Trial Identifiers
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Scientific Title
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
Commercial Sponsor
Hoffmann-La Roche
Summary
This trial contains two dose escalation cohorts: single participant and multiple participant. In Part I (single participant cohorts), RO7293583 will be administered intravenously (IV) every three weeks (Q3W) at a starting dose of 0.045mg. The maximum dose explored in this part of the trial will be 1.5mg. In Part II (multiple participant cohorts), RO7293583 will be administered IV or SC every 3 weeks at a starting dose determined by Part I of the trial. Dose-escalation will be undertaken based on safety until determination of the maximum tolerated dose is reached. Fractionated, step up or subcutaneous (SC) dosing may be implemented. The maximum dose explored in Part II of the trial will be 600mg IV and 160mg SC.