A Multicentre, Open-Label, Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Escalating Doses of RO7082859, Administered After a Fixed, Single Dose of Obinutuzumab (Gazyva®/Gazyvaro™) in Patients With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma
This is a Phase I, multicentre, open-label, dose-escalation study designed to evaluate the
safety, tolerability and pharmacokinetics (PK) of a novel T-Cell bispecific (TCB),
RO7082859, administered by intravenous (IV) infusion, following the pretreatment
administration of a one-time, fixed dose of obinutuzumab. The 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 RO7082859.
View this trial on ClinicalTrials.gov
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