Un protocole de traitement d'accès élargi au zanidatamab (ZW25) chez les patients atteints d'un cancer avancé des voies biliaires HER2-positif
Accès élargi Utilisation du Zanidatamab pour le traitement de la tumeur solide avancée HER2-positive
This is an intermediate-size Expanded Access Protocol (EAP) for use of zanidatamab (ZW25) in patients with human epidermal growth factor receptor 2 (HER2)-positive advanced biliary tract cancer (BTC) who are not eligible for other zanidatamab clinical trials, and who in the opinion of the treating oncologist, would potentially benefit from treatment with zanidatamab.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Type d'accès étendu
- Population de taille intermédiaire
Contacts et emplacements
Lieux d'étude
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Barcelona, Espagne, 08035
- Vall D'Hebron University Hospital
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Madrid, Espagne, 28041
- Hospital Universitario 12 de Octubre
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Madrid, Espagne, 28040
- Fundacion Jimenez Diaz University Hospital - Autonomous University of Madrid
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Besançon, France, 25030
- Jean Minjoz Hospital
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Marseille, France, 13385
- Hopital Timone Marseille
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Pessac, France, 33604
- Hopital Haut-Leveque - CHU Bordeaux
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Villejuif, France, 94805
- Gustave Roussy Cancer Center
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Candiolo, Italie, 10060
- ICCRS Candiolo
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Milan, Italie, 20133
- Istituto Nazionale Tumori
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Milan, Italie, 20072
- Istituto Clinico Humanitas
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Harlow, Royaume-Uni, CM20 1QX
- The Princess Alexandra Hospital NHS Trust (Joanne Kwa, Pharmacist)
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London, Royaume-Uni, WC1E 6AG
- UCLH Cancer Institute (Meera Desai, Pharmacist)
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London, Royaume-Uni, WC1E 6JA
- HCA Healthcare UK
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Arizona
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Gilbert, Arizona, États-Unis, 85234
- NoCo Banner MD Anderson Cancer Center
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California
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Cerritos, California, États-Unis, 90603
- TOI Clinical Research
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Salinas, California, États-Unis, 93901
- Salinas Valley Memorial Healthcare System
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Missouri
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St Louis, Missouri, États-Unis, 63110
- Washington University School of Medicine
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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:
- Histologically confirmed HER2-positive locally advanced or metastatic biliary tract cancer that has progressed after receipt of available therapies known to confer clinical benefit.
- Adequate cardiac left ventricular function, as defined by left ventricular ejection fraction (LVEF) ≥ 50%
- Adequate organ function
- Ineligible to participate or has no access to an ongoing zanidatamab or other Zymeworks clinical study (e.g., ZW49 clinical study).
- Females of childbearing potential and non-sterile males must agree to practice highly effective methods of birth control for the duration of the study and for 12 months after the last dose of study drug. In addition, non-sterile males must avoid sperm donation for the duration of the study and for 12 months after the last dose of study drug.
Exclusion Criteria:
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Participating in other studies involving investigational drug(s) ≤ 3 weeks before the first dose of zanidatamab.
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Systemic anti-cancer therapy ≤ 3 weeks before the first dose of zanidatamab.
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Radiotherapy ≤ 2 weeks of the first dose of zanidatamab
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The following central nervous system (CNS) brain lesions are excluded from the study:
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Untreated or unstable brain lesions requiring immediate local therapy or symptomatic CNS metastases.
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Radiation treatment for CNS metastases within 4 weeks before the first dose of zanidatamab.
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Known history of or ongoing leptomeningeal disease (LMD). If LMD has been reported radiographically, but is not suspected clinically by the investigator, the patient must be free of neurological symptoms of LMD.
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The following CNS brain lesions are permitted:
- Stable brain lesions are permitted if stable, as defined by patients who are off steroids and anticonvulsants and are neurologically stable with no evidence of radiographic progression for at least 4 weeks at the time of screening.
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Concurrent uncontrolled or active hepatobiliary disorders or untreated or ongoing complications after laparoscopic procedures or stent placement, including but not limited to active cholangitis, unresolved biliary obstruction, biloma or abscess. Any complications should be resolved within 2 weeks prior to the first dose of zanidatamab.
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Active hepatitis
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Infection with human immunodeficiency virus (HIV) with uncontrolled disease.
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Females who are breastfeeding or pregnant, and females and males planning a pregnancy.
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History of myocardial infarction or unstable angina within 6 months prior to enrollment, congestive heart failure (NYHA Class 3 or 4), or clinically significant cardiac disease
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QTc Fridericia (QTcF) > 470 ms assessed within 30 days of screening
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Acute or chronic uncontrolled pancreatitis or Child-Pugh Class C liver disease
Plan d'étude
Comment l'étude est-elle conçue ?
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
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
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- ZWI-ZW25-EAP
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