NCT05867121CompletedPhase 1
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
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
Source: ClinicalTrials.gov · Last updated 18 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 102 (actual)
- First submitted
- 10 May 2023
- Start date
- 2 Oct 2023
- Primary completion date
- 16 Mar 2026
- Lead sponsor
- Genentech, Inc.
- NCT number
- NCT05867121
- EU CT number
- 2022-502615-11-00
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 102
- From 2 Oct 2023 to the primary completion date, 16 Mar 2026
- 27 sites in 9 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, and/or radiotherapy, within 3 weeks prior to initiation of study treatment
- 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
Other illness
- History of leptomeningeal disease
- 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.
Other
- Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
- Uncontrolled tumor-related pain
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (27)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Flinders Medical Centre Coordinator of this site? Confirm its status | Bedford Park | Australia | Unknown status |
| St Vincent's Hospital Coordinator of this site? Confirm its status | Darlinghurst | Australia | Unknown status |
| Hospital de Cancer de Barretos Coordinator of this site? Confirm its status | Barretos | Brazil | Unknown status |
| Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS) Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| Clinica Universidad de Navarra Madrid Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Clinica Universitaria de Navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Unknown status |
| NEXT Oncology - Hospital Quironsalud Madrid Coordinator of this site? Confirm its status | Pozuelo de Alarcón | Spain | Unknown status |
| Hospital Clinico Universitario de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
| ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda Ca' Granda Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Fondazione Policlinico Universitario A Gemelli Coordinator of this site? Confirm its status | Rome | Italy | Unknown status |
| Centro Ricerche Cliniche Di Verona Coordinator of this site? Confirm its status | Verona | Italy | Unknown status |
| National Cancer Center Hospital East Coordinator of this site? Confirm its status | Chiba | Japan | Unknown status |
| Kanagawa Cancer Center Coordinator of this site? Confirm its status | Kanagawa | Japan | Unknown status |
| Shizuoka Cancer Center Coordinator of this site? Confirm its status | Shizuoka | Japan | Unknown status |
| The Cancer Institute Hospital of Japanese Foundation for Cancer Research Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
| National Cancer Center Hospital Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
| Samsung Medical Center - PPDS Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| The Catholic University of Korea, Seoul ST. Mary's Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Severance Hospital Yonsei University Health System - Clinical Trials Center Pharmacy Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Auckland City Hospital Coordinator of this site? Confirm its status | Auckland | New Zealand | Unknown status |
| UCLA University of California Los Angeles Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Yale School of Medicine Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
| Thomas Jefferson University Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Ankara City Hospital Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| Dokuz Eylul Universitesi Tip Fakultesi Coordinator of this site? Confirm its status | Lzmir | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.