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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
Condition: Non-Hodgkin's Lymphoma · Sponsor: Hoffmann-La Roche
About this study
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.
This description comes directly from the study's public registry record.
Talk to the study team
No contact information is available for this study as per the public registry record.
Always discuss trial participation with your own doctor first.
Locations (34)
| 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 | — |
| 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 | — |
+ 22 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT03075696