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An Open-Label, Multicenter, Phase 1 Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7293583, A TYRP1-Targeting CD3 T-Cell Engager, in Participants With Metastatic Melanoma
This is a non-randomised trial with two experimental parts. Part 1 focusses on dose escalation in single participant cohorts. Participants will receive RO7293583 (administered intravenously) every three weeks (Q3W). The starting dose will be 0.045mg and the maximum dose explored will be 1.5mg. Tocilizumab will be administered as required for the management of severe cytokine release syndrome (CRS). Part 2 focuses on multiple ascending dose-escalation of RO7293583 in multiple participant cohorts. The starting-dose for the initiation of the IV dose-escalation will be determined by Part I and RO7293583 will be administered intravenously or subcutaneously every three weeks. Dose-escalation will be undertaken based on safety until determination of the MTD or the highest safe dose if MTD is not reached. Fractionated, step up or subcutaneous dosing may be implemented. The maximum dose explored will be 600mg IV and 160mg SC.Tocilizumab will be administered as required for the management of severe cytokine release syndrome (CRS). Drug: Obinutuzumab
If implemented, it will be given either on D-7 or D-7 and D-6. Drug: Adalimumab
If implemented, it will be given as a single dose approximately 6 days prior to the first dose of RO7293583.