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ACTIVE NOT RECRUITING
NCT03448042
PHASE1

A Study of Runimotamab in Participants With Locally Advanced or Metastatic HER2-Expressing Cancers

Sponsor: Genentech, Inc.

View on ClinicalTrials.gov

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

DRUG

Runimotamab

Runimotamab will be administered via IV infusion until disease progression, intolerable toxicity, or any other discontinuation criteria are met.

DRUG

Trastuzumab

Trastuzumab will be administered via IV infusion

DRUG

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