GPC3+ 切除不能 HCC 患者を特定し治療するための治療薬ペア RYZ811 (診断用) と RYZ801 (治療用) の研究 (GPC3)
GPC3+ 切除不能肝細胞癌 (HCC) 患者の特定と治療を目的とした治療薬ペア RYZ811 (診断用) と RYZ801 (治療用) の第 1/1b 相単群非盲検試験
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)
調査の概要
研究の種類
入学 (推定)
段階
- フェーズ2
- フェーズ 1
連絡先と場所
研究連絡先
- 名前：RayzeBio Clinical Trials
- 電話番号：1-619-657-0057
- メール：clinicaltrials@rayzebio.com
研究場所
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Alabama
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Birmingham、Alabama、アメリカ、35294
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- Research Facility
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Arizona
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Phoenix、Arizona、アメリカ、85054
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- Research Facility
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California
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Orange、California、アメリカ、92868
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- Research Facility
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Florida
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Jacksonville、Florida、アメリカ、32224
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Kentucky
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Lexington、Kentucky、アメリカ、40536
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- Research Facility
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Maryland
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Baltimore、Maryland、アメリカ、21287
- 募集
- Research Facility
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Minnesota
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Rochester、Minnesota、アメリカ、55905
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- Research Facility
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Missouri
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St Louis、Missouri、アメリカ、63104
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- Research Facility
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Nebraska
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Omaha、Nebraska、アメリカ、68130
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- Research Facility
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New York
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New York、New York、アメリカ、10065
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Texas
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Houston、Texas、アメリカ、77030
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- Research Facility
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Virginia
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Charlottesville、Virginia、アメリカ、22908
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- Research Facility
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Washington
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Seattle、Washington、アメリカ、98109
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- Research Facility
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：順次割り当て
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：用量漸増、用量拡張（用量最適化／無作為化第2相）
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Ga-68 Ac-225 |
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アクティブコンパレータ：標準治療（SoC）（ランダム化第2相）
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Ga-68 |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Therapeutic - RYZ801
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
スポンサー
捜査官
- スタディディレクター：Freddy Escorcia, MD, PhD、RayzeBio, Inc.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- RYZ801-101
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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