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
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.
Checked against the public recordLast updated Jun 18, 2026 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Genentech, Inc.
- Interventions being studied
- Drug: RO7496353; Drug: Atezolizumab; Drug: Capecitabine; Drug: S-1; Drug: Nivolumab; Drug: Oxaliplatin; Drug: Nab-paclitaxel; Drug: Gemcitabine
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Life expectancy of at least 3 months * Adequate hematologic and end-organ function * Histologically confirmed locally advanced, recurrent, or metastatic incurable solid tumor malignancy * Measurable disease according to RECIST v1.1 on computed tomography (CT) or magnetic resonance imaging (MRI) images within 28 days prior to enrollment * Availability of representative tumor specimens in formalin-fixed, paraffin-embedded (FFPE) blocks or at least 15 unstained slides Exclusion Criteria: * Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, and/or radiotherapy, within 3 weeks prior to initiation of study treatment * Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases * Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina * History of leptomeningeal disease * Uncontrolled tumor-related pain * Positive test for human immunodeficiency virus (HIV) infection * Positive hepatitis B surface antigen (HbsAg) test, and/or positive total hepatitis B core antibody (HbcAb) test at screening * Positive hepatitis C virus (HCV) antibody test at screening * Known allergy or hypersensitivity to any component of the RO7496353 formulation or any of the study drugs or their excipients Other protocol-defined inclusion/exclusion criteria may apply.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- UCLA University of California Los AngelesLos Angeles, California
- Yale School of MedicineNew Haven, Connecticut
- Thomas Jefferson UniversityPhiladelphia, Pennsylvania
- St Vincent'S HospitalDarlinghurst, New South Wales
- Flinders Medical CentreBedford Park, South Australia
- Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS)Porto Alegre, Rio Grande do Sul
- Hospital de Câncer de BarretosBarretos, São Paulo
- Fondazione Policlinico Universitario A GemelliRome, Lazio
- ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda Ca' GrandaMilan, Lombardy
- Centro Ricerche Cliniche Di VeronaVerona, Veneto
- National Cancer Center Hospital EastChiba
- Kanagawa Cancer CenterKanagawa
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 18, 2026. Always confirm current availability with the study team.