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Active (not recruiting) Phase 1 NCT05867121

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

Phase 1 – testing safety in a small group of people
Conditions: Non-small Cell Lung Cancer Gastric Cancer Pancreatic Ductal Adenocarcinoma

Sponsor: Genentech, Inc.

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Overview
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.
Who can 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.
Locations 9
Australia (1)
St Vincent'S Hospital
Darlinghurst , New South Wales
Brazil (1)
Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS)
Porto Alegre , Rio Grande do Sul
Italy (1)
Fondazione Policlinico Universitario A Gemelli
Rome , Lazio
Japan (1)
National Cancer Center Hospital East
Chiba
New Zealand (1)
Auckland City Hospital
Auckland
South Korea (1)
Seoul National University Hospital
Seoul
Spain (1)
NEXT Oncology-Hospital Quironsalud Madrid
Pozuelo de Alarcón , Madrid
Turkey (1)
Ankara City Hospital
Ankara
United States (1)
UCLA University of California Los Angeles
Los Angeles , California
Technical details
Status
Active (not recruiting)
Phase
Phase 1
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
02.10.2023
Completion date
30.06.2026
Registry ID
NCT05867121
Source
anzctr
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