NCT06726161 Study of the Theranostic Pair RYZ811 (Diagnostic) and RYZ801 (Therapeutic) to Identify and Treat Subjects With GPC3+ (Glypican-3) Unresectable HCC
| NCT ID | NCT06726161 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | RayzeBio, Inc. |
| Condition | Hepatocellular Carcinoma (HCC) |
| Study Type | INTERVENTIONAL |
| Enrollment | 590 participants |
| Start Date | 2025-09-05 |
| Primary Completion | 2030-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 590 participants in total. It began in 2025-09-05 with a primary completion date of 2030-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Contact & Investigator
Freddy Escorcia, MD, PhD
STUDY DIRECTOR
RayzeBio, Inc.
Frequently Asked Questions
Who can join the NCT06726161 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hepatocellular Carcinoma (HCC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06726161 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06726161 currently recruiting?
Yes, NCT06726161 is actively recruiting participants. Contact the research team at clinicaltrials@rayzebio.com for enrollment information.
Where is the NCT06726161 trial being conducted?
This trial is being conducted at Birmingham, United States, Phoenix, United States, Tucson, United States, Orange, United States and 9 additional locations.
Who is sponsoring the NCT06726161 clinical trial?
NCT06726161 is sponsored by RayzeBio, Inc.. The principal investigator is Freddy Escorcia, MD, PhD at RayzeBio, Inc.. The trial plans to enroll 590 participants.
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