GPC3+ 절제 불가능한 HCC가 있는 피험자를 식별하고 치료하기 위한 치료 쌍 RYZ811(진단) 및 RYZ801(치료)에 대한 연구 (GPC3)
GPC3+ 절제불가 간세포암종(HCC)이 있는 피험자를 식별하고 치료하기 위한 치료쌍 RYZ811(진단) 및 RYZ801(치료)의 단일군, 공개 라벨 시험 1/1b상
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)
연구 개요
연구 유형
등록 (추정된)
단계
- 2 단계
- 1단계
연락처 및 위치
연구 연락처
- 이름: RayzeBio Clinical Trials
- 전화번호: 1-619-657-0057
- 이메일: clinicaltrials@rayzebio.com
연구 장소
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Alabama
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Birmingham, Alabama, 미국, 35294
- 모병
- Research Facility
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Arizona
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Phoenix, Arizona, 미국, 85054
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- Research Facility
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California
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Orange, California, 미국, 92868
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- Research Facility
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Florida
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Jacksonville, Florida, 미국, 32224
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- Research Facility
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Kentucky
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Lexington, Kentucky, 미국, 40536
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- Research Facility
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Maryland
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Baltimore, Maryland, 미국, 21287
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- Research Facility
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Minnesota
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Rochester, Minnesota, 미국, 55905
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- Research Facility
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Missouri
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St Louis, Missouri, 미국, 63104
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- Research Facility
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Nebraska
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Omaha, Nebraska, 미국, 68130
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- Research Facility
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New York
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New York, New York, 미국, 10065
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- Research Facility
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Texas
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Houston, Texas, 미국, 77030
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- Research Facility
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Virginia
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Charlottesville, Virginia, 미국, 22908
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- Research Facility
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Washington
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Seattle, Washington, 미국, 98109
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- Research Facility
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
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Age of at least 18 years at the time of signing the informed consent form (ICF)
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Histologically/cytologically confirmed diagnosis of HCC.
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Barcelona Clinic Liver Cancer (BCLC) Stage C or BCLC Stage B not amenable to locoregional therapy
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Child-Pugh A
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Eastern Cooperative Oncology Group (ECOG) performance status (PS 0-1)
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Disease progression after 1 prior systemic therapy for unresectable HCC
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Measurable disease per RECIST v1.1
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Sufficient renal function
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Adequate hematologic function
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Adequate hepatic function
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The subject must have recovered from toxicities related to prior treatments to ≤Grade 1, unless clinically nonsignificant and/or stable on supportive therapy
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If HBV or HCV infection: Disease managed per local practice; antiviral treatment is allowed.
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Gastric or esophageal varices previously treated with endoscopic therapy according to institutional standards are permitted if no clinically significant bleeding
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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
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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:
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Subjects with fibrolamellar carcinoma, sarcomatoid HCC or combined hepatocellular cholangiocarcinoma
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Prior liver transplantation
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Known hypersensitivity to 68Ga, 225Ac or any of the excipients of RYZ811 or RYZ801
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Portal vein tumor thrombosis classified as Vp4
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Documented hepatic encephalopathy within 6 months of enrollment
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Clinically meaningful ascites within 6 months of enrollment
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Prior EBRT to the liver within 12 weeks prior to receiving RYZ811
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Prior liver radioembolization
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Previously treated central nervous system (CNS) metastasis without recovery from acute side effects
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Documented history of idiopathic pulmonary fibrosis (IPF), interstitial lung disease (ILD) or pneumonitis
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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
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History of clinically significant bleeding
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Prior participation in any interventional clinical study
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Current somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study
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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
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Subject requires other treatment that in the opinion of the Investigator would be more appropriate than what is offered in the study
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Pregnancy or breastfeeding
Note: Additional criteria may apply and will be assessed by the study site
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 순차적 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 용량 증량, 용량 확장 (용량 최적화/무작위 2상)
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Ga-68 Ac-225 |
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활성 비교기: 표준 치료(SoC) (무작위 2상)
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Ga-68 |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Therapeutic - RYZ801
기간: Rate of DLTs during the first 42 days of study treatment
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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
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Therapeutic - RYZ801
기간: From enrollment for up to three months or study discontinuation, whichever occurs first.
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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.
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Therapeutic - RYZ801
기간: From enrollment to 3months after randomization or study discontinuation, whichever occurs first.
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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.
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Diagnostic - RYZ811
기간: Baseline, pre-injection and post-injection up to 6 days post injection.
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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.
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Diagnostic - RYZ811
기간: RYZ811 biodistribution to be assessed on the day of injection.
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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.
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공동 작업자 및 조사자
스폰서
수사관
- 연구 책임자: Freddy Escorcia, MD, PhD, RayzeBio, Inc.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- RYZ801-101
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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