Spots Global Cancer Trial Database for A Study to Evaluate the Safety, Pharmacokinetics, and Anti-Tumor Activity of RO7589831 in Participants With Advanced Solid Tumors
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Trial Identification
Brief Title: A Study to Evaluate the Safety, Pharmacokinetics, and Anti-Tumor Activity of RO7589831 in Participants With Advanced Solid Tumors
Official Title: A Phase I, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Anti-Tumor Activity of RO7589831 in Participants With Advanced Solid Tumors Harboring Microsatellite Instability (MSI) and/or Deficient Mismatch Repair (dMMR)
Study ID: NCT06004245
Conditions
Interventions
Study Description
Brief Summary: This is a first-in-human, Phase I, open-label, multicenter, dose-escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of RO7589831 monotherapy in participants with microsatellite instability (MSI) and/or deficient mismatch repair (dMMR) advanced solid tumors. RO7589831 is an oral drug that acts on a protein called Werner (WRN), which may promote the growth of cancers that are MSI and/or dMMR. By acting on WRN, RO7589831 may be able to block the growth of these types of cancer.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
City of Hope, Duarte, California, United States
City of Hope at Irvine Lennar, Irvine, California, United States
Duke University; Office of Research Contracts, Durham, North Carolina, United States
SCRI Oncology Partners, Nashville, Tennessee, United States
MD Anderson Cancer Center, Houston, Texas, United States
UZ Leuven Gasthuisberg, Leuven, , Belgium
BCCA-Vancouver Cancer Centre, Vancouver, British Columbia, Canada
Princess Margaret Cancer Center, Toronto, Ontario, Canada
Rigshospitalet; Onkologisk Klinik, København Ø, , Denmark
CLCC Leon Berard Lyon, Lyon, , France
Gustave Roussy, Villejuif, , France
Clinica Universitaria de Navarra; Servicio de Oncologia, Pamplona, Navarra, Spain
Vall d?Hebron Institute of Oncology (VHIO), Barcelona, Barcelona, , Spain
Clinica Universidad de Navarra Madrid; Servicio de Oncología, Madrid, , Spain
START Madrid. Centro Integral Oncologico Clara Campal; CIOCC, Madrid, , Spain
Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia, Valencia, , Spain
Royal Marsden Hospital - Fulham, London, , United Kingdom
Sarah Cannon Research Institute, London, , United Kingdom
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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