A Study of RO7293583 in Participants With Unresectable Metastatic Tyrosinase Related Protein 1 (TYRP1)-Positive Melanomas

Official Title

An Open-Label, Multicentre, Phase 1 Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7293583, A TYRP1-Targeting CD3 T-Cell Engager, in Participants With Metastatic Melanoma

Summary:

This is a first-in-human, multi-centre clinical study to determine the safety, Maximum Tolerated Dose (MTD) and/or Optimal Biological Dose (OBD) as well as the optimal schedule for intravenous (IV) and/or subcutaneous (SC) administrations of RO7293583 with or without obinutuzumab pretreatment, in participants with unresectable metastatic TYRP1-positive melanomas who have progressed on standard of care (SOC) treatment, are intolerant to SOC, or are non-amenable to SOC. This study will include an initial single participant dose-escalation part one followed by a multiple participant dose-escalation part two with the possibility of expansion.

Trial Description

Primary Outcome:

• Percentage of Participants With Dose-Limiting Toxicities (DLTs)
• Percentage of Participants with Adverse Events (AEs)

• Maximum Concentration (Cmax) of RO7293583
• Time of Maximum Concentration (Tmax) of RO7293583
• Minimum Concentration (Cmin) of RO7293583
• SC Bioavailability (F) of RO7293583
• Clearance (CL) or Apparent Clearance (CL/F) of RO7293583
• Volume of Distribution at Steady State (Vss) of RO7293583
• Area Under the Curve (AUC) of RO7293583
• Percentage of Participants with Anti-Drug Antibodies (ADAs) to RO7293583
• Change from Baseline in RO7293583 ADA Titer
• Objective Response Rate (ORR)
• Disease Control Rate (DCR)
• Duration of Response (DOR)
• Progression-Free Survival (PFS)
• Overall Survival (OS)

View this trial on ClinicalTrials.gov