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A Study of Runimotamab in Participants With Locally Advanced or Metastatic HER2-Expressing Cancers
Sponsor: Genentech, Inc.
Summary
This study will evaluate the safety, tolerability, and pharmacokinetics of Runimotamab administered intravenously as a single agent and in combination with Trastuzumab in participants with locally advanced or metastatic Human Epidermal Growth Factor Receptor 2 (HER2)-expressing cancers.
Official title: A Phase Ia/Ib, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of Runimotamab Administered Intravenously as a Single Agent and in Combination With Trastuzumab in Patients With Locally Advanced or Metastatic HER2-Expressing Cancers
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
123
Start Date
2018-06-06
Completion Date
2026-11-30
Last Updated
2026-02-27
Healthy Volunteers
No
Conditions
Interventions
Runimotamab
Runimotamab will be administered via IV infusion until disease progression, intolerable toxicity, or any other discontinuation criteria are met.
Trastuzumab
Trastuzumab will be administered via IV infusion
Tocilizumab
Participants will receive IV tocilizumab if needed
Locations (27)
Yale University
New Haven, Connecticut, United States
Washington University
Saint Louis, Michigan, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
SCRI Oncology Partners
Nashville, Tennessee, United States
MD Anderson Cancer Center
Houston, Texas, United States
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Grand Hopital de Charleroi asbl
Charleroi, Belgium
Princess Margaret Hospital
Toronto, Ontario, Canada
Rigshospitalet-Blegdamsvej 9
Copenhagen, Denmark
EDOG - Institut Bergonie - PPDS
Bordeaux, Gironde, France
Centre Léon Bérard
Lyon, Rhône, France
Gustave Roussy
Villejuif, Val-de-Marne, France
Institut Claudius Regaud
Toulouse, France
ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda Ca' Granda
Milan, Lombardy, Italy
National Cancer Center East
Chiba, Japan
Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis
Amsterdam, Netherlands
National Cancer Centre
Singapore, Singapore
Asan Medical Center
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcón, Madrid, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Spain
START MADRID_Hospital Universiario Fundacion Jimenez Diaz
Madrid, Spain
START MADRID_Hospital Universitario HM Sanchinarro - CIOCC - EDOS
Madrid, Spain
Hospital Clinico Universitario de Valencia
Valencia, Spain
China Medical University Hospital
Taichung, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Churchill Hospital
Oxford, Oxfordshire, United Kingdom