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RECRUITING
NCT03075696
PHASE1/PHASE2

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

View on ClinicalTrials.gov

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

Interventions

DRUG

Glofitamab

Glofitamab will be administered at a dose and as per the schedule specified in the respective arms.

DRUG

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.

DRUG

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