Trial Title:
A Study to Evaluate the Safety, Pharmacokinetics, and 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
NCT ID:
NCT05867121
Condition:
Metastatic Solid Tumor
Non-small Cell Lung Cancer
Gastric Cancer
Pancreatic Ductal Adenocarcinoma
Conditions: Official terms:
Adenocarcinoma
Paclitaxel
Gemcitabine
Capecitabine
Nivolumab
Oxaliplatin
Atezolizumab
Tegafur
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
RO7496353
Description:
RO7496353 will be administered as per the schedules specified in the respective arms.
Arm group label:
Cohort A: NSCLC
Arm group label:
Cohort B: GC
Arm group label:
Cohort C: PDAC
Other name:
SOF 10
Intervention type:
Drug
Intervention name:
Atezolizumab
Description:
Atezolizumab will be administered as per the schedules specified in the respective arms.
Arm group label:
Cohort A: NSCLC
Arm group label:
Cohort C: PDAC
Other name:
RO554126 7; Tecentriq
Intervention type:
Drug
Intervention name:
Capecitabine
Description:
Capecitabine will be administered as per the schedules specified in the respective arms
Arm group label:
Cohort B: GC
Intervention type:
Drug
Intervention name:
S-1
Description:
S-1 will be administered as per the schedules specified in the respective arms.
Arm group label:
Cohort B: GC
Other name:
Tegafur/Gimeracil/Oteracil potassium
Intervention type:
Drug
Intervention name:
Nivolumab
Description:
Nivolumab will be administered as per the schedules specified in the respective arms.
Arm group label:
Cohort B: GC
Intervention type:
Drug
Intervention name:
Oxaliplatin
Description:
Oxaliplatin will be administered as per the schedules specified in the respective arms.
Arm group label:
Cohort B: GC
Intervention type:
Drug
Intervention name:
Nab-paclitaxel
Description:
Nab-paclitaxel will be administered as per the schedules specified in the respective
arms.
Arm group label:
Cohort C: PDAC
Intervention type:
Drug
Intervention name:
Gemcitabine
Description:
Gemcitabine will be administered as per the schedules specified in the respective arms.
Arm group label:
Cohort C: PDAC
Summary:
The purpose of this study is to evaluate the safety and tolerability of RO7496353 when
administered 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 study will be conducted in 2 stages: an
initial safety run-in stage and an expansion stage.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy 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:
- Pregnant or breastfeeding, or intending to become pregnant during the study or
within 9 months after the final dose of oxaliplatin and within 6 months after the
final dose of all other study 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
- 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.
Gender:
All
Gender based:
Yes
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
UCLA University of California Los Angeles
Address:
City:
Los Angeles
Zip:
90095
Country:
United States
Status:
Recruiting
Facility:
Name:
Yale School of Medicine
Address:
City:
New Haven
Zip:
06510-3206
Country:
United States
Status:
Recruiting
Facility:
Name:
Thomas Jefferson University
Address:
City:
Philadelphia
Zip:
19107
Country:
United States
Status:
Recruiting
Facility:
Name:
St Vincent'S Hospital
Address:
City:
Darlinghurst
Zip:
2010
Country:
Australia
Status:
Recruiting
Facility:
Name:
Flinders Medical Centre
Address:
City:
Bedford Park
Zip:
5042
Country:
Australia
Status:
Recruiting
Facility:
Name:
Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS)
Address:
City:
Porto Alegre
Zip:
90610-000
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Fondazione Policlinico Universitario A Gemelli
Address:
City:
Roma
Zip:
00168
Country:
Italy
Status:
Recruiting
Facility:
Name:
ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda Ca' Granda
Address:
City:
Milano
Zip:
20162
Country:
Italy
Status:
Recruiting
Facility:
Name:
Azienda Ospedaliera Universitaria Integrata di Verona
Address:
City:
Verona
Zip:
37126
Country:
Italy
Status:
Recruiting
Facility:
Name:
National Cancer Center Hospital East
Address:
City:
Chiba
Zip:
277-8577
Country:
Japan
Status:
Recruiting
Facility:
Name:
Kanagawa Cancer Center
Address:
City:
Kanagawa
Zip:
241-8515
Country:
Japan
Status:
Recruiting
Facility:
Name:
Shizuoka Cancer Center
Address:
City:
Shizuoka
Zip:
411-8777
Country:
Japan
Status:
Recruiting
Facility:
Name:
National Cancer Center Hospital
Address:
City:
Tokyo
Zip:
104-0045
Country:
Japan
Status:
Recruiting
Facility:
Name:
The Cancer Institute Hospital of Japanese Foundation For Cancer Research
Address:
City:
Tokyo
Zip:
135-8550
Country:
Japan
Status:
Recruiting
Facility:
Name:
Seoul National University Hospital
Address:
City:
Seoul
Zip:
03080
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Asan Medical Center
Address:
City:
Seoul
Zip:
05505
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Samsung Medical Center - PPDS
Address:
City:
Seoul
Zip:
06351
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Severance Hospital Yonsei University Health System - Clinical Trials Center Pharmacy
Address:
City:
Seoul
Zip:
120-752
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Auckland City Hospital
Address:
City:
Auckland
Zip:
1023
Country:
New Zealand
Status:
Recruiting
Facility:
Name:
Clinical Hospital Center Bezanijska Kosa; Physical Medicine and Rehabilitation
Address:
City:
Beograd-zemun
Zip:
11080
Country:
Serbia
Status:
Recruiting
Facility:
Name:
University Clinical Center of Serbia -PPDS
Address:
City:
Beograd
Zip:
11000
Country:
Serbia
Status:
Recruiting
Facility:
Name:
University Clinical Center Kragujevac; Clinic of neurology
Address:
City:
Kragujevac
Zip:
34000
Country:
Serbia
Status:
Recruiting
Facility:
Name:
NEXT Oncology-Hospital Quironsalud Madrid
Address:
City:
Pozuelo de Alarcon
Zip:
28223
Country:
Spain
Status:
Recruiting
Facility:
Name:
Clinica Universitaria de Navarra
Address:
City:
Pamplona
Zip:
31008
Country:
Spain
Status:
Recruiting
Facility:
Name:
Clinica Universidad de Navarra-Madrid
Address:
City:
Madrid
Zip:
28027
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Clinico Universitario de Valencia
Address:
City:
Valencia
Zip:
46010
Country:
Spain
Status:
Recruiting
Facility:
Name:
Ankara City Hospital; Oncology
Address:
City:
Ankara
Zip:
06800
Country:
Turkey
Status:
Recruiting
Facility:
Name:
Ege University Medical Faculty; Chest Diseases
Address:
City:
Izmir
Zip:
35040
Country:
Turkey
Status:
Recruiting
Facility:
Name:
Dokuz Eylul Universitesi Tip Fakultesi
Address:
City:
Lzmir
Zip:
35340
Country:
Turkey
Status:
Recruiting
Start date:
October 2, 2023
Completion date:
December 30, 2025
Lead sponsor:
Agency:
Genentech, Inc.
Agency class:
Industry
Collaborator:
Agency:
Chugai Pharmaceutical Co.
Agency class:
Other
Source:
Genentech, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05867121
