Trial Identifiers
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Scientific Title
An Open-Label, Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of RO7443904 in Combination With Glofitamab in Participants With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma
Commercial Sponsor
Hoffmann-La Roche
Summary
This study has two stages: dose escalation and dose expansion. The Dose Escalation stage (Parts I-III) consists of RO7443904 and glofitamab will take place every three weeks (Q3W) with obinutuzumab pre-treatment. RO7443904 will be administered by subcutaneous (SC) or IV infusion on Cycle 2, Day 8. From Cycle 3 onward, RO7443904 will be given every 3 weeks (Q3W) for up to 12 cycles. Glofitamab will be administered through IV infusion starting with step-up dosing (2.5mg/10mg/30mg) on C1D1, C1D8, and C2D1. Starting in Cycle 3, glofitamab will be given in 30mg doses Q3W. with RO7443904 for up to 12 cycles. Obinutuzumab will be administered once through IV infusion at a dose of 1g dose in Cycle 1, on either Day -7, -4, or -3. Tocilizumab will be administered as necessary to treat cytokine release syndrome. The Dose Expansion stage (Part IV) will evaluate selected dose levels of RO7443904 in combination with glofitamab from Parts 1-III in a Q3W regimen with obinutuzumab pre-treatment.