RecruitingPhase 1Phase 2NCT06726161

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

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.

Enrollment

590 participants

Start Date

Sep 5, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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)


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests RYZ801 (a targeted radiation therapy) and its diagnostic partner RYZ811 (an imaging agent) in patients with advanced liver cancer (HCC) whose tumors express the GPC3 protein, offering a 'theranostic' approach — diagnose and treat with matched tools. **You may be eligible if...** - Age 18 or older - Have advanced liver cancer (hepatocellular carcinoma) confirmed by biopsy or cytology - Have advanced-stage disease (BCLC Stage C, or Stage B not suitable for local treatments) - Have preserved liver function (Child-Pugh A) - Good performance status (ECOG 0–1) - At least one prior line of systemic therapy **You may NOT be eligible if...** - Liver function is too impaired (Child-Pugh B or C) - Have had certain prior liver-directed or systemic treatments that are excluded - Cancer has spread to the brain - Have serious heart, kidney, or autoimmune conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTRYZ811

Ga-68

DRUGRYZ801

Ac-225


Locations(13)

Research Facility

Birmingham, Alabama, United States

Research Facility

Phoenix, Arizona, United States

Research Facility

Tucson, Arizona, United States

Research Facility

Orange, California, United States

Research Facility

Jacksonville, Florida, United States

Research Facility

Lexington, Kentucky, United States

Research Facility

Baltimore, Maryland, United States

Research Facility

Rochester, Minnesota, United States

Research Facility

Omaha, Nebraska, United States

Research Facility

New York, New York, United States

Research Facility

Houston, Texas, United States

Research Facility

Charlottesville, Virginia, United States

Research Facility

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

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NCT06726161


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