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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

Full criteria on ClinicalTrials.gov

Sites (27)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Flinders Medical Centre
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Bedford ParkAustraliaUnknown status
St Vincent's Hospital
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DarlinghurstAustraliaUnknown status
Hospital de Cancer de Barretos
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BarretosBrazilUnknown status
Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS)
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Porto AlegreBrazilUnknown status
Clinica Universidad de Navarra Madrid
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MadridSpainUnknown status
Clinica Universitaria de Navarra
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PamplonaSpainUnknown status
NEXT Oncology - Hospital Quironsalud Madrid
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Pozuelo de AlarcónSpainUnknown status
Hospital Clinico Universitario de Valencia
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ValenciaSpainUnknown status
ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda Ca' Granda
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MilanItalyUnknown status
Fondazione Policlinico Universitario A Gemelli
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RomeItalyUnknown status
Centro Ricerche Cliniche Di Verona
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VeronaItalyUnknown status
National Cancer Center Hospital East
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ChibaJapanUnknown status
Kanagawa Cancer Center
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KanagawaJapanUnknown status
Shizuoka Cancer Center
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ShizuokaJapanUnknown status
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
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TokyoJapanUnknown status
National Cancer Center Hospital
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TokyoJapanUnknown status
Samsung Medical Center - PPDS
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SeoulSouth KoreaUnknown status
The Catholic University of Korea, Seoul ST. Mary's Hospital
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SeoulSouth KoreaUnknown status
Asan Medical Center
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SeoulSouth KoreaUnknown status
Severance Hospital Yonsei University Health System - Clinical Trials Center Pharmacy
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SeoulSouth KoreaUnknown status
Seoul National University Hospital
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SeoulSouth KoreaUnknown status
Auckland City Hospital
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AucklandNew ZealandUnknown status
UCLA University of California Los Angeles
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Los AngelesUnited StatesUnknown status
Yale School of Medicine
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New HavenUnited StatesUnknown status
Thomas Jefferson University
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PhiladelphiaUnited StatesUnknown status
Ankara City Hospital
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AnkaraTurkey (Türkiye)Unknown status
Dokuz Eylul Universitesi Tip Fakultesi
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LzmirTurkey (Türkiye)Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.