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
Completed · Phase 1
Conditions studied: Non-small Cell Lung Cancer, Gastric Cancer, Pancreatic Ductal Adenocarcinoma
In brief
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.
Key facts
- Study ID
- NCT05867121
- Run by
- Genentech, Inc.
- People needed
- 102
- Starts
- 2023-10-02
- Expected to finish
- 2026-03-16
- Last updated by the study team
- 2026-06-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- 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
- 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
- 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
Full record on ClinicalTrials.gov
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