Une étude de ZW251 chez les participants atteints de tumeurs solides avancées
Une étude multicentrique de première humanité, phase 1, ouverte et multicentrique de ZW251, un nouveau conjugué Glypican-3 ciblant les anticorps, chez les participants avec des tumeurs solides avancées, y compris le carcinome hépatocellulaire
The purpose of this study is to find out if ZW251, an antibody-drug conjugate targeting glypican-3 (GPC3), is safe and can treat participants with advanced cancers, including hepatocellular carcinoma (HCC), squamous cell non-small cell lung cancer (NSCLC), or germ cell tumors (GCT).
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Part 1 (dose escalation) of the study will evaluate the safety and tolerability of ZW251 in HCC, squamous cell NSCLC, and GCT. Part 2 (dose optimization) of the study will further assess safety and potential anti-tumor activity of the ZW251 established recommended doses in HCC.
Type d'étude
Inscription (Estimé)
Phase
- La phase 1
Contacts et emplacements
Coordonnées de l'étude
- Nom: Zymeworks Clinical Trial Resource
- Numéro de téléphone: (206) 237-1030
- E-mail: medinfo@zymeworks.com
Lieux d'étude
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Barcelona, Espagne, 08035
- Recrutement
- Hospital Universitario Vall d'Hebron
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Chercheur principal:
- Jaume Capdevila Castillon, MD, PhD
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Barcelona, Espagne, 29010
- Recrutement
- START Barcelona
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Chercheur principal:
- Tatiana Hernandez Guerrero, MD, PhD
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Logroño, Espagne, 26006
- Recrutement
- START - Rioja Hospital Universitario San Pedro
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Chercheur principal:
- Maria Jose de Miguel Luken, MD
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Madrid, Espagne, 28223
- Recrutement
- NEXT Oncology Madrid
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Chercheur principal:
- Valentina Boni, MD, PhD
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Madrid, Espagne, 28050
- Recrutement
- START Madrid Hospital Universitario HM Sanchinarro - CIOCC
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Chercheur principal:
- Emiliano Calvo, MD, PhD
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Madrid, Espagne, 28040
- Recrutement
- START Madrid Hospital Universitario Fundacion Jimenez Diaz
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Chercheur principal:
- Manuel Pedregal Trujillo, MD
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Málaga, Espagne, 29010
- Recrutement
- Hospital Universitario Virgen de la Victoria
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Chercheur principal:
- Javier Garcia Corbacho, MD
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Pamplona, Espagne, 31008
- Recrutement
- Clinica Universidad de Navarra
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Chercheur principal:
- Bruno Sangro, MD, PhD
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Dublin, Irlande, D07 R2WY
- Recrutement
- START - Dublin Mater Misericordiae University Hospital (MMUH)
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Chercheur principal:
- Austin Duffy, MD, DMed
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Kashiwa, Japon, 2778577
- Recrutement
- National Cancer Center East
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Chercheur principal:
- Masafumi Ikeda, MD, PhD
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Kyoto, Japon, 606-8507
- Recrutement
- Kyoto University Hospital
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Chercheur principal:
- Takako Nakajima, MD
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Osaka, Japon, 573-1191
- Recrutement
- Kansai Medical University Hospital
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Chercheur principal:
- Toshio Shimizu, MD, PhD
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Tokyo, Japon, 104-0045
- Recrutement
- National Cancer Center Hospital
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Chercheur principal:
- Yuta Maruki, MD
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Lisbon, Le Portugal, 1649-035
- Recrutement
- START Lisboa a - Unidade de Ensaios ClÃnicos - Hospital de Santa Maria
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Chercheur principal:
- Andre Mansinho, MD, MSc
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Vila Nova de Gaia, Le Portugal, 4434-502
- Recrutement
- Unidade Local de Saúde Gaia e Espinho
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Chercheur principal:
- Andreia Capela, MD
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Taipei, Taïwan, 100225
- Recrutement
- National Taiwan University Hospital
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Chercheur principal:
- Ann Lii Cheng, MD
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Taipei, Taïwan, 112201
- Recrutement
- Taipei Veterans General Hospital
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Chercheur principal:
- Yi-Hsiang Huang, MD, PhD
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California
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San Francisco, California, États-Unis, 94158
- Recrutement
- UCSF Comprehensive Cancer Center
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Chercheur principal:
- Katie Kelley, MD
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Santa Monica, California, États-Unis, 90404
- Recrutement
- University of California Los Angeles - Cancer Care - Santa Monica (UCLA)
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Chercheur principal:
- Richard Finn, MD
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Kentucky
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Louisville, Kentucky, États-Unis, 40202
- Recrutement
- Norton Cancer Institute
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Chercheur principal:
- John Hamm, MD FACP, FASCO
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Michigan
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Grand Rapids, Michigan, États-Unis, 49546
- Recrutement
- START Midwest
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Chercheur principal:
- Sreenivasa Chandana, MD, PhD
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New Jersey
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Hackensack, New Jersey, États-Unis, 07601
- Recrutement
- Hackensack University Medical Center
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Chercheur principal:
- Martin Gutierrez, MD
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New York
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New York, New York, États-Unis, 10065-6800
- Recrutement
- Memorial Sloan Kettering Cancer Center
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Chercheur principal:
- Ghassan Abou-Alfa, MD, JD, MBA, PhD
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Texas
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Houston, Texas, États-Unis, 77030
- Recrutement
- MD Anderson Cancer Center
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Chercheur principal:
- Ecaterina Dumbrava, MD
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San Antonio, Texas, États-Unis, 78229
- Recrutement
- START San Antonio
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Chercheur principal:
- Muralidhar Beeram, MD, MBBS
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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:
- Pathologically or cytologically confirmed diagnosis of HCC with evidence of locally advanced (unresectable, and ineligible for transplant) and/or metastatic disease. Noninvasive methods may be used to confirm diagnosis
- Pathologically or cytologically confirmed diagnosis of squamous cell NSCLC with evidence of locally advanced (unresectable) and/or metastatic disease
- Pathologically or cytologically confirmed diagnosis of GCT with evidence of yolk sac and/or choriocarcinoma predominant component and locally advanced (unresectable) and/or metastatic disease
- Measurable disease per RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
- Liver function status of Child-Pugh Class A (for HCC only)
- Adequate organ function
Exclusion Criteria:
- Known additional malignancy that is progressing or that has required active treatment within the last year
- History of hepatic encephalopathy within the past 6 months or requirement for medications to control encephalopathy
- Participants with HCC experiencing main portal vein tumor invasion require sponsor approval for enrollment
- Known gastrointestinal bleeding within 3 months
- Acute or chronic uncontrolled renal disease, pancreatitis, or non-malignant liver disease
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Zw251
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Administered intravenously |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Incidence of dose-limiting toxicities (DLTs; Part 1)
Délai: Up to 3 weeks
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Number of participants who experienced a DLT. DLTs include specifically defined adverse events (AEs) considered to be related to ZW251 |
Up to 3 weeks
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Incidence of AEs (Parts 1 and 2)
Délai: Up to approximately 2 years
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Number of participants who experienced AEs, adverse events of special interest, or serious adverse events |
Up to approximately 2 years
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Incidence of clinical laboratory abnormalities (Parts 1 and 2)
Délai: Up to approximately 2 years
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Number of participants who experienced a maximum severity of Grade 3 or higher post-baseline laboratory abnormality, including either hematology or chemistry. Grades are defined using National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 5.0 |
Up to approximately 2 years
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Objective response rate (Part 2)
Délai: Up to approximately 2 years
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Number of participants who achieved a best overall response of either confirmed complete response (CR) or partial response (PR) during treatment according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 |
Up to approximately 2 years
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Meilleure réponse globale (parties 1 et 2)
Délai: Jusqu'à environ 2 ans
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Jusqu'à environ 2 ans
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Objective response rate (Part 1)
Délai: Up to approximately 2 years
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Number of participants who achieved a best overall response of either confirmed CR or PR during treatment according to RECIST v1.1 |
Up to approximately 2 years
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Disease control rate (Parts 1 and 2)
Délai: Up to approximately 2 years
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Number of participants who achieved a best response of CR, PR, or stable disease during treatment per RECIST v1.1 |
Up to approximately 2 years
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Duration of response (Parts 1 and 2)
Délai: Up to approximately 2 years
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The time from the first objective response (CR or PR) to the first documented progressive disease (PD) per RECIST v1.1 or death within 30 days of last dose of study treatment from any cause. Only participants who achieve a confirmed response will be included in the analysis |
Up to approximately 2 years
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Progression-free survival (Part 2)
Délai: Up to approximately 2 years
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The time from the first dose of study treatment to the date of first documented PD per RECIST v1.1 or death from any cause |
Up to approximately 2 years
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Area under the concentration-time curve (AUC0-504) of ZW251 (Parts 1 and 2)
Délai: Up to approximately 2 years
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Area under the concentration-time curve of ZW251 after first dose administration |
Up to approximately 2 years
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Maximum concentration (Cmax) of ZW251 (Parts 1 and 2)
Délai: Up to approximately 2 years
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ZW251 maximum concentration after first dose administration |
Up to approximately 2 years
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Area under the concentration-time curve of ZW251 at steady state (AUCtau,ss; Parts 1 and 2)
Délai: Up to approximately 2 years
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Area under the concentration-time curve of ZW251 at steady state after fourth dose administration |
Up to approximately 2 years
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Maximum concentration of ZW251 at steady state (Сmax,ss; Parts 1 and 2)
Délai: Up to approximately 2 years
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ZW251 maximum concentration at steady state after fourth dose administration |
Up to approximately 2 years
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Minimal concentration of ZW251 at steady state (Сmin,ss; Parts 1 and 2)
Délai: Up to approximately 2 years
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ZW251 minimal concentration at steady state after fourth dose administration |
Up to approximately 2 years
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Incidence of anti-drug antibodies (ADAs; Parts 1 and 2)
Délai: Up to approximately 2 years
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Number of participants who develop ADAs |
Up to approximately 2 years
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Maggie Weinstein, MD, PhD, MPH, Zymeworks BC 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
- Tumeurs par site
- Tumeurs
- Maladies des voies respiratoires
- Tumeurs par type histologique
- Tumeurs du système digestif
- Maladies du système digestif
- Maladies pulmonaires
- Maladies du foie
- Tumeurs, glandulaires et épithéliales
- Adénocarcinome
- Tumeurs du foie
- Tumeurs des voies respiratoires
- Tumeurs thoraciques
- Carcinome
- Carcinome bronchique
- Tumeurs bronchiques
- Carcinome hépatocellulaire
- Tumeurs pulmonaires
- Carcinome pulmonaire non à petites cellules
- Tumeurs, cellules germinales et embryonnaires
- Tumeurs à cellules squameuses
Autres numéros d'identification d'étude
- ZWI-ZW251-101
- 2025-523088-39 (Numéro EudraCT)
- 2025 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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