Spots Global Cancer Trial Database for Enapotamab Vedotin (HuMax-AXL-ADC) Safety Study in Patients With Solid Tumors
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Trial Identification
Brief Title: Enapotamab Vedotin (HuMax-AXL-ADC) Safety Study in Patients With Solid Tumors
Official Title: First-in-human, Open-label, Dose-escalation Trial With Expansion Cohorts to Evaluate Safety of Axl-specific Antibody-drug Conjugate (Enapotamab Vedotin, HuMax®-AXL-ADC) in Patients With Solid Tumors
Study ID: NCT02988817
Interventions
Study Description
Brief Summary: The purpose of the trial is to determine the maximum tolerated dose and to establish the safety profile of HuMax-AXL-ADC in a mixed population of patients with specified solid tumors
Detailed Description: The trial consists of two parts; a dose escalation part (phase I, first in-human (FIH)) and an expansion part (phase IIa). The dose escalation part has 2 dosing schedules: 1 dose every 3 weeks (1Q3W) dose regimen, and 3 doses every 4 weeks (3Q4W) dosing regimen. The Expansion part of the trial will further explore the recommended phase 2 dose and dosing regimens of HuMax-AXL-ADC as determined in dose escalation part.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Mayo Clinic - Phoenix, Phoenix, Arizona, United States
University of Colorado Hospital, Aurora, Colorado, United States
Yale University, Smilow Cancer Center at Yale New Haven Hospital, New Haven, Connecticut, United States
Mayo Clinic Jacksonville, Jacksonville, Florida, United States
Moffitt Cancer Center, Tampa, Florida, United States
Emory University School of Medicine, Winship Cancer Institute, Atlanta, Georgia, United States
University of Iowa, Iowa City, Iowa, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
Mayo Clinic Rochester, Rochester, Minnesota, United States
Washington University, Saint Louis, Missouri, United States
Roswell Park Comprehensive Cancer Center, Buffalo, New York, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone, New York, New York, United States
Herbert Irving Comprehensive Cancer Center, New York, New York, United States
Duke Cancer Institute, Durham, North Carolina, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
Mary Crowley Cancer Research Center, Dallas, Texas, United States
University of Texas MD Anderson Cancer Center, Houston, Texas, United States
University of Utah Huntsman Cancer Institute, Salt Lake City, Utah, United States
University of Wisconsin Carbone Cancer Center, Madison, Wisconsin, United States
Universitair Ziekenhuizen Leuven, Leuven, Flemish Brabant, Belgium
Institut Roi Albert II - Cliniques Universitaires Saint Luc, Bruxelles, , Belgium
Universitair Ziekenhuis Brussel - Oncologisch Centrum, Jette, , Belgium
Medische oncologie, Oncologisch Centrum - AZ Groeninge, Kortrijk, , Belgium
U.Z. Leuven Gasthuisberg, Department of General Medical Oncology, Leuven, , Belgium
CHU de Liège, Medical Oncology et. Domaine Universitaire du Sart Tilman, Liege, , Belgium
Rigshospitalet, Copenhagen University Hospital, Copenhagen, , Denmark
The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, Amsterdam, , Netherlands
Leiden University Medical Centre, Leiden, , Netherlands
Erasmus MC, Medical Oncology, Rotterdam, , Netherlands
UMC Utrecht Cancer Center, Utrecht, , Netherlands
Hospital Unversitario Vall D'hebron, Barcelona, , Spain
Oncologia Mèdica/ Medical Oncology Department Institut Catalá d'Oncologia (ICO), Barcelona, , Spain
University Hospital of Girona, Girona, , Spain
Hospital Universitario 12 Octubre Servicio de Oncologia Medica, Madrid, , Spain
Hospital Virgen de la Victoria, Málaga, , Spain
University Hospital Lozano Blesa, Aragón Health Research Institute (IIS Aragón), Zaragoza, , Spain
University College London Hospitals, London, , United Kingdom
The Christie NHS Foundation Trust Clinical Trials Unit, Manchester, , United Kingdom
Sir Bobby Robson Clinical Trials Unit at the Northern Centre for Cancer Care, Freeman Hospital, Newcastle, , United Kingdom
The Royal Marsden Hospital, Sutton, , United Kingdom
Contact Details
Name: Ignace Vergote, Professor
Affiliation: Universitair Ziekenhuizen Leuven
Role: PRINCIPAL_INVESTIGATOR
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