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Phase 1/2 Study of RYZ811 and RYZ801 for Unresectable Liver Cancer

This study is testing two new treatments, RYZ811 (a diagnostic test) and RYZ801 (a therapeutic drug), for people with unresectable hepatocellular carcinoma (HCC), a type of liver cancer. You might be able to join if you are at least 18 years old, have HCC that has progressed after one prior treatment, and meet other specific health criteria. The researchers want to see how safe RYZ801 is and how well it works over the first 42 days, and then for up to three months after you start treatment or until you stop the study. The current recruitment status is unclear.

Study design
This is a Phase 1/2 randomized, controlled, open-label study involving up to 590 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for up to three months after starting treatment or until you leave the study, whichever comes first.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06726161

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
RayzeBio, Inc.
~590 participants
Updated 2026-04-13 on ClinicalTrials.gov
What's tested:RYZ811RYZ801

At a glance

Recruiting sites
13 of 13 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Therapeutic - RYZ801
Measured over Rate of DLTs during the first 42 days of study treatment
+4 more outcomes measured

Conditions

Hepatocellular Carcinoma (HCC)

Explore related trials

Hepatocellular CarcinomaGlypican-3

Where it's being run

13 sites across 12 states
Arizona2
Alabama1
California1
Florida1
Kentucky1
Maryland1
Minnesota1
Nebraska1

Study leadership

  • Freddy Escorcia, MD, PhD · STUDY_DIRECTOR · RayzeBio, Inc.

Who to contact

RayzeBio Clinical Trials
[email protected]
1-619-657-0057
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Therapeutic - RYZ801Rate of DLTs during the first 42 days of study treatment

    To determine the RTA of RYZ801 in subjects with GPC3+ unresectable HCC (Dose Escalation only)

  • Therapeutic - RYZ801From enrollment for up to three months or study discontinuation, whichever occurs first.

    To determine if treatment with RYZ801, compared to SoC therapy, improves ORR in subjects with GPC3+ unresectable HCC (Dose Expansion Stage 2 only) using ORR (rate of CR or PR), as determined by BICR according to RECIST v1.1

  • Therapeutic - RYZ801From enrollment to 3months after randomization or study discontinuation, whichever occurs first.

    To evaluate ORR of RYZ801 different dosing regimens (Dose Expansion Stage 1 only) and determine dosage optimized RP2D using ORR (rate of confirmed CR or PR) by RECIST v1.1 per investigator assessment

  • Diagnostic - RYZ811Baseline, pre-injection and post-injection up to 6 days post injection.

    To assess the safety and tolerability of RYZ811 in subjects with unresectable HCC. Safety and tolerability of RYZ811 as measured by incidence and severity of AEs, including SAEs, laboratory changes, and other safety findings.

  • Diagnostic - RYZ811RYZ811 biodistribution to be assessed on the day of injection.

    To evaluate the biodistribution of RYZ811 in subjects with unresectable HCC. SUV (mean, maximum and peak) of organs and tumors; volume of RYZ811 avid uptake in tumor lesions; and tumor-to-normal organ tracer uptake ratios.