Étude de la paire théranostique RYZ811 (diagnostique) et RYZ801 (thérapeutique) pour identifier et traiter des sujets atteints de CHC non résécable GPC3+ (GPC3)
Essai ouvert de phase 1/1b à un seul bras portant sur la paire théranostique RYZ811 (diagnostique) et RYZ801 (thérapeutique) pour identifier et traiter les sujets atteints d'un carcinome hépatocellulaire (CHC) non résécable GPC3+
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)
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- Phase 2
- La phase 1
Contacts et emplacements
Coordonnées de l'étude
- Nom: RayzeBio Clinical Trials
- Numéro de téléphone: 1-619-657-0057
- E-mail: clinicaltrials@rayzebio.com
Lieux d'étude
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Alabama
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Birmingham, Alabama, États-Unis, 35294
- Recrutement
- Research Facility
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Arizona
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Phoenix, Arizona, États-Unis, 85054
- Recrutement
- Research Facility
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California
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Orange, California, États-Unis, 92868
- Recrutement
- Research Facility
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Florida
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Jacksonville, Florida, États-Unis, 32224
- Recrutement
- Research Facility
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Kentucky
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Lexington, Kentucky, États-Unis, 40536
- Recrutement
- Research Facility
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Maryland
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Baltimore, Maryland, États-Unis, 21287
- Recrutement
- Research Facility
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Minnesota
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Rochester, Minnesota, États-Unis, 55905
- Recrutement
- Research Facility
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Missouri
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St Louis, Missouri, États-Unis, 63104
- Recrutement
- Research Facility
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Nebraska
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Omaha, Nebraska, États-Unis, 68130
- Recrutement
- Research Facility
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New York
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New York, New York, États-Unis, 10065
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- Research Facility
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Texas
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Houston, Texas, États-Unis, 77030
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- Research Facility
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Virginia
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Charlottesville, Virginia, États-Unis, 22908
- Recrutement
- Research Facility
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Washington
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Seattle, Washington, États-Unis, 98109
- Recrutement
- Research Facility
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation séquentielle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Dose Escalation, Dose Expansion (Dose Optimization/Randomized Phase 2)
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Ga-68 Ac-225 |
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Comparateur actif: Standard de Soins (SoC) (Phase 2 Randomisée)
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Ga-68 |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Therapeutic - RYZ801
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Freddy Escorcia, MD, PhD, RayzeBio, Inc.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Processus pathologiques
- Tumeurs par site
- Tumeurs
- Tumeurs par type histologique
- Tumeurs du système digestif
- Maladies du système digestif
- Maladies du foie
- Tumeurs, glandulaires et épithéliales
- Adénocarcinome
- Tumeurs du foie
- Carcinome
- Conditions pathologiques, signes et symptômes
- Carcinome hépatocellulaire
- Maladie
Autres numéros d'identification d'étude
- RYZ801-101
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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