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A Dose Escalation Study of Glofitamab (RO7082859) as a Single Agent and in Combination With Obinutuzumab, Administered After a Fixed, Single Pre-treatment Dose of Obinutuzumab in Participants With Relapsed/Refractory B-cell Non-hodgkin's Lymphoma
Sponsor: Hoffmann-La Roche
Summary
This is a Phase I/II, multicenter, open-label, dose-escalation study designed to evaluate the efficacy, safety, tolerability and pharmacokinetics (PK) of a novel T-Cell bispecific (TCB), glofitamab, administered by intravenous (IV) infusion as a single agent and in combination with obinutuzumab, following pre-treatment with a one-time, fixed dose of obinutuzumab. This entry-into-human (EIH) study is divided in 3 parts: dose escalation (Parts I and II) and dose expansion (Part III). Single-participant dose-escalation cohorts will be used in Part I, followed by conversion to multiple participant dose-escalation cohorts (Part II), in order to define a tentative maximum tolerated dose (MTD) or optimal biological dose (OBD). The expansion cohorts (Part III) will be initiated when the tentative MTD/OBD is defined, to further evaluate the safety, PK and therapeutic activity of glofitamab.
Official title: A Multicenter, Open-label, Phase I/II Study to Evaluate the Safety, Efficacy, Tolerability and Pharmacokinetics of Escalating Doses of Glofitamab (RO7082859) as a Single Agent and in Combination With Obinutuzumab Administered After a Fixed, Single Dose Pre-treatment of Obinutuzumab (Gazyva®/Gazyvaro™) in Patients With Relapsed/Refractory B-cell Non-hodgkin's Lymphoma
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
940
Start Date
2017-02-21
Completion Date
2029-12-31
Last Updated
2026-04-03
Healthy Volunteers
No
Conditions
Interventions
Glofitamab
Glofitamab will be administered at a dose and as per the schedule specified in the respective arms.
Obinutuzumab
Obinutuzumab 1000 mg single dose IV infusion on Day -7; or 2000 mg single dose administered on Day -7, or split into two 1000 mg doses administered on Days -1 and -7, and per the schedule specified in the respective arms.
Tocilizumab
Tocilizumab will be administered as an IV infusion, if required, for the management of severe Cytokine Release Syndrome (CRS) occurring during or after any infusion of glofitamab, as per the methods described in the Summary of Product Characteristics (SmPC) or other similar local prescribing documents.
Locations (38)
Ingalls Memorial Hospital
Harvey, Illinois, United States
University of Michigan
Ann Arbor, Michigan, United States
Washington University
St Louis, Missouri, United States
Mount Sinai Medical Center
New York, New York, United States
MSKCC
New York, New York, United States
Allegheny Health Network (Pittsburg PA)
Pittsburgh, Pennsylvania, United States
Hunstman Cancer Institute
Salt Lake City, Utah, United States
Swedish Cancer Inst.
Seattle, Washington, United States
Prince of Wales Hospital
Randwick, New South Wales, Australia
Peter Maccallum Cancer Centre
Melbourne, Victoria, Australia
Cliniques Universitaires St-Luc
Brussels, Belgium
UZ Gent
Ghent, Belgium
Princess Margaret Cancer Center
Toronto, Ontario, Canada
Vseobecna Fakultni Nemocnice v Praze, I. Interni Klinika - Klinika Hematoonkologie VFN a 1. LF UK
Prague, Czechia
Rigshospitalet
København Ø, Denmark
Helsinki University Central Hospital
Helsinki, Finland
Hopital Henri Mondor
Créteil, France
Hopital Claude Huriez
Lille, France
CHU Saint Eloi
Montpellier, France
Ch Lyon Sud
Pierre-Bénite, France
CHU DE RENNES - CHU Pontchaillou
Rennes, France
AUSL della Romagna
Ravenna, Emilia-Romagna, Italy
Fond. IRCCS Istituto Nazionale Tumori
Milan, Lombardy, Italy
Istituto Clinico Humanitas
Rozzano, Lombardy, Italy
A.O.U. Citta' Della Salute E Della Scienza-P.O. Molinette
Turin, Piedmont, Italy
Auckland Cancer Trial Centre
Auckland, New Zealand
Uniwersyteckie Centrum Kliniczne
Gda?sk, Poland
Uniwersytecki Szpital Kliniczny w Poznaniu
Późna, Poland
Centrum Onkologii-Instytut im. M. Sklodowskiej-Curie
Warsaw, Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
Wroc?aw, Poland
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital Duran i Reynals L'Hospitalet
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, Spain
Hospital del Mar
Barcelona, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Hospital Univ. 12 de Octubre
Madrid, Spain
China Medical University Hospital
Taichung, Taiwan
National Taiwan Universtiy Hospital
Taipei, Taiwan