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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
102
RO7496353 will be administered as per the schedules specified in the respective arms.
Atezolizumab will be administered as per the schedules specified in the respective arms.
Capecitabine will be administered as per the schedule specified in the respective arm.
S-1 will be administered as per the schedule specified in the respective arm.
Nivolumab will be administered as per the schedule specified in the respective arm.
Oxaliplatin will be administered as per the schedule specified in the respective arm.
Nab-paclitaxel will be administered as per the schedule specified in the respective arm.
Gemcitabine will be administered as per the schedule specified in the respective arm.
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
Percentage of Participants With Adverse Events (AEs)
AEs will be reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0).
Time frame: Up to approximately 33 months
Plasma Concentration of RO7496353
Time frame: Up to approximately 33 months
Percentage of Participants With Anti-drug Antibody (ADA) to RO7496353
Time frame: Up to approximately 33 months
Confirmed Objective Response Rate (ORR) as Determined by the Investigator per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Time frame: Up to approximately 33 months
Duration of Response (DOR) as Determined by the Investigator per RECIST v1.1
Time frame: Up to approximately 33 months
Progression-free Survival (PFS) as Determined by the Investigator per RECIST v1.1
Time frame: Up to approximately 33 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
...and 17 more locations