NCT04551352

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a first-in-human, multi-center 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.

Conditions

• Cutaneous Melanoma
• Uveal Melanoma
• Mucosal Melanoma

Interventions

Type	Name	Description
DRUG	RO7293583	RO7293583 will be administered at a dose and per schedule as specified for the respective cohort.
DRUG	Tocilizumab	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.

Timeline

• Start date: 2020-10-28
• Primary completion: 2022-07-28
• Completion: 2022-07-28
• First posted: 2020-09-16
• Last updated: 2022-10-03

Locations

14 sites across 6 countries: United States, Australia, Belgium, Canada, Denmark, Spain

Regulatory

• FDA-regulated drug study