RecruitingHepatocellular Carcinoma (HCC)

Study of the Theranostic Pair RYZ811 (Diagnostic) and RYZ801 (Therapeutic) to Identify and Treat Subjects With GPC3+ (Glypican-3) Unresectable HCC

Eligible age

18+ yrs

Accepts

All genders

Locations

12 states

Healthy volunteers

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About this study

Phase 1/2 randomized, controlled, open-label trial of theranostic pair RYZ811 (diagnostic) and RYZ801 (therapeutic) to identify and treat subjects with GPC3+ unresectable hepatocellular carcinoma (HCC)

Sponsor: RayzeBio, Inc.

You may qualify if…

✓ Age of at least 18 years at the time of signing the informed consent form (ICF)
✓ Histologically/cytologically confirmed diagnosis of HCC.
✓ Barcelona Clinic Liver Cancer (BCLC) Stage C or BCLC Stage B not amenable to locoregional therapy
✓ Child-Pugh A
✓ Eastern Cooperative Oncology Group (ECOG) performance status (PS 0-1)
✓ Disease progression after 1 prior systemic therapy for unresectable HCC
✓ Measurable disease per RECIST v1.1
✓ Sufficient renal function

You may not qualify if…

✕ Subjects with fibrolamellar carcinoma, sarcomatoid HCC or combined hepatocellular cholangiocarcinoma
✕ Prior liver transplantation
✕ Known hypersensitivity to 68Ga, 225Ac or any of the excipients of RYZ811 or RYZ801
✕ Portal vein tumor thrombosis classified as Vp4
✕ Documented hepatic encephalopathy within 6 months of enrollment
✕ Clinically meaningful ascites within 6 months of enrollment
✕ Prior EBRT to the liver within 12 weeks prior to receiving RYZ811
✕ Prior liver radioembolization