target HCC cells with GPC3 and delivers radiation directly into the tumor, killing cancer cells. Both RYZ811 and RYZ801 are given intravenously (by vein).
Who Can Join
To join this study, there are a few conditions. You must:
- Have inoperable HCC that keeps growing after prior treatment and makes the GPC3 protein.
- Have recovered from the serious side effects of previous therapies before getting the study treatment.
- Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
- Be age 18 or older.
Contact
For more information about this study or to see if you can join, please call Dr. James Harding’s office at 646-888-4314.