Actively Recruiting
Study of the Theranostic Pair RYZ811 (Diagnostic) and RYZ801 (Therapeutic) to Identify and Treat Subjects With GPC3+ (Glypican-3) Unresectable HCC
Led by RayzeBio, Inc. · Updated on 2026-04-13
590
Participants Needed
13
Research Sites
299 weeks
Total Duration
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AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
Study of the Theranostic Pair RYZ811 (Diagnostic) and RYZ801 (Therapeutic) to Identify and Treat Subjects With GPC3+ (Glypican-3) Unresectable HCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age of at least 18 years at the time of signing the informed consent form
- Histologically or cytologically confirmed diagnosis of hepatocellular carcinoma (HCC)
- Barcelona Clinic Liver Cancer (BCLC) Stage C or Stage B not suitable for locoregional therapy
- Child-Pugh score A
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Disease progression after one prior systemic therapy for unresectable HCC
- Measurable disease according to RECIST v1.1 criteria
- Sufficient kidney function
- Adequate blood and liver function
- Recovery from prior treatment toxicities to Grade 1 or less unless stable on supportive therapy
- If infected with HBV or HCV, disease managed according to local practice and antiviral treatment allowed
- Previously treated gastric or esophageal varices without significant bleeding
- For women of childbearing potential: negative pregnancy test within 48 hours prior to first dose and agreement to use two forms of effective contraception
- For sexually active males: agreement to use condom and partner to use a second form of effective contraception; condom use required even if vasectomized
You will not qualify if you...
- Fibrolamellar carcinoma, sarcomatoid HCC, or combined hepatocellular cholangiocarcinoma
- Prior liver transplant
- Known allergy to Ga-68, Ac-225, or any ingredients in RYZ811 or RYZ801
- Portal vein tumor thrombosis classified as Vp4
- Hepatic encephalopathy within 6 months before enrollment
- Significant ascites within 6 months before enrollment
- Prior external beam radiation therapy to the liver within 12 weeks before RYZ811
- Prior liver radioembolization
- Untreated or unresolved central nervous system metastasis
- History of idiopathic pulmonary fibrosis, interstitial lung disease, or pneumonitis
- Uncontrolled illnesses such as prolonged QTc interval over 470 ms, high hemoglobin A1c (≥8%), uncontrolled hypertension, significant cardiovascular disease, or heart failure
- Prior lenvatinib treatment for dose expansion participants
- History of significant bleeding
- Previous participation in any interventional clinical trial
- Current somatic or psychiatric conditions interfering with study participation
- History of other primary cancers within 3 years except certain treated or monitored malignancies
- Need for other treatments deemed more appropriate by the investigator
- Pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 13 locations
1
Research Facility
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Research Facility
Phoenix, Arizona, United States, 85054
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3
Research Facility
Tucson, Arizona, United States, 85719
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4
Research Facility
Orange, California, United States, 92868
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5
Research Facility
Jacksonville, Florida, United States, 32224
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6
Research Facility
Lexington, Kentucky, United States, 40536
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7
Research Facility
Baltimore, Maryland, United States, 21287
Actively Recruiting
8
Research Facility
Rochester, Minnesota, United States, 55905
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9
Research Facility
Omaha, Nebraska, United States, 68130
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10
Research Facility
New York, New York, United States, 10065
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11
Research Facility
Houston, Texas, United States, 77030
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12
Research Facility
Charlottesville, Virginia, United States, 22908
Actively Recruiting
13
Research Facility
Seattle, Washington, United States, 98109
Actively Recruiting
Research Team
R
RayzeBio Clinical Trials
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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