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A Study to Evaluate Safety, Pharmacokinetics, & Activity of RO7496353 in Combination With a Checkpoint Inhibitor With or Without Standard-of-care Chemotherapy in Participants With Locally Advanced or Metastatic Solid Tumors; Urothelial Carcinoma Substudy in Association With RO7496353 Study GO44010
Sponsor: Genentech, Inc.
Summary
The purpose of this study is to evaluate the safety and tolerability of RO7496353 in combination with a checkpoint inhibitor (CPI) with or without standard-of-care (SOC) chemotherapy in participants with locally advanced or metastatic solid tumors such as non-small cell lung cancer (NSCLC), gastric cancer (GC) and pancreatic ductal adenocarcinoma (PDAC). The substudy will evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary anti-tumor activity of RO7496353 in combination with atezolizumab in patients with locally advanced or metastatic urothelial carcinoma (UC). The parent and substudy will be conducted in 2 stages: an initial safety run-in stage and an expansion stage.
Official title: A Phase Ib, Open-label, Multicenter Dose-expansion Study Evaluating the Safety, Pharmacokinetics, and Activity of RO7496353 in Combination With a Checkpoint Inhibitor With or Without Standard-of-care Chemotherapy in Patients With Locally Advanced or Metastatic Solid Tumors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
102
Start Date
2023-10-02
Completion Date
2026-06-30
Last Updated
2026-02-02
Healthy Volunteers
No
Interventions
RO7496353
RO7496353 will be administered as per the schedules specified in the respective arms.
Atezolizumab
Atezolizumab will be administered as per the schedules specified in the respective arms.
Capecitabine
Capecitabine will be administered as per the schedule specified in the respective arm.
S-1
S-1 will be administered as per the schedule specified in the respective arm.
Nivolumab
Nivolumab will be administered as per the schedule specified in the respective arm.
Oxaliplatin
Oxaliplatin will be administered as per the schedule specified in the respective arm.
Nab-paclitaxel
Nab-paclitaxel will be administered as per the schedule specified in the respective arm.
Gemcitabine
Gemcitabine will be administered as per the schedule specified in the respective arm.
Locations (27)
UCLA University of California Los Angeles
Los Angeles, California, United States
Yale School of Medicine
New Haven, Connecticut, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
St Vincent'S Hospital
Darlinghurst, New South Wales, Australia
Flinders Medical Centre
Bedford Park, South Australia, Australia
Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS)
Porto Alegre, Rio Grande do Sul, Brazil
Hospital de Câncer de Barretos
Barretos, São Paulo, Brazil
Fondazione Policlinico Universitario A Gemelli
Rome, Lazio, Italy
ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda Ca' Granda
Milan, Lombardy, Italy
Centro Ricerche Cliniche Di Verona
Verona, Veneto, Italy
National Cancer Center Hospital East
Chiba, Japan
Kanagawa Cancer Center
Kanagawa, Japan
Shizuoka Cancer Center
Shizuoka, Japan
National Cancer Center Hospital
Tokyo, Japan
The Cancer Institute Hospital of Japanese Foundation For Cancer Research
Tokyo, Japan
Auckland City Hospital
Auckland, New Zealand
Seoul National University Hospital
Seoul, South Korea
Asan Medical Center
Seoul, South Korea
Samsung Medical Center - PPDS
Seoul, South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, South Korea
Severance Hospital Yonsei University Health System - Clinical Trials Center Pharmacy
Seoul, South Korea
NEXT Oncology-Hospital Quironsalud Madrid
Pozuelo de Alarcón, Madrid, Spain
Clinica Universitaria de Navarra
Pamplona, Navarre, Spain
Clinica Universidad de Navarra-Madrid
Madrid, Spain
Hospital Clinico Universitario de Valencia
Valencia, Spain
Ankara City Hospital
Ankara, Turkey (Türkiye)
Dokuz Eylul Universitesi Tip Fakultesi
Lzmir, Turkey (Türkiye)