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Brief Title: Tisotumab Vedotin (HuMax®-TF-ADC) Safety Study in Patients With Solid Tumors
Official Title: First-in-human, Dose-escalating Safety Study of Tissue Factor Specific Antibody Drug Conjugate Tisotumab Vedotin (HuMax® TF ADC) in Patients With Locally Advanced and/or Metastatic Solid Tumors Known to Express Tissue Factor
Study ID: NCT02001623
Brief Summary: The purpose of the trial is to establish the tolerability of HuMax-TF-ADC in a mixed population of patients with specified solid tumors.
Detailed Description: The study is conducted in two parts. The dose escalation portion of the trial subjects are enrolled into cohorts at increasing dose levels of HuMax-TF-ADC in 21 day treatment cycles. In the Cohort Expansion part of the trial, will further explore the recommended phase 2 dose of HuMax-TF-ADC as determined in Part 1
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of California Irvine Medical Center (UCIMC), Orange, California, United States
Yale Cancer Center, New Haven, Connecticut, United States
University of Miami, Miami, Florida, United States
University Gynecologic Oncology, Atlanta, Georgia, United States
Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States
Sarah Cannon Research Institute, Nashville, Tennessee, United States
MD Anderson Cancer Center, Houston, Texas, United States
University of Virginia, Charlottesville, Virginia, United States
Universitair Ziekenhuis Antwerpen, Edegem, Antwerpen, Belgium
Universitair Ziekenhuis Leuven, Leuven, Flemish Brabant, Belgium
Grand Hôpital de Charleroi, Charleroi, Hainaut, Belgium
Centre Hospitalier Universitaire Ambroise Paré, Mons, Hainaut, Belgium
CHU UCL Namur - site Godinne, Yvoir, Namur, Belgium
Saint-Luc University Hospital, Brussels, , Belgium
CHU de Liège, Liège, , Belgium
CHU UCL Namur - Sainte Elisabeth, Namur, , Belgium
Rigshospitalet, Copenhagen University Hospital, Copenhagen, , Denmark
Herlev and Gentofte Hospital, Herlev, , Denmark
Karolinska Universitetssjukhuset, Stockholm, Solna, Sweden
Lungemedicinska Kliniken, Linköping, , Sweden
The Leeds Teaching Hospitals NHS Trust, Leeds, England, United Kingdom
University College London Hospitals, London, England, United Kingdom
Sarah Cannon Research Institute - London, London, England, United Kingdom
Newcastle Hospitals NHS Foundation Trust, Newcastle upon Tyne, Newcastle, United Kingdom
The Royal Marsden NHS Foundation Trust, Sutton, Surrey, United Kingdom
Velindre NHS Trust, Cardiff, Wales, United Kingdom
Beatson Cancer Centre, Glasgow, , United Kingdom
Guys hospital, London, , United Kingdom
The Christie NHS Foundation Trust, Manchester, , United Kingdom
Name: Johann de Bono, Professor
Affiliation: The Institute of Cancer Research & The Royal Marsden NHS Foundation Trust
Role: PRINCIPAL_INVESTIGATOR