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

Recruiting now · Phase 1/Phase 2

Conditions studied: Hepatocellular Carcinoma (HCC)

In brief

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)

Key facts

Study ID: NCT06726161
Run by: RayzeBio, Inc.
People needed: 590
Starts: 2025-09-05
Expected to finish: 2031-06-01
Last updated by the study team: 2026-04-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
Adequate hematologic function
Adequate hepatic function
The subject must have recovered from toxicities related to prior treatments to ≤Grade 1, unless clinically nonsignificant and/or stable on supportive therapy
If HBV or HCV infection: Disease managed per local practice; antiviral treatment is allowed.
Gastric or esophageal varices previously treated with endoscopic therapy according to institutional standards are permitted if no clinically significant bleeding
For women of childbearing potential (WOCBP):
Negative serum pregnancy test within 48 hours prior to the first dose of RYZ811
Agreement to use barrier contraception and a second form of highly effective contraception
For sexually active males:
Must use a condom during intercourse
Male subjects whose sexual partners are WOCBP must also agree to use a second form of highly effective contraception
A condom is required to be used also by vasectomized men

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
Previously treated central nervous system (CNS) metastasis without recovery from acute side effects
Documented history of idiopathic pulmonary fibrosis (IPF), interstitial lung disease (ILD) or pneumonitis
Uncontrolled significant intercurrent illness including, but not limited to:
QT interval corrected for heart rate using Fridericia's formula (QTcF) >470 ms
Hemoglobin A1c (Hgb A1c) ≥8%
Uncontrolled hypertension
Dose Expansion only: Prior treatment with lenvatinib is exclusionary
Significant cardiovascular disease or heart failure
History of clinically significant bleeding
Prior participation in any interventional clinical study
Current somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study
Have a history of primary malignancy within the past 3 years other than (1) HCC, (2) adequately treated carcinoma in situ or non-melanoma carcinoma of the skin, (3) any other curatively treated malignancy that is not expected to require treatment for recurrence during participation in the study, or (4) an untreated cancer on active surveillance that may not affect the subject's survival status for >3 years
Subject requires other treatment that in the opinion of the Investigator would be more appropriate than what is offered in the study
Pregnancy or breastfeeding
Note: Additional criteria may apply and will be assessed by the study site

Where it is running

Research Facility — Birmingham, Alabama, United States (enrolling)
Research Facility — Phoenix, Arizona, United States (enrolling)
Research Facility — Tucson, Arizona, United States (enrolling)
Research Facility — Orange, California, United States (enrolling)
Research Facility — Jacksonville, Florida, United States (enrolling)
Research Facility — Lexington, Kentucky, United States (enrolling)
Research Facility — Baltimore, Maryland, United States (enrolling)
Research Facility — Rochester, Minnesota, United States (enrolling)
Research Facility — Omaha, Nebraska, United States (enrolling)
Research Facility — New York, New York, United States (enrolling)
Research Facility — Houston, Texas, United States (enrolling)
Research Facility — Charlottesville, Virginia, United States (enrolling)
Research Facility — Seattle, Washington, United States (enrolling)

Full record on ClinicalTrials.gov

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