Glofitamab
DrugGlofitamab will be administered at a dose and as per the schedule specified in the respective arms.
Other names: RO7082859
NCT Number: NCT03075696
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 study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Phase 1 / Phase 2
Prince of Wales Hospital, Randwick, New South Wales, Australia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Glofitamab will be administered at a dose and as per the schedule specified in the respective arms.
Other names: RO7082859
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.
Other names: RO5072759, GA101, Gazyva®, Gazyvaro™
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.
Other names: Actemra®, Roactemra®
Time frame: From Baseline up to 4 weeks
Time frame: From Baseline up to 90 days after last dose of study drug or until study completion or participant withdrawal (up to 5 years)
Time frame: From Baseline up to 4 weeks
Time frame: From Baseline up to 5 years
Time frame: From treatment start up to 5 years
Time frame: At pre-defined intervals from Cycle 1 Day 1 to Day 71
Time frame: At pre-defined intervals from Cycle 1 Day 1 to Day 198
Time frame: At pre-defined intervals from Cycle 1 Day 1 up to Day 198
Time frame: At pre-defined intervals from Cycle 1 Day 1 to Day 71
Time frame: At pre-defined intervals from Cycle 1 Day 1 to Day 71
Time frame: At pre-defined intervals from Cycle 1 Day 1 to Day 71
Time frame: Pre-dose of obinutuzumab on Day -7; pre-dose (Hr 0) of glofitamab on Day 1 of Cycle 1
Time frame: Pre-dose of obinutuzumab on Day -7; pre-dose (Hr 0) of glofitamab on Day 1 of Cycle 1
Time frame: Pre-dose of obinutuzumab on Day -7; pre-dose (Hr 0) of glofitamab on Day 1 of each cycle from Cycle 2 onwards for a maximum of 8-12 cycles, and at EOT/follow-up visit (up to 5 years)
Time frame: From Baseline up to end of study or discontinuation due to disease progression (up to 5 years)
Time frame: From Baseline up to end of study or discontinuation due to disease progression (up to 5 years)
Time frame: From first occurrence of documented objective response until disease progression, relapse or death due to any cause (up to 5 years)
Time frame: From the first occurrence of a documented, complete response, until the time of relapse or death from any cause (up to 5 years)
Time frame: From first study treatment to the first occurrence of disease progression or death due to any cause (up to 5 years)
Time frame: From the time of first study treatment to death from any cause (up to 5 years)
Time frame: From time of treatment start to first documented response (up to 5 years)
Time frame: From treatment start to first documented complete response (up to 5 years)
Time frame: From baseline through follow-up or until disease progression (up to 5 years)
Time frame: From baseline through follow-up or until disease progression (up to 5 years)
Hoffmann-La Roche
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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