Glofitamab
DrugGlofitamab will be administered intravenously (IV) as a step-up dose for Cycle 2 on Days 8 and 15, and as a single dose from Cycle 3 onwards.
Other names: RO7082859
NCT Number: NCT03467373
This is a phase 1B, multi-center, dose-finding study of glofitamab administered in combination with obinutuzumab (Gazyva; [G]), rituximab (R) and standard doses of CHOP (G/R-CHOP or R-CHOP) in participants with r/r NHL and G/R CHOP or Pola-R-CHP in participants with untreated diffuse large B-cell lymphoma (DLBCL). Evaluating the safety, preliminary activity, pharmacokinetic (PK), and pharmacodynamic effects of this combination will be the main objectives of this study. The study is divided in two parts:
* Part I: Dose finding in participants with r/r NHL; test use of G vs R in Cycle 1 * Part II: Dose Expansion. The maximum tolerated dose or optimal biological dose (MTD or OBD) will be further assessed in participants with untreated DLBCL (>18 years of age with an age-adjusted International Prognostic Index (IPI) of 2-5). Glofitamab will be studied in combination with R-CHOP and Pola-R-CHP.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Phase 1
Peter Maccallum Cancer Centre, Melbourne, Victoria, Australia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Glofitamab will be administered intravenously (IV) as a step-up dose for Cycle 2 on Days 8 and 15, and as a single dose from Cycle 3 onwards.
Other names: RO7082859
Obinutuzumab 1000 mg single dose IV infusion on Day 1 of Cycle 1 only
Other names: Gazyva
Rituximab will be administered as an IV infusion at a dose of 375 mg/m^2 on Day 1 of each 21-day cycle starting from Cycle 1 to Cycle 6 (Part 1) or from Cycles 1-6 (up to 8) (Part 2: DLBCL R-CHOP).
Other names: Rituxan
Tocilizumab will be administered as an IV infusion as per the methods described in the Summary of Product Characteristics (SmPC) or other similar local prescribing documents. Tocilizumab will be given as rescue medication.
Other names: Actemra
Cyclophosphamide 750 mg/m^2 administered IV on Day 1 of each 21-day cycle
Doxorubicin 50 mg/m^2 administered IV on Day 1 of each 21-day cycle
Vincristine 1.4 mg/m^2 administered by IV push on Day 1 of each 21-day cycle with a recommended cap of 2 mg
Other names: Oncovin
Prednisone 100 mg/day orally on Days 1-5 (prednisone on Day 1 may be administered IV, with the remaining doses on Days 2-5 to be administered orally) of each 21-day cycle
Polatuzumab vedotin 1.8 mg/kg administered IV on Day 1 of each 21-day cycle
Time frame: Up to 29 months
Time frame: Up to 29 months
Time frame: Up to 29 months
Time frame: Up to 29 months
Time frame: Up to 29 months
Time frame: Up to 29 months
Time frame: Up to 29 months
Time frame: Up to 29 months
Time frame: Up to 29 months
Time frame: Up to 29 months
Time frame: Cycle 1 Day 1 up to 29 months
Time frame: Cycle 1 Day 1 up to 29 months
Time frame: Cycle 1 Day 1 up to 29 months
Time frame: Cycle 1 Day 1 up to 29 months
Time frame: Up to 29 months
Hoffmann-La Roche
Industry
A Phase Ib Study Evaluating Glofitamab (RO7082859) in Combination With Rituximab (R) or Obinutuzumab (G) Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP), or Polatuzumab Vedotin (POLA) Plus Rituximab (R), Cyclophosphamide, Doxorubicin, and Prednisone (CHP) in Participants With Relapsed or Refractory Non-Hodgkin Lymphoma (R/R NHL) or in Participants With Untreated Diffuse Large B-Cell Lymphoma (DLBCL)
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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