Spots Global Cancer Trial Database for A Study Evaluating Safety, Pharmacokinetics, and Therapeutic Activity of RO6874281 as a Single Agent (Part A) or in Combination With Trastuzumab or Cetuximab (Part B or C)
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Trial Identification
Brief Title: A Study Evaluating Safety, Pharmacokinetics, and Therapeutic Activity of RO6874281 as a Single Agent (Part A) or in Combination With Trastuzumab or Cetuximab (Part B or C)
Official Title: An Open-Label, Multicenter, Dose-Escalation, Phase Ia/Ib Study to Evaluate Safety, Pharmacokinetics, and Therapeutic Activity of RO6874281, an Immunocytokine Consisting of Interleukin 2 Variant (IL-2v) Targeting Fibroblast Activation Protein-α (FAP), as a Single Agent (Part A) or in Combination With Trastuzumab or Cetuximab (Part B or C)
Study ID: NCT02627274
Study Description
Brief Summary: This first-in-human, open-label, multicenter, Phase Ia/Ib, adaptive, multiple ascending-dose study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary anti-tumor activity of RO6874281 as a single agent (Part A) or in combination with trastuzumab or cetuximab (Part B or C).
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Arizona Cancer Center, Tucson, Arizona, United States
UCSD - Moores Cancer Center, La Jolla, California, United States
Banner MD Anderson Cancer Center, Greeley, Colorado, United States
Washington University; Division of Oncology, Saint Louis, Missouri, United States
The Ohio State University, Columbus, Ohio, United States
UZ Antwerpen, Edegem, , Belgium
Juravinski Cancer Clinic; Department of Oncology, Hamilton, Ontario, Canada
Princess Margaret Cancer Center, Toronto, Ontario, Canada
Rigshospitalet; Onkologisk Klinik, København Ø, , Denmark
Institut Bergonie; Oncologie, Bordeaux, , France
Centre Georges Francois Leclerc, Dijon, , France
Centre Leon Berard, Lyon, , France
Institut Claudius Regaud; Departement Oncologie Medicale, Toulouse, , France
Institut Gustave Roussy; Sitep, VILLEJUIF Cedex, , France
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica, Meldola, Emilia-Romagna, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori;S.S. Trattamento MedicoTumori dellaTesta e delCollo, Milano, Lombardia, Italy
Istituto Europeo di Oncologia; Svil. Nuovi Farmaci per Terapie Innovative, Milano, Lombardia, Italy
Azienda Socio Sanitaria Territoriale Niguarda (Ospedale Niguarda Ca' Granda); Oncologico -Onc.Falck, Milano, Lombardia, Italy
Ospedale Policlinico S. Matteo; Phase I Clinical Trial Unit and Experimental Therapy, Pavia, Lombardia, Italy
Antoni Van Leeuwenhoek Ziekenhuis; Gastro-Enterologie, Amsterdam, , Netherlands
Erasmus MC, Rotterdam, , Netherlands
Clinica Universitaria de Navarra, Pamplona, Navarra, Spain
Hospital Univ Vall d'Hebron; Servicio de Oncologia, Barcelona, , Spain
Leicester Royal Infirmary, Leicester, , United Kingdom
Guys and St Thomas NHS Foundation Trust, Guys Hospital, London, , United Kingdom
Christie Hospital, Manchester, , United Kingdom
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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