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
NCT ID: NCT05867121
Last Updated: 2025-11-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
102 participants
INTERVENTIONAL
2023-10-02
2026-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Substudy: UC
Participants with UC will receive RO7496353, and atezolizumab, given as an IV infusion at an assigned dose on Day 1 of each 21-day cycle until unacceptable toxicity or symptomatic deterioration attributed to PD.
RO7496353
RO7496353 will be administered as per the schedules specified in the respective arms.
Atezolizumab
Atezolizumab will be administered as per the schedules specified in the respective arms.
Cohort A: NSCLC
Participants with NSCLC will receive RO7496353, and atezolizumab, given as an intravenous (IV) infusion at an assigned dose on Day 1 of each 21-day cycle until unacceptable toxicity or symptomatic deterioration attributed to disease progression (PD).
RO7496353
RO7496353 will be administered as per the schedules specified in the respective arms.
Atezolizumab
Atezolizumab will be administered as per the schedules specified in the respective arms.
Cohort B: GC
Participants with GC will receive RO7496353, nivolumab, and oxaliplatin, given as an IV infusion at an assigned dose on Day 1 of each 21-day cycle along with either capecitabine or S-1, orally, twice daily on Days 1 to 14 of each cycle until unacceptable toxicity or symptomatic deterioration attributed to PD.
RO7496353
RO7496353 will be administered as per the schedules specified in the respective arms.
Capecitabine
Capecitabine will be administered as per the schedule specified in the respective arm.
S-1
S-1 will be administered as per the schedule specified in the respective arm.
Nivolumab
Nivolumab will be administered as per the schedule specified in the respective arm.
Oxaliplatin
Oxaliplatin will be administered as per the schedule specified in the respective arm.
Cohort C: PDAC
Participants with PDAC will receive RO7496353, and atezolizumab, given as an IV infusion at an assigned dose on Days 1 and 15 of each 28-day cycle along with nab-paclitaxel, and gemcitabine, also given as an IV infusion on Days 1, 8, 15 of each 28-day cycle until unacceptable toxicity or symptomatic deterioration attributed to PD.
RO7496353
RO7496353 will be administered as per the schedules specified in the respective arms.
Atezolizumab
Atezolizumab will be administered as per the schedules specified in the respective arms.
Nab-paclitaxel
Nab-paclitaxel will be administered as per the schedule specified in the respective arm.
Gemcitabine
Gemcitabine will be administered as per the schedule specified in the respective arm.
Interventions
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RO7496353
RO7496353 will be administered as per the schedules specified in the respective arms.
Atezolizumab
Atezolizumab will be administered as per the schedules specified in the respective arms.
Capecitabine
Capecitabine will be administered as per the schedule specified in the respective arm.
S-1
S-1 will be administered as per the schedule specified in the respective arm.
Nivolumab
Nivolumab will be administered as per the schedule specified in the respective arm.
Oxaliplatin
Oxaliplatin will be administered as per the schedule specified in the respective arm.
Nab-paclitaxel
Nab-paclitaxel will be administered as per the schedule specified in the respective arm.
Gemcitabine
Gemcitabine will be administered as per the schedule specified in the respective arm.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Chugai Pharmaceutical
INDUSTRY
Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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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 de Clinicas de Porto Alegre (HCPA) - PPDS
Porto Alegre, Rio Grande do Sul, Brazil
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
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
Clinical Hospital Center Bezanijska Kosa
Belgrade, , Serbia
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
Ankara City Hospital
Ankara, , Turkey (Türkiye)
Dokuz Eylul Universitesi Tip Fakultesi
Lzmir, , Turkey (Türkiye)
Countries
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Other Identifiers
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2022-502615-11-00
Identifier Type: CTIS
Identifier Source: secondary_id
GO44010
Identifier Type: -
Identifier Source: org_study_id
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