Spots Global Cancer Trial Database for A Study of RO7293583 in Participants With Unresectable Metastatic Tyrosinase Related Protein 1 (TYRP1)-Positive Melanomas
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Trial Identification
Brief Title: A Study of RO7293583 in Participants With Unresectable Metastatic Tyrosinase Related Protein 1 (TYRP1)-Positive Melanomas
Official 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
Study ID: NCT04551352
Study Description
Brief 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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
Thomas Jefferson University Hospital;Medical Oncology, Philadelphia, Pennsylvania, United States
Sarah Cannon Research Institute, Nashville, Tennessee, United States
Peter Maccallum Cancer Institute; Clinical Trial Unit, Melbourne, Victoria, Australia
UZ Antwerpen, Edegem, , Belgium
UZ Leuven Gasthuisberg, Leuven, , Belgium
The Ottawa Hospital - General Campus, Ottawa, Ontario, Canada
Princess Margaret Cancer Center, Toronto, Ontario, Canada
Herlev Hospital; Afdeling for Kræftbehandling, Herlev, , Denmark
Clinica Universitaria de Navarra, Pamplona, Navarra, Spain
Vall d´Hebron Institute of Oncology (VHIO), Barcelona, Barcelona, , Spain
Clinica Universidad de Navarra Madrid; Servicio de Oncología, Madrid, , Spain
Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia, Valencia, , Spain
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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