- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05867121
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
April 15, 2024 updated by: Genentech, Inc.
A Phase Ib, Open-Label, Multicenter Dose-Expansion Study Evaluating the Safety, Pharmacokinetics, and Activity of RO7496353 in Combination With a Checkpoint Inhibitor With or Without Standard-of-Care Chemotherapy in Patients With Locally Advanced or Metastatic Solid Tumors
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.
Study Overview
Status
Recruiting
Conditions
Study Type
Interventional
Enrollment (Estimated)
120
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Reference Study ID Number: GO44010 https://forpatients.roche.com/
- Phone Number: 888-662-6728 (U.S. Only)
- Email: global-roche-genentech-trials@gene.com
Study Locations
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New South Wales
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Darlinghurst, New South Wales, Australia, 2010
- Recruiting
- St Vincent's Hospital
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South Australia
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Bedford Park, South Australia, Australia, 5042
- Recruiting
- Flinders Medical Centre
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RS
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Porto Alegre, RS, Brazil, 90610-000
- Recruiting
- Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS)
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Lazio
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Roma, Lazio, Italy, 00168
- Recruiting
- Fondazione Policlinico Universitario A Gemelli
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Veneto
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Verona, Veneto, Italy, 37126
- Recruiting
- Azienda Ospedaliera Universitaria Integrata di Verona
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Chiba, Japan, 277-8577
- Recruiting
- National Cancer Center Hospital East
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Kanagawa, Japan, 241-8515
- Recruiting
- Kanagawa Cancer Center
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Shizuoka, Japan, 411-8777
- Recruiting
- Shizuoka Cancer Center
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Tokyo, Japan, 104-0045
- Recruiting
- National Cancer Center Hospital
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Tokyo, Japan, 135-8550
- Recruiting
- The Cancer Institute Hospital of Japanese Foundation for Cancer Research
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Seoul, Korea, Republic of, 03080
- Recruiting
- Seoul National University Hospital
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Seoul, Korea, Republic of, 05505
- Recruiting
- Asan Medical Center
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Seoul, Korea, Republic of, 06351
- Recruiting
- Samsung Medical Center - PPDS
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Seoul, Korea, Republic of, 120-752
- Recruiting
- Severance Hospital Yonsei University Health System - Clinical Trials Center Pharmacy
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Auckland, New Zealand, 1023
- Recruiting
- Auckland City Hospital
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Madrid, Spain, 28027
- Recruiting
- Clinica Universidad de Navarra-Madrid
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Valencia, Spain, 46010
- Recruiting
- Hospital Clinico Universitario de Valencia
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Madrid
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Pozuelo de Alarcon, Madrid, Spain, 28223
- Recruiting
- NEXT Oncology-Hospital Quironsalud Madrid
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Navarra
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Pamplona, Navarra, Spain, 31008
- Recruiting
- Clinica Universitaria de Navarra
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California
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Los Angeles, California, United States, 90095
- Recruiting
- UCLA University of California Los Angeles
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Connecticut
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New Haven, Connecticut, United States, 06510-3206
- Recruiting
- Yale School of Medicine
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19107
- Recruiting
- Thomas Jefferson University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
Atezolizumab will be administered as per the schedules specified in the respective arms.
Other Names:
RO7496353 will be administered as per the schedules specified in the respective arms.
Other Names:
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Experimental: 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 disease progression.
|
RO7496353 will be administered as per the schedules specified in the respective arms.
Other Names:
Capecitabine will be administered as per the schedules specified in the respective arms
S-1 will be administered as per the schedules specified in the respective arms.
Other Names:
Nivolumab will be administered as per the schedules specified in the respective arms.
Oxaliplatin will be administered as per the schedules specified in the respective arms.
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Experimental: 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 disease progression.
|
Atezolizumab will be administered as per the schedules specified in the respective arms.
Other Names:
RO7496353 will be administered as per the schedules specified in the respective arms.
Other Names:
Nab-paclitaxel will be administered as per the schedules specified in the respective arms.
Gemcitabine will be administered as per the schedules specified in the respective arms.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants with Adverse Events (AEs)
Time Frame: Up to approximately 29 months
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AEs will be reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0).
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Up to approximately 29 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Plasma Concentration of RO7496353
Time Frame: Up to approximately 29 months
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Up to approximately 29 months
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Percentage of Participants with Anti-Drug Antibody (ADA) to RO7496353
Time Frame: Up to approximately 29 months
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Up to approximately 29 months
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Confirmed Objective Response Rate (ORR) as Determined by the Investigator per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Time Frame: Up to approximately 29 months
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Up to approximately 29 months
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Duration of Response (DOR) as Determined by the Investigator per RECIST v1.1
Time Frame: Up to approximately 29 months
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Up to approximately 29 months
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Progression Free Survival (PFS) as Determined by the Investigator per RECIST v1.1
Time Frame: Up to approximately 29 months
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Up to approximately 29 months
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Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cohort A and C: Serum Concentration of Atezolizumab
Time Frame: Up to approximately 29 months
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Up to approximately 29 months
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Cohort A and C: Percentage of Participants with ADA to Atezolizumab
Time Frame: Up to approximately 29 months
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Up to approximately 29 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Clinical Trials, Hoffmann-La Roche
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 2, 2023
Primary Completion (Estimated)
December 30, 2025
Study Completion (Estimated)
December 30, 2025
Study Registration Dates
First Submitted
May 10, 2023
First Submitted That Met QC Criteria
May 10, 2023
First Posted (Actual)
May 19, 2023
Study Record Updates
Last Update Posted (Estimated)
April 16, 2024
Last Update Submitted That Met QC Criteria
April 15, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Adenocarcinoma
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Antineoplastic Agents, Immunological
- Immune Checkpoint Inhibitors
- Paclitaxel
- Capecitabine
- Oxaliplatin
- Nivolumab
- Atezolizumab
- Tegafur
- Gemcitabine
Other Study ID Numbers
- GO44010
- 2022-502615-11-00 (Other Identifier: EU Clinical Trial Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org).
Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/).
For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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