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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

NCT05867121

CompletedPhase 1

Sponsor: Genentech, Inc.

Conditions: Non-small Cell Lung Cancer, Gastric Cancer, Pancreatic Ductal Adenocarcinoma

Interventions: RO7496353, Atezolizumab, Capecitabine, S-1, Nivolumab

Countries: United States, Australia, Brazil, Italy, Japan, New Zealand, South Korea, Spain

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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 (27)

Los Angeles, California, United States
New Haven, Connecticut, United States
Philadelphia, Pennsylvania, United States
Darlinghurst, New South Wales, Australia
Bedford Park, South Australia, Australia
Porto Alegre, Rio Grande do Sul, Brazil
Barretos, São Paulo, Brazil
Rome, Lazio, Italy
Milan, Lombardy, Italy
Verona, Veneto, Italy
Chiba, Japan
Kanagawa, Japan
Shizuoka, Japan
Tokyo, Japan
Tokyo, Japan
Auckland, New Zealand
Seoul, South Korea
Seoul, South Korea
Seoul, South Korea
Seoul, South Korea
Seoul, South Korea
Pozuelo de Alarcón, Madrid, Spain
Pamplona, Navarre, Spain
Madrid, Spain
Valencia, Spain
Ankara, Turkey (Türkiye)
Lzmir, Turkey (Türkiye)