此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

治疗诊断对 RYZ811（诊断）和 RYZ801（治疗）用于识别和治疗 GPC3+ 不可切除 HCC 受试者的研究 (GPC3)

2026年9月24日 更新者：RayzeBio, Inc.

治疗诊断对 RYZ811（诊断）和 RYZ801（治疗）的 1/1b 期单臂、开放标签试验，用于识别和治疗 GPC3+ 不可切除的肝细胞癌 (HCC) 受试者

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)

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

590

阶段

  • 阶段2
  • 阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 美国
    • Alabama
      • Birmingham、Alabama、美国、35294
        • 招聘中
        • Research Facility
    • Arizona
      • Phoenix、Arizona、美国、85054
        • 招聘中
        • Research Facility
    • California
      • Orange、California、美国、92868
        • 招聘中
        • Research Facility
    • Florida
      • Jacksonville、Florida、美国、32224
        • 招聘中
        • Research Facility
    • Kentucky
      • Lexington、Kentucky、美国、40536
        • 招聘中
        • Research Facility
    • Maryland
      • Baltimore、Maryland、美国、21287
        • 招聘中
        • Research Facility
    • Minnesota
      • Rochester、Minnesota、美国、55905
        • 招聘中
        • Research Facility
    • Missouri
      • St Louis、Missouri、美国、63104
        • 招聘中
        • Research Facility
    • Nebraska
      • Omaha、Nebraska、美国、68130
        • 招聘中
        • Research Facility
    • New York
      • New York、New York、美国、10065
        • 招聘中
        • Research Facility
    • Texas
      • Houston、Texas、美国、77030
        • 招聘中
        • Research Facility
    • Virginia
      • Charlottesville、Virginia、美国、22908
        • 招聘中
        • Research Facility
    • Washington
      • Seattle、Washington、美国、98109
        • 招聘中
        • Research Facility

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：顺序分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：剂量递增、剂量扩展（剂量优化/随机化第二阶段）
诊断测试：RYZ811

Ga-68

药品：RYZ801

Ac-225
有源比较器：标准治疗（SoC）（随机化第2阶段）
诊断测试：RYZ811

Ga-68

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Therapeutic - RYZ801
大体时间：Rate 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)
Rate of DLTs during the first 42 days of study treatment
Therapeutic - RYZ801
大体时间：From 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
From enrollment for up to three months or study discontinuation, whichever occurs first.
Therapeutic - RYZ801
大体时间：From 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
From enrollment to 3months after randomization or study discontinuation, whichever occurs first.
Diagnostic - RYZ811
大体时间：Baseline, 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.
Baseline, pre-injection and post-injection up to 6 days post injection.
Diagnostic - RYZ811
大体时间：RYZ811 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.
RYZ811 biodistribution to be assessed on the day of injection.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

RayzeBio, Inc.

调查人员

  • 研究主任：Freddy Escorcia, MD, PhD、RayzeBio, Inc.

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年9月5日

初级完成 (估计的)

2030年6月1日

研究完成 (估计的)

2031年6月1日

研究注册日期

首次提交

2024年11月5日

首先提交符合 QC 标准的

2024年12月4日

首次发布 (实际的)

2024年12月10日

研究记录更新

最后更新发布 (实际的)

2026年9月28日

上次提交的符合 QC 标准的更新

2026年9月24日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • RYZ801-101

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

订阅