Study on Using RYZ811 and RYZ801 to Identify and Treat Patients with Unresectable Liver Cancer (HCC)

Sponsor: RayzeBio, Inc.

Sponsor score: 0

ClinicalTrials ID:NCT06726161

This clinical trial is testing a new diagnostic and treatment approach using RYZ811 and RYZ801 for patients with liver cancer that cannot be surgically removed. The study aims to determine the effectiveness and safety of this new method.

Patient Parameters

Program Overview

This study is exploring a new way to diagnose and treat liver cancer that cannot be removed by surgery. It involves using a pair of drugs, RYZ811 for diagnosis and RYZ801 for treatment, to target liver cancer cells that have a specific marker called GPC3. The trial is open to adults with advanced liver cancer who have already tried other treatments without success. Researchers aim to find out if this new approach can help manage the disease more effectively.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of liver cancer (HCC).
  • Have advanced liver cancer that cannot be treated with local therapies.
  • Have good liver function (Child-Pugh A) and overall health (ECOG score 0-1).
  • Have experienced disease progression after one prior systemic therapy for liver cancer.
  • Have measurable cancer according to standard criteria.
  • Have good kidney and blood function.
  • Have recovered from any side effects of previous treatments.
  • If infected with hepatitis B or C, the disease must be managed according to local practices.
  • Previous treatment for stomach or esophageal varices is allowed if there is no significant bleeding.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception.
  • Sexually active men must use condoms and agree to use additional contraception if their partners are women of childbearing potential.

Exclusion Criteria

  • Have specific types of liver cancer like fibrolamellar carcinoma or sarcomatoid HCC.
  • Have had a liver transplant.
  • Have allergies to components of RYZ811 or RYZ801.
  • Have certain types of blood vessel involvement in the liver (Vp4).
  • Have had liver-related brain issues or significant fluid buildup in the abdomen recently.
  • Have had certain liver treatments recently.
  • Have untreated or unresolved brain metastases.
  • Have lung diseases like pulmonary fibrosis or pneumonitis.
  • Have uncontrolled health issues like high blood pressure or diabetes.
  • Have significant heart disease or have had significant bleeding issues.
  • Have participated in another clinical study recently.
  • Have other serious health conditions that could interfere with the study.
  • Have had another primary cancer in the last 3 years, except for certain treated cancers.
  • Are pregnant or breastfeeding.

Locations

FACILITYZIPCITYSTATE
Research Facility35233BirminghamAlabama
Research Facility85054PhoenixArizona
Research Facility85719TucsonArizona
Research Facility92868OrangeCalifornia
Research Facility32224JacksonvilleFlorida
Research Facility40536LexingtonKentucky
Research Facility21287BaltimoreMaryland
Research Facility55905RochesterMinnesota
Research Facility68130OmahaNebraska
Research Facility10065New YorkNew York

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