Gastric Cancer, Non-small Cell Lung Cancer, Pancreatic Ductal Adenocarcinoma
Conditions
Keywords
Urothelial Carcinoma
Brief summary
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.
Interventions
DRUGGemcitabine
Gemcitabine will be administered as per the schedule specified in the respective arm.
DRUGRO7496353
RO7496353 will be administered as per the schedules specified in the respective arms.
DRUGAtezolizumab
Atezolizumab will be administered as per the schedules specified in the respective arms.
DRUGCapecitabine
Capecitabine will be administered as per the schedule specified in the respective arm.
DRUGS-1
S-1 will be administered as per the schedule specified in the respective arm.
DRUGNivolumab
Nivolumab will be administered as per the schedule specified in the respective arm.
DRUGOxaliplatin
Oxaliplatin will be administered as per the schedule specified in the respective arm.
DRUGNab-paclitaxel
Nab-paclitaxel will be administered as per the schedule specified in the respective arm.
Sponsors
Genentech, Inc.
Chugai Pharmaceutical
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Adverse Events (AEs) | Up to approximately 33 months | AEs will be reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0). |
Secondary
| Measure | Time frame |
|---|---|
| Plasma Concentration of RO7496353 | Up to approximately 33 months |
| Percentage of Participants With Anti-drug Antibody (ADA) to RO7496353 | Up to approximately 33 months |
| Confirmed Objective Response Rate (ORR) as Determined by the Investigator per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) | Up to approximately 33 months |
| Duration of Response (DOR) as Determined by the Investigator per RECIST v1.1 | Up to approximately 33 months |
| Progression-free Survival (PFS) as Determined by the Investigator per RECIST v1.1 | Up to approximately 33 months |
Countries
Australia, Brazil, Italy, Japan, New Zealand, South Korea, Spain, Turkey (Türkiye), United States
Contacts
STUDY_DIRECTORClinical Trials
Hoffmann-La Roche
Outcome results
None listed