Een uitgebreid toegangsprotocol van Zanidatamab (ZW25) bij patiënten met HER2-positieve gevorderde galwegkanker
Uitgebreid toegangsgebruik van Zanidatamab voor de behandeling van HER2-positieve geavanceerde solide tumor
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.
Studie Overzicht
Toestand
Interventie / Behandeling
Studietype
Uitgebreid toegangstype
- Bevolking van gemiddelde grootte
Contacten en locaties
Studie Locaties
-
-
-
Besançon, Frankrijk, 25030
- Jean Minjoz Hospital
-
Marseille, Frankrijk, 13385
- Hopital Timone Marseille
-
Pessac, Frankrijk, 33604
- Hopital Haut-Leveque - CHU Bordeaux
-
Villejuif, Frankrijk, 94805
- Gustave Roussy Cancer Center
-
-
-
-
-
Candiolo, Italië, 10060
- ICCRS Candiolo
-
Milan, Italië, 20133
- Istituto Nazionale Tumori
-
Milan, Italië, 20072
- Istituto Clinico Humanitas
-
-
-
-
-
Barcelona, Spanje, 08035
- Vall D'Hebron University Hospital
-
Madrid, Spanje, 28041
- Hospital Universitario 12 de Octubre
-
Madrid, Spanje, 28040
- Fundacion Jimenez Diaz University Hospital - Autonomous University of Madrid
-
-
-
-
-
Harlow, Verenigd Koninkrijk, CM20 1QX
- The Princess Alexandra Hospital NHS Trust (Joanne Kwa, Pharmacist)
-
London, Verenigd Koninkrijk, WC1E 6AG
- UCLH Cancer Institute (Meera Desai, Pharmacist)
-
London, Verenigd Koninkrijk, WC1E 6JA
- HCA Healthcare UK
-
-
-
-
Arizona
-
Gilbert, Arizona, Verenigde Staten, 85234
- NoCo Banner MD Anderson Cancer Center
-
-
California
-
Cerritos, California, Verenigde Staten, 90603
- TOI Clinical Research
-
Salinas, California, Verenigde Staten, 93901
- Salinas Valley Memorial Healthcare System
-
-
Missouri
-
St Louis, Missouri, Verenigde Staten, 63110
- Washington University School of Medicine
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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:
-
Participating in other studies involving investigational drug(s) ≤ 3 weeks before the first dose of zanidatamab.
-
Systemic anti-cancer therapy ≤ 3 weeks before the first dose of zanidatamab.
-
Radiotherapy ≤ 2 weeks of the first dose of zanidatamab
-
The following central nervous system (CNS) brain lesions are excluded from the study:
-
Untreated or unstable brain lesions requiring immediate local therapy or symptomatic CNS metastases.
-
Radiation treatment for CNS metastases within 4 weeks before the first dose of zanidatamab.
-
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.
-
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.
-
-
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.
-
Active hepatitis
-
Infection with human immunodeficiency virus (HIV) with uncontrolled disease.
-
Females who are breastfeeding or pregnant, and females and males planning a pregnancy.
-
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
-
QTc Fridericia (QTcF) > 470 ms assessed within 30 days of screening
-
Acute or chronic uncontrolled pancreatitis or Child-Pugh Class C liver disease
Studie plan
Hoe is de studie opgezet?
Medewerkers en onderzoekers
Sponsor
Studie record data
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- ZWI-ZW25-EAP
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .