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New treatment option for Hepatocellular Carcinoma (HCC)
Official title Study of the Theranostic Pair RYZ811 (Diagnostic) and RYZ801 (Therapeutic) to Identify and Treat Subjects With GPC3+ (Glypican-3) Unresectable HCC
ClinicalTrials.gov ID: NCT06726161
What this study is testing
What is RYZ801?
RYZ801 is an investigational medicine, being studied as a potential treatment for hepatocellular carcinoma (hcc).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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)
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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)
You likely can't join if
- people 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
See the full eligibility 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 people 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
- people 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 treatment 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Phoenix, Arizona, United States
- Tucson, Arizona, United States
- Orange, California, United States
- Jacksonville, Florida, United States
- Lexington, Kentucky, United States
- Baltimore, Maryland, United States
- Rochester, Minnesota, United States
- Omaha, Nebraska, United States
- New York, New York, United States
- Houston, Texas, United States
- Charlottesville, Virginia, United States
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Phoenix, Arizona, United States; Tucson, Arizona, United States; Orange, California, United States; Jacksonville, Florida, United States; Lexington, Kentucky, United States and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.